<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/NCT01704248</url>
  </required_header>
  <id_info>
    <org_study_id>440/2555 (EC4)</org_study_id>
    <nct_id>NCT01704248</nct_id>
  </id_info>
  <brief_title>The Effect of &quot;Eye Drop Guide&quot; on the Success Rate of Eye Drops Self-instillation in Glaucoma Patients</brief_title>
  <official_title>The Effect of &quot;Eye Drop Guide&quot; on the Success Rate of Eye Drops Self-instillation in Glaucoma Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate if the Eye Drop Guide more effective than carefully instructed routine&#xD;
      technique for chronic glaucoma patients to self-instill eye drops.&#xD;
&#xD;
      And what factors are associated with the failure of self-instillation eye drops with the Eye&#xD;
      Drop Guide?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The participants are randomized into 2 groups. For group I; the participants will be&#xD;
      instructed to use the Eye Drop Guide first while for group II; the participants will be&#xD;
      instructed to use the routine self-instillation technique first. The instruction will be&#xD;
      given to all participants by the same investigator. The participants are allowed to practice&#xD;
      until confidence in the techniques to which they are assigned. The participants then are&#xD;
      instructed to use only that technique to instill eye drops in both eyes every day and keep&#xD;
      the diary to document the date, time of practice, and number of bottles use in each eye for&#xD;
      practice at home. The investigators make a telephone visit at 1 week to remind the practice&#xD;
      routine and the follow up schedule. The 2 week follow up will be scheduled to evaluate the&#xD;
      self-instillation performance using the techniques to which they are assigned by the VDO&#xD;
      recordings under the same setting as Day 1.&#xD;
&#xD;
      After VDO recordings the participants will be switched to receive the other technique with&#xD;
      the same instruction as the other group. Allow the same period of practice in the hospital&#xD;
      and at home. The investigators again will make a 1-week telephone visit and 2-week follow up&#xD;
      after self-practice at home. At week 4 the VDO recordings of self-instillation performance&#xD;
      will be taken again under the same setting as previous records.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">April 2013</completion_date>
  <primary_completion_date type="Anticipated">February 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To compare the success rate of self-instillation eye drops between carefully instructed routine technique and the use of Eye Drop Guide.</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>1. To compare the total number of drops dispensed and time to instill drop between 2 groups.</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2. To identify the factors that associated with failure of using the Eye Drop Guide.</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Eye Drops Self-instillation</condition>
  <arm_group>
    <arm_group_label>Routine self-instillation technique</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The participants first use the Routine self-instillation technique for two weeks and then switch to the Eye Drop Guide technique for another two weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Eye Drop Guide technique</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants first use the Eye Drop Guide technique for two weeks and then switch to the Routine self-instillation technique for another two weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Eye Drop Guide technique</intervention_name>
    <description>Wash the hands.&#xD;
Shake and then uncap the bottle.&#xD;
Hold the bottle between the thumb, index, and/or middle finger of the dominant hand.&#xD;
Use the lower lip of the cup to pull the lower lid down like what they normally do with the fingers.&#xD;
Then place the upper lip down to cover the whole orbital rim area.&#xD;
Tilt the head back if seated or standing.&#xD;
Insert the bottle in the device all the way. Hold the bottle gently.&#xD;
Look upward.&#xD;
Squeeze the bottle one drop at a time until feel one drop instilled into the eye.&#xD;
Close the eye 2-3 minutes.&#xD;
For the non-seeing eye (best-corrected visual acuity ≤ 20/400) the participants should insert the bottle in the device before cover the eye then proceed with head tilt and look upward.</description>
    <arm_group_label>Routine self-instillation technique</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Routine self-instillation technique</intervention_name>
    <description>Wash the hands.&#xD;
Shake and then uncap the bottle.&#xD;
Hold the bottle between the thumb, index, and/or middle finger of the dominant hand.&#xD;
Lie down or tilt the head back if seated or standing.&#xD;
Using the other hand, pull the lower lid down.&#xD;
Hold the bottle over the eye and look up.&#xD;
Squeeze the bottle one drop at a time until feel one drop instilled into the eye.&#xD;
Close the eye 2-3 minutes.&#xD;
For the participants using more than one medication after instilling one bottle the participants should wait 3-5 minutes between administering different medications in the same eye.</description>
    <arm_group_label>Eye Drop Guide technique</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have been diagnosed of chronic glaucoma for 3 months or longer&#xD;
&#xD;
          -  Age of 18 years or over&#xD;
&#xD;
          -  Self-administer eye drops regularly&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Perioperative patients&#xD;
&#xD;
          -  Patients who were blind from other diseases&#xD;
&#xD;
          -  Patients with ophthalmic conditions that affect the eye drop instillation e.g.&#xD;
             nystagmus, ptosis, exophthalmos, enophthalmos, microphthalmos, symblepharon,&#xD;
             restrictive ophthalmoplegia&#xD;
&#xD;
          -  Patients whose underlying conditions would affect the patient's adherence to the&#xD;
             protocol e.g. dementia, psychosis, mental retardation, neurological conditions&#xD;
             resulting in tremor or paralysis, rheumatoid arthritis, hand deformities&#xD;
&#xD;
          -  Patients who are allergic to artificial tears eye drop&#xD;
&#xD;
          -  Patients who are not able to return for the follow-up schedule&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Darin Sakiyalak, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mahidol University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Darin Sakiyalak, MD</last_name>
    <phone>66204198033-4</phone>
    <email>darin.sak@mahidol.ac.th</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculty of Medicine, Siriraj Hospital, Mahidol University</name>
      <address>
        <city>Bangkok</city>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Darin Sakiyalak, MD</last_name>
      <phone>6624198033-4</phone>
      <email>darin.sak@mahidol.ac.th</email>
    </contact>
    <investigator>
      <last_name>Darin Sakiyalak, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>October 10, 2012</last_update_submitted>
  <last_update_submitted_qc>October 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 11, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>eye drops self-instillation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ophthalmic Solutions</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/NCT01704248
org study id: 440/2555 (EC4)
nct id: NCT01704248
lead sponsor: 
has dmc: No
To investigate if the Eye Drop Guide more effective than carefully instructed routine
      technique for chronic glaucoma patients to self-instill eye drops.

