<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/NCT04465071</url>
  </required_header>
  <id_info>
    <org_study_id>276400</org_study_id>
    <nct_id>NCT04465071</nct_id>
  </id_info>
  <brief_title>Lubricating Eye Drops After Routine Cataract Surgery</brief_title>
  <official_title>Patient Satisfaction,Dry Symptoms in Patients Cataract Surgery in NHS Patients Treated With Prophylactic Preservative-free Lubricant Eye Drops (AEONTM Repair, and AEONTM Protect Plus): A Randomized, Prospective, Controlled Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guy's and St Thomas' NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>City, University of London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Guy's and St Thomas' NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patient satisfaction and dry symptoms in patients undergoing routine uncomplicated cataract&#xD;
      surgery in NHS patients treated with prophylactic phosphate-free, preservative-free lubricant&#xD;
      eye drops (0.3% cross linked sodium hyaluronate, AEONTM Protect Plus and0.15% Sodium&#xD;
      Hyalu-ronate with vitamins A and E, AEONTM Repair): A randomized, prospective, controlled&#xD;
      study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to investigate the routine use of such lubricating drops in a&#xD;
      randomized, prospective methodology in patients undergoing uncomplicated cataract surgery in&#xD;
      the NHS setting. As these drops are provided with the intraocular lens, if found to be of&#xD;
      benefit in reducing dry eye problems such a study might provide evidence for the universal&#xD;
      implementa-tion of post-operative ocular lubricant drops&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 24, 2020</start_date>
  <completion_date type="Actual">August 31, 2022</completion_date>
  <primary_completion_date type="Actual">August 31, 2022</primary_completion_date>
  <phase>N/A</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>To assess the use of additional lubricant eye-drops for 6 weeks following uncomplicated, routine cataract sur-gery to improve patient satisfaction and symptoms of dry eye in an NHS (public health care) setting, compared to no additional lubricating eye drops</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>No masking</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>CATPROM 5 patient satisfaction score</measure>
    <time_frame>Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change</time_frame>
    <description>Quality of life patient satisfaction questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>EQ5D3L patient satisfaction score</measure>
    <time_frame>Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change</time_frame>
    <description>Quality of life patient satisfaction questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dry Eye Symptoms</measure>
    <time_frame>Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change</time_frame>
    <description>Patient questionnaire SPEED II score (Maximum 28, Minimum 0)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Acuity</measure>
    <time_frame>2 week follow up and 2 month follow up</time_frame>
    <description>Logmar Visual Acuity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cornea and Conjunctival Staining</measure>
    <time_frame>2 week follow up and 2 month follow up</time_frame>
    <description>Oxford Scale (Maximum 5, minimum 0)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Schirmer 1 Test</measure>
    <time_frame>2 week follow up and 2 month follow up</time_frame>
    <description>Schirmer 1 Test (Normal &gt;10 mm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tear Break up time</measure>
    <time_frame>2 week follow up and 2 month follow up</time_frame>
    <description>Non-invasive tear breakup time (normal &gt;10 seconds)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inferior tear meniscus</measure>
    <time_frame>2 week follow up and 2 month follow up</time_frame>
    <description>Inferior tear meniscus</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corneal Incision site and size</measure>
    <time_frame>2 week follow up and 2 month follow up</time_frame>
    <description>Corneal Incision site and size</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">79</enrollment>
  <condition>Dry Eye</condition>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>Standard Treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Post-Cataract surgery standard treatment of Maxidex 0.1% QDS for 4 weeks, and Chloramphenicol drops QDS for 2 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Treatment plus lubricating drops</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Lubricant eye-drops (0.3% cross linked sodium hyaluronate, AEONTM Protect Plus and phosphate-free, preservative-free lubricant eye drops containing 0.15% Sodium Hyaluronate with vita-mins A and E (AEONTM Repair) for 6 weeks post-Cataract surgery, in addition to the standard treatment of Maxidex 0.1% QDS for 4 weeks, and Chloramphenicol drops QDS for 2 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AEONTM Repair and AEONTM Protect Plus lubricating eye drops</intervention_name>
