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Pilot Study on the Use of Artificial Tears to Treat Dry Eye in Glaucoma Patients (IVES)

Primary Purpose

Glaucoma, Dry Eyes

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Refresh Tears Lubricant Eye Drops (Allergan)
Sponsored by
University of Waterloo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 17 years of age and has full legal capacity to volunteer;
  • Has read and signed an information consent letter;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Is a current non-contact lens wearer.
  • Has previously been diagnosed with primary open angle glaucoma and is currently being treated with a topical therapeutic agent.
  • The glaucoma medication dosage and usage must have been the same for >6 months.
  • Shows a minimum score of 2 (sometimes) on the SESOD questionnaire.
  • Distance VA of at least 20/40 in each eye with current spectacle correction.

Exclusion Criteria:

  • Is participating in any concurrent clinical or research study;
  • Has any known active* ocular disease and/or infection; except primary open angle glaucoma.
  • Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  • Is using any systemic or topical medications (with the exception of glaucoma medication) that in the opinion of the investigator may affect a study outcome variable;
  • Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  • Is pregnant, lactating or planning a pregnancy at the time of enrolment;
  • Has undergone refractive error surgery;
  • Is an employee of the Centre for Contact Lens Research;
  • Has taken part in another (pharmaceutical) research study within the last 30 days;

  • Is currently using artificial tears more than 3 times per day.

    • For the purposes of this study, active ocular disease is defined as infection or inflammation that requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Sites / Locations

  • Centre for Contact Lens Research, University of Waterloo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Refresh Tears Lubricant Eye Drops (Allergan)

Arm Description

Artificial tears eye drops QID for 1 month

Outcomes

Primary Outcome Measures

Ocular Surface Staining
Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence
Ocular Surface Staining
Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence
Ocular Surface Staining
Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence
Tear Break up Time With Fluorescein
The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .
Tear Break up Time With Fluorescein
The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .
Tear Break up Time With Fluorescein
The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .

Secondary Outcome Measures

Ocular Surface Disease Index (OSDI) Score
The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score).
Ocular Surface Disease Index (OSDI) Score
The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score).
Ocular Surface Disease Index (OSDI) Score
The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worse possible score).

Full Information

First Posted
August 29, 2012
Last Updated
May 1, 2017
Sponsor
University of Waterloo
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT01682460
Brief Title
Pilot Study on the Use of Artificial Tears to Treat Dry Eye in Glaucoma Patients
Acronym
IVES
Official Title
Pilot Study on the Use of Artificial Tears to Treat Dry Eye in Glaucoma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Waterloo
Collaborators
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Research indicates that many people who are being treated for glaucoma have dry eyes. The purpose of this study is to test the use of artificial tears to alleviate dryness signs and symptoms in people who are using medication to treat glaucoma. The study hypothesis is that the use of artificial tears will result in an improvement in clinical signs and symptoms associated with dry eyes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Dry Eyes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Refresh Tears Lubricant Eye Drops (Allergan)
Arm Type
Experimental
Arm Description
Artificial tears eye drops QID for 1 month
Intervention Type
Drug
Intervention Name(s)
Refresh Tears Lubricant Eye Drops (Allergan)
Intervention Description
Eye drops QID for 1 month
Primary Outcome Measure Information:
Title
Ocular Surface Staining
Description
Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence
Time Frame
At baseline (dispensing visit)
Title
Ocular Surface Staining
Description
Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence
Time Frame
After 1 week
Title
Ocular Surface Staining
Description
Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence
Time Frame
After 1 month
Title
Tear Break up Time With Fluorescein
Description
The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .
Time Frame
At baseline (dispensing visit)
Title
Tear Break up Time With Fluorescein
Description
The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .
Time Frame
After 1 week
Title
Tear Break up Time With Fluorescein
Description
The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .
Time Frame
After 1 month
Secondary Outcome Measure Information:
Title
Ocular Surface Disease Index (OSDI) Score
Description
The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score).
Time Frame
At baseline (dispensing visit)
Title
Ocular Surface Disease Index (OSDI) Score
Description
The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score).
Time Frame
1 week after using artificial tears
Title
Ocular Surface Disease Index (OSDI) Score
Description
The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worse possible score).
Time Frame
1 month after using artificial tears
Other Pre-specified Outcome Measures:
Title
Subjective Ratings of Comfort
Description
Participants completed a standardized grading scale regarding their subjective ratings of comfort (0 = very poor comfort, 100=excellent comfort)
Time Frame
At baseline (dispensing visit)
Title
Subjective Ratings of Comfort
Description
Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0= very poor comfort, 100=excellent comfort)
Time Frame
1 week after using artificial tears
Title
Subjective Ratings of Comfort
Description
Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0=very poor comfort, 0 = excellent comfort)
Time Frame
1 month after using artificial tears

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 17 years of age and has full legal capacity to volunteer; Has read and signed an information consent letter; Is willing and able to follow instructions and maintain the appointment schedule; Is a current non-contact lens wearer. Has previously been diagnosed with primary open angle glaucoma and is currently being treated with a topical therapeutic agent. The glaucoma medication dosage and usage must have been the same for >6 months. Shows a minimum score of 2 (sometimes) on the SESOD questionnaire. Distance VA of at least 20/40 in each eye with current spectacle correction. Exclusion Criteria: Is participating in any concurrent clinical or research study; Has any known active* ocular disease and/or infection; except primary open angle glaucoma. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; Is using any systemic or topical medications (with the exception of glaucoma medication) that in the opinion of the investigator may affect a study outcome variable; Has known sensitivity to the diagnostic pharmaceuticals to be used in the study; Is pregnant, lactating or planning a pregnancy at the time of enrolment; Has undergone refractive error surgery; Is an employee of the Centre for Contact Lens Research; Has taken part in another (pharmaceutical) research study within the last 30 days; Is currently using artificial tears more than 3 times per day. For the purposes of this study, active ocular disease is defined as infection or inflammation that requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyndon Jones, PhD
Organizational Affiliation
University of Waterloo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Contact Lens Research, University of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada

12. IPD Sharing Statement

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Pilot Study on the Use of Artificial Tears to Treat Dry Eye in Glaucoma Patients

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