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

NCT ID: NCT01682460

Last Updated: 2017-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-04-30

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.

Conditions

Glaucoma; Dry Eyes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Refresh Tears Lubricant Eye Drops (Allergan)

Artificial tears eye drops QID for 1 month

Group Type: EXPERIMENTAL

Refresh Tears Lubricant Eye Drops (Allergan)

Intervention Type: DRUG

Eye drops QID for 1 month

Interventions

Refresh Tears Lubricant Eye Drops (Allergan)

Eye drops QID for 1 month

Intervention Type: DRUG

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.

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

University of Waterloo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lyndon Jones, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Waterloo

Locations

Centre for Contact Lens Research, University of Waterloo

Waterloo, Ontario, Canada

Countries

Canada

Other Identifiers

18262

Identifier Type: -

Identifier Source: org_study_id