<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04440280</url>
  </required_header>
  <id_info>
    <org_study_id>2020P001909</org_study_id>
    <nct_id>NCT04440280</nct_id>
  </id_info>
  <brief_title>Targeting Reactive Oxygen Species Production as a Novel Therapeutic in Fuch's Endothelial Corneal Dystrophy</brief_title>
  <official_title>Targeting Reactive Oxygen Species Production as a Novel Therapeutic in Fuch's Endothelial Corneal Dystrophy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts Eye and Ear Infirmary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts Eye and Ear Infirmary</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This protocol will investigate whether topical application of N-acetyl cysteine (NAC) eye&#xD;
      drops decreases oxidative stress and confers cytoprotection in patients with FECD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fuchs Endothelial Corneal Dystrophy (FECD) is the most common corneal endothelial disorder&#xD;
      and has been estimated to affect approximately 4% of the US population over the age of 40.&#xD;
      Corneal transplantation is currently the primary treatment modality available to treat FECD,&#xD;
      and there are no medical therapies that treat the disease or stall its progression.&#xD;
      Therefore, there is an unmet need to identify pharmacotherapeutic interventions that would&#xD;
      prevent the endothelial cell loss in early through late stages of FECD, as well as after&#xD;
      corneal transplantation, aiding in the survival of the corneal grafts.&#xD;
&#xD;
      The investigators know that cell loss in FECD is caused by increased oxidative stress in the&#xD;
      CEC and aqueous humor of FECD. The investigators have in vitro and in vivo data showing that&#xD;
      the processes involved in the development of FECD can be arrested with administration of&#xD;
      N-acetyl cysteine (NAC). Currently topical solutions of NAC are already used in ophthalmology&#xD;
      for application in keratoconjunctivitis sicca (using 20% weight/volume solution or 10%),&#xD;
      meibomian gland dysfunction (using 5%) and Sjögren's dry eye syndrome (also using 5%).&#xD;
&#xD;
      This is a single center, double-blind, placebo-controlled, randomized trial. Adult&#xD;
      participants with advanced FECD and cataracts who qualify for the standard treatment&#xD;
      (combined Descemet Membrane Endothelial Keratoplasty (DMEK) and cataract surgery) will be&#xD;
      enrolled at Massachusetts Eye and Ear.&#xD;
&#xD;
      After meeting eligibility criteria and completing informed consent, 30 eyes from up to 30&#xD;
      participants with advanced FECD and cataracts with indication for combined DMEK and cataract&#xD;
      surgery will be initially enrolled. (NOTE: Some participants may be enrolled twice if they&#xD;
      elect to have both eyes treated within the study.) Eyes will be randomized 1:1 to NAC 10% and&#xD;
      the placebo, Visine Tears Dry Eye Relief artificial tears ophthalmic solution. Each&#xD;
      participant will self-administer 1 drop of study drug four times a day in the planned&#xD;
      operative eye for 28 days prior to planned surgery.&#xD;
&#xD;
      After interim analysis of the study with 30 eyes, if a significant difference in the primary&#xD;
      endpoint between NAC 10% and placebo is not found, an additional 15 eyes from up to 15&#xD;
      participants will be enrolled and assigned to 20% NAC.&#xD;
&#xD;
      Prior to and after using the study medication, participants will complete patient-reported&#xD;
      visual disability questionnaires and have corneal measurements and images taken. Participants&#xD;
      additionally will complete a tolerability and medication adherence questionnaire after using&#xD;
      the study medication.&#xD;
&#xD;
      In the operating room, a standard incision will be made to collect the fluid from the&#xD;
      anterior part of the eye and replaced with a salt solution or viscous agent routinely used&#xD;
      during the surgery. This procedure is routinely performed during this type of surgery,&#xD;
      however, some of the aqueous fluid will be collected and analyzed rather than being&#xD;
      discarded. Additionally, corneal tissue which is normally removed during corneal&#xD;
      transplantation surgery and discarded will be kept for further research on FECD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 16, 2020</start_date>
  <completion_date type="Anticipated">April 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Initially, 30 eyes from up to 30 participants will be randomized 1:1 to one of two groups, a group administering N-acetyl cysteine (NAC) 10% and a group administering Visine Tears Dry Eye Relief artificial tears ophthalmic solution (the placebo).&#xD;
