Pilot Study on the Use of Artificial Tears to Treat Dry Eye in Glaucoma Patients
Condition: Glaucoma; Dry Eyes
MeSH terms: Glaucoma; Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: Refresh Tears Lubricant Eye Drops (Allergan)
Intervention description: Eye drops QID for 1 month
Intervention MeSH terms: Ophthalmic Solutions; Lubricant Eye Drops
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 17 Years
Healthy volunteers: No

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.
    

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.