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

Phase 4

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Refresh Tears Lubricant Eye Drops (Allergan)	Refresh Tears Lubricant Eye Drops (Allergan)	Artificial tears eye drops QID for 1 month

Primary Outcome Measures

Name	Time	Method
Ocular Surface Staining	After 1 month	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	After 1 month	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

Name	Time	Method
Ocular Surface Disease Index (OSDI) Score	1 month after using artificial tears	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).