After interim analysis of the study with 30 eyes, if a significant difference in the primary endpoint between NAC 10% and placebo is not found, an additional 15 eyes from up to 15 participants will be enrolled to investigate 20% NAC.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>This is a double-blind trial, where neither the study participant nor the investigators will know to which treatment group the study participant has been assigned.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Level of H2O2 in the aqueous humor</measure>
    <time_frame>DMEK Surgery occurs 28 to 42 days after participant enrollment</time_frame>
    <description>The primary endpoint is the level of H2O2 in the aqueous humor obtained at time of DMEK surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of safety of NAC eye drops in patients with FECD by documenting the number and severity of adverse events.</measure>
    <time_frame>Ongoing safety assessment will occur starting on the first day when subjects receive the study drug, through the pre-operative visit, surgery and post-surgical follow-up visits, a period of approximately 6-7 weeks.</time_frame>
    <description>Safety assessment will be ongoing for the entire 28 days that study participants take study drug (prior to surgery) and in all post surgical follow-up visits. Assessment will be based on the number and severity of adverse events, with specific scrutiny for evidence of severe ocular adverse reactions such as ocular chemosis, severe injection, presence or worsening of corneal epithelial staining and/or epithelial defects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability of N-acetyl cysteine drops in patients with FECD by documenting participants' reports of irritation, burning, itchiness or redness in their eyes while taking the study drug</measure>
    <time_frame>Tolerability will be assessed after participants have taken study drug for 28 days or earlier, if the participants report difficulties tolerating the drug.</time_frame>
    <description>Participants will be asked to fill out a tolerability and medication adherence questionnaire where they will rate the irritation, burning, itchiness and redness they experience after using the medication on a scale of 1 to 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in patient-reported visual disability after NAC administration</measure>
    <time_frame>Assessed when subject starts study drug and again, 21 to 28 days later.</time_frame>
    <description>Change in patient-reported visual disability will be obtained using the previously validated questionnaire, V-FUCHS instrument 10 before and after the study drug is administered. Participants will be asked how often they experience specific visual difficulties selecting from the following choices: never, rarely, sometimes, most of the time or all of the time. Participants will also be asked how much difficulty they have performing certain visual tasks. Options for the answers are: No difficulty, a little difficulty, moderate difficulty, a lot of difficulty or extreme difficulty.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in central corneal thickness after NAC administration</measure>
    <time_frame>Assessed when subject starts study drug and again, 21 to 28 days later.</time_frame>
    <description>Change in central corneal thickness as measured by CCT; decrease by &gt;30 µm before and after NAC drop administration period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in corneal endothelial cell counts after NAC administration</measure>
    <time_frame>Assessed when subject starts study drug and again, 21 to 28 days later.</time_frame>
    <description>Change in the number of corneal endothelial cells as determined by HRT3 with Rostock Corneal Module (Heidelberg Engineering, Heidelberg, Germany) before and after NAC drop administration period. If central counts are unattainable due to end-stage of FECD, then peripheral counts will be obtained.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in corneal tomography after NAC administration</measure>
    <time_frame>Assessed when subject starts study drug and again, 21 to 28 days later.</time_frame>
    <description>Corneal tomography is a three-dimensional imaging technique that characterizes the anterior/posterior corneal surfaces. Participants will have corneal tomography twice: first before they start the study drug, and then again, 28 to 42 days later when the drug treatment has concluded. Change in corneal tomography imaging will be assessed qualitatively.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Fuchs Endothelial Corneal Dystrophy</condition>
  <arm_group>
    <arm_group_label>NAC 10% group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in this group will be treated with eye drops containing a 10% solution of N-acetyl cysteine. Topical NAC is a well-tolerated medication that has many applications in ophthalmology including dry eye disease and meibomian gland dysfunction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NAC 20% group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in this group will be treated with eye drops containing a 20% solution of N-acetyl cysteine. Topical NAC is a well-tolerated medication that has many applications in ophthalmology including dry eye disease and meibomian gland dysfunction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects in this group will be treated with a placebo (Visine Tears Dry Eye Relief artificial tears ophthalmic solution.)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>N-acetyl cysteine (NAC) 10% solution</intervention_name>
