Clinical trial NCT01682460: Pilot Study on the Use of Artificial Tears to Treat Dry Eye in Glaucoma Patients
Official title: Pilot Study on the Use of Artificial Tears to Treat Dry Eye in Glaucoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Dry Eyes
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2012-09-11
Enrollment: 15
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Ocular Surface Staining
timeFrame: At baseline (dispensing visit)
measure: Ocular Surface Staining
timeFrame: After 1 week
measure: Ocular Surface Staining
timeFrame: After 1 month
measure: Tear Break up Time With Fluorescein
timeFrame: At baseline (dispensing visit)
measure: Tear Break up Time With Fluorescein
timeFrame: After 1 week
measure: Tear Break up Time With Fluorescein
timeFrame: After 1 month
Secondary outcomes:
measure: Ocular Surface Disease Index (OSDI) Score
timeFrame: At baseline (dispensing visit)
measure: Ocular Surface Disease Index (OSDI) Score
timeFrame: 1 week after using artificial tears
measure: Ocular Surface Disease Index (OSDI) Score
timeFrame: 1 month after using artificial tears
Other outcomes:
measure: Subjective Ratings of Comfort
timeFrame: At baseline (dispensing visit)
measure: Subjective Ratings of Comfort
timeFrame: 1 week after using artificial tears
measure: Subjective Ratings of Comfort
timeFrame: 1 month after using artificial tears
Locations:
city: Waterloo
country: Canada
facility: Centre for Contact Lens Research, University of Waterloo
state: Ontario
Study officials:
affiliation: University of Waterloo
name: Lyndon Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References: