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

University of Waterloo

Status and phase

Completed

Phase 4

Conditions

Dry Eyes

Glaucoma

Treatments

Drug: Refresh Tears Lubricant Eye Drops (Allergan)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01682460

18262

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

17+ years old

Volunteers

No 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.