      And what factors are associated with the failure of self-instillation eye drops with the Eye
      Drop Guide?
The participants are randomized into 2 groups. For group I; the participants will be
      instructed to use the Eye Drop Guide first while for group II; the participants will be
      instructed to use the routine self-instillation technique first. The instruction will be
      given to all participants by the same investigator. The participants are allowed to practice
      until confidence in the techniques to which they are assigned. The participants then are
      instructed to use only that technique to instill eye drops in both eyes every day and keep
      the diary to document the date, time of practice, and number of bottles use in each eye for
      practice at home. The investigators make a telephone visit at 1 week to remind the practice
      routine and the follow up schedule. The 2 week follow up will be scheduled to evaluate the
      self-instillation performance using the techniques to which they are assigned by the VDO
      recordings under the same setting as Day 1.

      After VDO recordings the participants will be switched to receive the other technique with
      the same instruction as the other group. Allow the same period of practice in the hospital
      and at home. The investigators again will make a 1-week telephone visit and 2-week follow up
      after self-practice at home. At week 4 the VDO recordings of self-instillation performance
      will be taken again under the same setting as previous records.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: To compare the success rate of self-instillation eye drops between carefully instructed routine technique and the use of Eye Drop Guide.
time frame: 1 month
measure: 1. To compare the total number of drops dispensed and time to instill drop between 2 groups.
time frame: 1 month
measure: 2. To identify the factors that associated with failure of using the Eye Drop Guide.
time frame: 1 month
arm group label: Routine self-instillation technique
arm group type: Placebo Comparator
description: The participants first use the Routine self-instillation technique for two weeks and then switch to the Eye Drop Guide technique for another two weeks.
arm group label: Eye Drop Guide technique
arm group type: Experimental
description: The participants first use the Eye Drop Guide technique for two weeks and then switch to the Routine self-instillation technique for another two weeks.
intervention type: Device
intervention name: Eye Drop Guide technique
description: Wash the hands.
Shake and then uncap the bottle.
Hold the bottle between the thumb, index, and/or middle finger of the dominant hand.
Use the lower lip of the cup to pull the lower lid down like what they normally do with the fingers.
Then place the upper lip down to cover the whole orbital rim area.
Tilt the head back if seated or standing.
Insert the bottle in the device all the way. Hold the bottle gently.
Look upward.
Squeeze the bottle one drop at a time until feel one drop instilled into the eye.
Close the eye 2-3 minutes.
For the non-seeing eye (best-corrected visual acuity ≤ 20/400) the participants should insert the bottle in the device before cover the eye then proceed with head tilt and look upward.
arm group label: Routine self-instillation technique
intervention type: Behavioral
intervention name: Routine self-instillation technique
description: Wash the hands.
Shake and then uncap the bottle.
Hold the bottle between the thumb, index, and/or middle finger of the dominant hand.
Lie down or tilt the head back if seated or standing.
Using the other hand, pull the lower lid down.
Hold the bottle over the eye and look up.
Squeeze the bottle one drop at a time until feel one drop instilled into the eye.
Close the eye 2-3 minutes.
For the participants using more than one medication after instilling one bottle the participants should wait 3-5 minutes between administering different medications in the same eye.
arm group label: Eye Drop Guide technique
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Darin Sakiyalak, MD
role: Principal Investigator
affiliation: Mahidol University
last name: Darin Sakiyalak, MD
phone: 66204198033-4
email: darin.sak@mahidol.ac.th
facility: 
status: Recruiting
contact: 
investigator: 
country: Thailand
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Ophthalmic Solutions