    <description>N-acetyl cysteine is a sterile, unpreserved eye drop containing 10% (100 mg/mL) of acetylcysteine.</description>
    <arm_group_label>NAC 10% group</arm_group_label>
    <other_name>acetylcysteine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>N-acetyl cysteine (NAC) 20% solution</intervention_name>
    <description>N-acetyl cysteine is a sterile, unpreserved eye drop containing 20% (200 mg/mL) of acetylcysteine.</description>
    <arm_group_label>NAC 20% group</arm_group_label>
    <other_name>acetylcysteine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Visine Dry Eye Relief eye drops</intervention_name>
    <description>Visine Tears Dry Eye Relief artificial tears ophthalmic solution</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female ≥21 years of age at time of surgical evaluation.&#xD;
&#xD;
          2. Diagnosis of advanced FECD and visually significant cataract&#xD;
&#xD;
          3. Indication for DMEK (Descemet Membrane Endothelial Keratoplasty) with concurrent&#xD;
             cataract surgery&#xD;
&#xD;
          4. Written informed consent obtained from subject and ability for subject to comply with&#xD;
             the requirements of the study.&#xD;
&#xD;
          5. Willingness and ability to adhere to medication regimen&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant, breastfeeding, or unwilling to practice birth control during participation&#xD;
             in the study.&#xD;
&#xD;
          2. History of prior intraocular surgery in study eye including cataract, glaucoma and/or&#xD;
             retina surgery&#xD;
&#xD;
          3. History of other corneal diseases, such as severe dry eye, corneal scars, pseudophakic&#xD;
             bullous keratopathy, corneal degenerations, corneal infections&#xD;
&#xD;
          4. Use of ocular prescription medications except for lubricants, hyperosmotic agents, or&#xD;
             ocular hypotensive agents&#xD;
&#xD;
          5. History of ocular surface infection within the past 30 days&#xD;
&#xD;
          6. Use of systemic, inhalational, or topical N-Acetylcysteine within the past 30 days&#xD;
&#xD;
          7. History of intolerance to topical N-Acetylcysteine&#xD;
&#xD;
          8. Presence of a condition or abnormality that in the opinion of the Investigator would&#xD;
             compromise the safety of the patient or the quality of the data.&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ula Jurkunas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts Eye and Ear</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kevin Ma, MD</last_name>
    <phone>6175737900</phone>
    <email>kevin_ma@meei.harvard.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Stacey Ellender, PhD</last_name>
    <phone>857-231-1593</phone>
    <email>stacey_ellender@meei.harvard.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Massachusetts Eye and Ear Infirmary</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stacey Ellender</last_name>
      <phone>857-231-1593</phone>
      <email>stacey_ellender@meei.harvard.edu</email>
    </contact>
    <contact_backup>
      <last_name>Ula Jurkunas, MD</last_name>
      <phone>6175734330</phone>
      <phone_ext>Jurkunas</phone_ext>
      <email>Ula_Jurkunas@meei.harvard.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Ula Jurkunas, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>January 25, 2023</last_update_submitted>
  <last_update_submitted_qc>January 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts Eye and Ear Infirmary</investigator_affiliation>
    <investigator_full_name>Ula Jurkunas</investigator_full_name>
    <investigator_title>Associate Professor, Harvard Medical School</investigator_title>
  </responsible_party>
  <keyword>Fuchs</keyword>
  <keyword>Fuchs Endothelial Corneal Dystrophy</keyword>
  <keyword>oxidative stress</keyword>
  <keyword>N-Acetylcysteine ophthalmic drops</keyword>
  <keyword>Descemet Membrane Endothelial Keratoplasty</keyword>
  <keyword>DMEK</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Corneal Dystrophies, Hereditary</mesh_term>
    <mesh_term>Fuchs' Endothelial Dystrophy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetylcysteine</mesh_term>
    <mesh_term>Pharmaceutical Solutions</mesh_term>
    <mesh_term>Ophthalmic Solutions</mesh_term>
    <mesh_term>N-monoacetylcystine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04440280
org study id: 2020P001909
nct id: NCT04440280
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This protocol will investigate whether topical application of N-acetyl cysteine (NAC) eye
      drops decreases oxidative stress and confers cytoprotection in patients with FECD.