    <description>AEONTM Repair and AEONTM Protect Plus lubricating eye drops</description>
    <arm_group_label>Standard Treatment plus lubricating drops</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Bilateral or unilateral cataracts requiring surgical intervention&#xD;
&#xD;
          2. Age over 18 years&#xD;
&#xD;
          3. Able to understand informed consent and the objectives of the trial&#xD;
&#xD;
          4. Not pregnant, not breast feeding&#xD;
&#xD;
          5. No previous eye surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. age-related macula degeneration&#xD;
&#xD;
          2. glaucoma&#xD;
&#xD;
          3. previous retinal vascular disorders&#xD;
&#xD;
          4. previous retinal detachment or tear&#xD;
&#xD;
          5. any neuro-ophthalmological condition&#xD;
&#xD;
          6. any inherited retinal disorder or pathology&#xD;
&#xD;
          7. previous strabismus surgery or record of amblyopia&#xD;
&#xD;
          8. previous TIA, CVA or other vaso-occlusive disease&#xD;
&#xD;
          9. already enrolled in another study&#xD;
&#xD;
         10. already on prescribed lubricating drops&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Guys' and St.Thomas' Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>February 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>September 8, 2023</last_update_submitted>
  <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ophthalmic Solutions</mesh_term>
    <mesh_term>Lubricant Eye Drops</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04465071
org study id: 276400
nct id: NCT04465071
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patient satisfaction and dry symptoms in patients undergoing routine uncomplicated cataract
      surgery in NHS patients treated with prophylactic phosphate-free, preservative-free lubricant
      eye drops (0.3% cross linked sodium hyaluronate, AEONTM Protect Plus and0.15% Sodium
      Hyalu-ronate with vitamins A and E, AEONTM Repair): A randomized, prospective, controlled
      study.
The aim of this study is to investigate the routine use of such lubricating drops in a
      randomized, prospective methodology in patients undergoing uncomplicated cataract surgery in
      the NHS setting. As these drops are provided with the intraocular lens, if found to be of
      benefit in reducing dry eye problems such a study might provide evidence for the universal
      implementa-tion of post-operative ocular lubricant drops
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: To assess the use of additional lubricant eye-drops for 6 weeks following uncomplicated, routine cataract sur-gery to improve patient satisfaction and symptoms of dry eye in an NHS (public health care) setting, compared to no additional lubricating eye drops
primary purpose: Supportive Care
masking: None (Open Label)
masking description: No masking
measure: CATPROM 5 patient satisfaction score
time frame: Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change
description: Quality of life patient satisfaction questionnaire
measure: EQ5D3L patient satisfaction score
time frame: Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change
description: Quality of life patient satisfaction questionnaire
measure: Dry Eye Symptoms
time frame: Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change
description: Patient questionnaire SPEED II score (Maximum 28, Minimum 0)
measure: Visual Acuity
time frame: 2 week follow up and 2 month follow up
description: Logmar Visual Acuity
measure: Cornea and Conjunctival Staining
time frame: 2 week follow up and 2 month follow up
description: Oxford Scale (Maximum 5, minimum 0)
measure: Schirmer 1 Test
time frame: 2 week follow up and 2 month follow up
description: Schirmer 1 Test (Normal >10 mm)
measure: Tear Break up time
time frame: 2 week follow up and 2 month follow up
description: Non-invasive tear breakup time (normal >10 seconds)
measure: Inferior tear meniscus
time frame: 2 week follow up and 2 month follow up
description: Inferior tear meniscus
measure: Corneal Incision site and size
time frame: 2 week follow up and 2 month follow up
description: Corneal Incision site and size
arm group label: Standard Treatment
arm group type: No Intervention
description: Post-Cataract surgery standard treatment of Maxidex 0.1% QDS for 4 weeks, and Chloramphenicol drops QDS for 2 weeks
arm group label: Standard Treatment plus lubricating drops
arm group type: Other
description: Lubricant eye-drops (0.3% cross linked sodium hyaluronate, AEONTM Protect Plus and phosphate-free, preservative-free lubricant eye drops containing 0.15% Sodium Hyaluronate with vita-mins A and E (AEONTM Repair) for 6 weeks post-Cataract surgery, in addition to the standard treatment of Maxidex 0.1% QDS for 4 weeks, and Chloramphenicol drops QDS for 2 weeks
intervention type: Drug
intervention name: AEONTM Repair and AEONTM Protect Plus lubricating eye drops
description: AEONTM Repair and AEONTM Protect Plus lubricating eye drops
arm group label: Standard Treatment plus lubricating drops
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Cataract
mesh term: Ophthalmic Solutions
mesh term: Lubricant Eye Drops
sharing ipd: No