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

Study Overview
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Brief Summary
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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.

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

Conditions
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Glaucoma, Dry Eyes

Intervention / Treatment
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* Drug: Refresh Tears Lubricant Eye Drops (Allergan)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Refresh Tears Lubricant Eye Drops (Allergan)<br>Artificial tears eye drops QID for 1 month | Drug: Refresh Tears Lubricant Eye Drops (Allergan)<br>* Eye drops QID for 1 month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Surface Staining | Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence | At baseline (dispensing visit) | 
| Ocular Surface Staining | Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence | After 1 week | 
| Ocular Surface Staining | Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence | After 1 month | 
| 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 . | At baseline (dispensing visit) | 
| 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 . | After 1 week | 
| 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 . | After 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 1 month after using artificial tears | 
| 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). | At baseline (dispensing visit) | 
| 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). | 1 week after using artificial tears |