Fuchs Endothelial Corneal Dystrophy (FECD) is the most common corneal endothelial disorder
      and has been estimated to affect approximately 4% of the US population over the age of 40.
      Corneal transplantation is currently the primary treatment modality available to treat FECD,
      and there are no medical therapies that treat the disease or stall its progression.
      Therefore, there is an unmet need to identify pharmacotherapeutic interventions that would
      prevent the endothelial cell loss in early through late stages of FECD, as well as after
      corneal transplantation, aiding in the survival of the corneal grafts.

      The investigators know that cell loss in FECD is caused by increased oxidative stress in the
      CEC and aqueous humor of FECD. The investigators have in vitro and in vivo data showing that
      the processes involved in the development of FECD can be arrested with administration of
      N-acetyl cysteine (NAC). Currently topical solutions of NAC are already used in ophthalmology
      for application in keratoconjunctivitis sicca (using 20% weight/volume solution or 10%),
      meibomian gland dysfunction (using 5%) and Sjögren's dry eye syndrome (also using 5%).

      This is a single center, double-blind, placebo-controlled, randomized trial. Adult
      participants with advanced FECD and cataracts who qualify for the standard treatment
      (combined Descemet Membrane Endothelial Keratoplasty (DMEK) and cataract surgery) will be
      enrolled at Massachusetts Eye and Ear.

      After meeting eligibility criteria and completing informed consent, 30 eyes from up to 30
      participants with advanced FECD and cataracts with indication for combined DMEK and cataract
      surgery will be initially enrolled. (NOTE: Some participants may be enrolled twice if they
      elect to have both eyes treated within the study.) Eyes will be randomized 1:1 to NAC 10% and
      the placebo, Visine Tears Dry Eye Relief artificial tears ophthalmic solution. Each
      participant will self-administer 1 drop of study drug four times a day in the planned
      operative eye for 28 days prior to planned surgery.

      After interim analysis of the study with 30 eyes, if a significant difference in the primary
      endpoint between NAC 10% and placebo is not found, an additional 15 eyes from up to 15
      participants will be enrolled and assigned to 20% NAC.

      Prior to and after using the study medication, participants will complete patient-reported
      visual disability questionnaires and have corneal measurements and images taken. Participants
      additionally will complete a tolerability and medication adherence questionnaire after using
      the study medication.

      In the operating room, a standard incision will be made to collect the fluid from the
      anterior part of the eye and replaced with a salt solution or viscous agent routinely used
      during the surgery. This procedure is routinely performed during this type of surgery,
      however, some of the aqueous fluid will be collected and analyzed rather than being
      discarded. Additionally, corneal tissue which is normally removed during corneal
      transplantation surgery and discarded will be kept for further research on FECD.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Initially, 30 eyes from up to 30 participants will be randomized 1:1 to one of two groups, a group administering N-acetyl cysteine (NAC) 10% and a group administering Visine Tears Dry Eye Relief artificial tears ophthalmic solution (the placebo).
After interim analysis of the study with 30 eyes, if a significant difference in the primary endpoint between NAC 10% and placebo is not found, an additional 15 eyes from up to 15 participants will be enrolled to investigate 20% NAC.
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: This is a double-blind trial, where neither the study participant nor the investigators will know to which treatment group the study participant has been assigned.
measure: Level of H2O2 in the aqueous humor
time frame: DMEK Surgery occurs 28 to 42 days after participant enrollment
description: The primary endpoint is the level of H2O2 in the aqueous humor obtained at time of DMEK surgery.
measure: Assessment of safety of NAC eye drops in patients with FECD by documenting the number and severity of adverse events.
time frame: Ongoing safety assessment will occur starting on the first day when subjects receive the study drug, through the pre-operative visit, surgery and post-surgical follow-up visits, a period of approximately 6-7 weeks.
description: Safety assessment will be ongoing for the entire 28 days that study participants take study drug (prior to surgery) and in all post surgical follow-up visits. Assessment will be based on the number and severity of adverse events, with specific scrutiny for evidence of severe ocular adverse reactions such as ocular chemosis, severe injection, presence or worsening of corneal epithelial staining and/or epithelial defects.
