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

NCT01682460 | Completed Phase 4 Results

• 1 other identifier: 18262
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Ocular Surface Staining

  Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= \>30 dots + confluence

  At baseline (dispensing visit)

• Ocular Surface Staining

  Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= \>30 dots + confluence

  After 1 week

• Ocular Surface Staining

  Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= \>30 dots + confluence

  After 1 month

• Tear Break up Time With Fluorescein

  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 .

  At baseline (dispensing visit)

• Tear Break up Time With Fluorescein

  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 .

  After 1 week

• Tear Break up Time With Fluorescein

  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 .

  After 1 month

Secondary Outcomes (3)

• Ocular Surface Disease Index (OSDI) Score

  At baseline (dispensing visit)

• Ocular Surface Disease Index (OSDI) Score

  1 week after using artificial tears

• Ocular Surface Disease Index (OSDI) Score

  1 month after using artificial tears

Other Outcomes (3)

• Subjective Ratings of Comfort

  At baseline (dispensing visit)

• Subjective Ratings of Comfort

  1 week after using artificial tears

• Subjective Ratings of Comfort

  1 month after using artificial tears

Study Arms (1)

Refresh Tears Lubricant Eye Drops (Allergan)

EXPERIMENTAL

Artificial tears eye drops QID for 1 month

Drug: Refresh Tears Lubricant Eye Drops (Allergan)

Interventions

Refresh Tears Lubricant Eye Drops (Allergan) DRUG

Eye drops QID for 1 month

Refresh Tears Lubricant Eye Drops (Allergan)

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Waterloo: lead
• Allergan: collaborator

Study Sites (1)

Centre for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Glaucoma; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Lacrimal Apparatus Diseases

Results Point of Contact

• Title: Research Manager
• Organization: CCLR

cclr2@sciborg.uwaterloo.ca

519-888-4742

Study Officials

• Lyndon Jones, PhD

  University of Waterloo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2012
• First Posted: September 11, 2012
• Study Start: August 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: June 5, 2017
• Results First Posted: July 3, 2014

Record last verified: 2017-05

Locations

CA (1)