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

• ClinicalTrials.gov Identifier: NCT01682460
• Recruitment Status: Completed
• First Posted: September 11, 2012
• Results First Posted: July 3, 2014
• Last Update Posted: June 5, 2017
• Sponsor: University of Waterloo
• Collaborator: Allergan
• Information provided by (Responsible Party): University of Waterloo

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Glaucoma; Dry Eyes	Drug: Refresh Tears Lubricant Eye Drops (Allergan)	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Study on the Use of Artificial Tears to Treat Dry Eye in Glaucoma Patients
• Study Start Date: August 2012
• Actual Primary Completion Date: April 2013
• Actual Study Completion Date: April 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Refresh Tears Lubricant Eye Drops (Allergan); Artificial tears eye drops QID for 1 month	Drug: Refresh Tears Lubricant Eye Drops (Allergan); Eye drops QID for 1 month

Outcome Measures

Primary Outcome Measures :

1. Ocular Surface Staining [ Time Frame: At baseline (dispensing visit) ]
   Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence
2. Ocular Surface Staining [ Time Frame: After 1 week ]
   Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence
3. Ocular Surface Staining [ Time Frame: After 1 month ]
   Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence
4. Tear Break up Time With Fluorescein [ Time Frame: At baseline (dispensing visit) ]
   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 .
5. Tear Break up Time With Fluorescein [ Time Frame: After 1 week ]
   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 .
6. Tear Break up Time With Fluorescein [ Time Frame: After 1 month ]
   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 .

Secondary Outcome Measures :

1. Ocular Surface Disease Index (OSDI) Score [ Time Frame: At baseline (dispensing visit) ]
   The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score).
2. Ocular Surface Disease Index (OSDI) Score [ Time Frame: 1 week after using artificial tears ]
   The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score).
3. Ocular Surface Disease Index (OSDI) Score [ Time Frame: 1 month after using artificial tears ]
   The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worse possible score).

Other Outcome Measures:

1. Subjective Ratings of Comfort [ Time Frame: At baseline (dispensing visit) ]
   Participants completed a standardized grading scale regarding their subjective ratings of comfort (0 = very poor comfort, 100=excellent comfort)
2. Subjective Ratings of Comfort [ Time Frame: 1 week after using artificial tears ]
   Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0= very poor comfort, 100=excellent comfort)
3. Subjective Ratings of Comfort [ Time Frame: 1 month after using artificial tears ]
   Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0=very poor comfort, 0 = excellent comfort)

Eligibility Criteria

• Ages Eligible for Study: 17 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Canada, Ontario

Centre for Contact Lens Research, University of Waterloo

Waterloo, Ontario, Canada, N2L 3G1

Sponsors and Collaborators

University of Waterloo

Allergan

Investigators

• Principal Investigator: Lyndon Jones, PhD; University of Waterloo

More Information

• Responsible Party: University of Waterloo
• ClinicalTrials.gov Identifier: NCT01682460
• Other Study ID Numbers: 18262
• First Posted: September 11, 2012
• Results First Posted: July 3, 2014
• Last Update Posted: June 5, 2017
• Last Verified: May 2017

Additional relevant MeSH terms:

Glaucoma; Keratoconjunctivitis Sicca; Dry Eye Syndromes; Ocular Hypertension; Eye Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Lacrimal Apparatus Diseases; Ophthalmic Solutions; Lubricant Eye Drops; Pharmaceutical Solutions