measure: Assessment of tolerability of N-acetyl cysteine drops in patients with FECD by documenting participants' reports of irritation, burning, itchiness or redness in their eyes while taking the study drug
time frame: Tolerability will be assessed after participants have taken study drug for 28 days or earlier, if the participants report difficulties tolerating the drug.
description: Participants will be asked to fill out a tolerability and medication adherence questionnaire where they will rate the irritation, burning, itchiness and redness they experience after using the medication on a scale of 1 to 100.
measure: Change in patient-reported visual disability after NAC administration
time frame: Assessed when subject starts study drug and again, 21 to 28 days later.
description: Change in patient-reported visual disability will be obtained using the previously validated questionnaire, V-FUCHS instrument 10 before and after the study drug is administered. Participants will be asked how often they experience specific visual difficulties selecting from the following choices: never, rarely, sometimes, most of the time or all of the time. Participants will also be asked how much difficulty they have performing certain visual tasks. Options for the answers are: No difficulty, a little difficulty, moderate difficulty, a lot of difficulty or extreme difficulty.
measure: Change in central corneal thickness after NAC administration
time frame: Assessed when subject starts study drug and again, 21 to 28 days later.
description: Change in central corneal thickness as measured by CCT; decrease by >30 µm before and after NAC drop administration period.
measure: Change in corneal endothelial cell counts after NAC administration
time frame: Assessed when subject starts study drug and again, 21 to 28 days later.
description: Change in the number of corneal endothelial cells as determined by HRT3 with Rostock Corneal Module (Heidelberg Engineering, Heidelberg, Germany) before and after NAC drop administration period. If central counts are unattainable due to end-stage of FECD, then peripheral counts will be obtained.
measure: Changes in corneal tomography after NAC administration
time frame: Assessed when subject starts study drug and again, 21 to 28 days later.
description: Corneal tomography is a three-dimensional imaging technique that characterizes the anterior/posterior corneal surfaces. Participants will have corneal tomography twice: first before they start the study drug, and then again, 28 to 42 days later when the drug treatment has concluded. Change in corneal tomography imaging will be assessed qualitatively.
arm group label: NAC 10% group
arm group type: Active Comparator
description: Subjects in this group will be treated with eye drops containing a 10% solution of N-acetyl cysteine. Topical NAC is a well-tolerated medication that has many applications in ophthalmology including dry eye disease and meibomian gland dysfunction.
arm group label: NAC 20% group
arm group type: Active Comparator
description: Subjects in this group will be treated with eye drops containing a 20% solution of N-acetyl cysteine. Topical NAC is a well-tolerated medication that has many applications in ophthalmology including dry eye disease and meibomian gland dysfunction.
arm group label: Placebo group
arm group type: Placebo Comparator
description: Subjects in this group will be treated with a placebo (Visine Tears Dry Eye Relief artificial tears ophthalmic solution.)
intervention type: Drug
intervention name: N-acetyl cysteine (NAC) 10% solution
description: N-acetyl cysteine is a sterile, unpreserved eye drop containing 10% (100 mg/mL) of acetylcysteine.
arm group label: NAC 10% group
other name: acetylcysteine
intervention type: Drug
intervention name: N-acetyl cysteine (NAC) 20% solution
description: N-acetyl cysteine is a sterile, unpreserved eye drop containing 20% (200 mg/mL) of acetylcysteine.
arm group label: NAC 20% group
other name: acetylcysteine
intervention type: Drug
intervention name: Visine Dry Eye Relief eye drops
description: Visine Tears Dry Eye Relief artificial tears ophthalmic solution
arm group label: Placebo group
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Ula Jurkunas, MD
role: Principal Investigator
affiliation: Massachusetts Eye and Ear
last name: Kevin Ma, MD
phone: 6175737900
email: kevin_ma@meei.harvard.edu
last name: Stacey Ellender, PhD
phone: 857-231-1593
email: stacey_ellender@meei.harvard.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts Eye and Ear Infirmary
investigator full name: Ula Jurkunas
investigator title: Associate Professor, Harvard Medical School
mesh term: Corneal Dystrophies, Hereditary
mesh term: Fuchs' Endothelial Dystrophy
mesh term: Acetylcysteine
mesh term: Pharmaceutical Solutions
mesh term: Ophthalmic Solutions
mesh term: N-monoacetylcystine