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

Glaucoma Clinical Trial

— IVES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01682460
• Other study ID #: 18262
• Status: Completed
• Phase: Phase 4
• First received: August 29, 2012
• Last updated: July 2, 2014
• Start date: August 2012
• Est. completion date: April 2013

Study information

• Verified date: July 2014
• Source: University of Waterloo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Dry Eyes
• Glaucoma
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Refresh Tears Lubricant Eye Drops (Allergan)
Eye drops QID for 1 month

Locations

Country	Name	City	State
Canada	Centre for Contact Lens Research, University of Waterloo	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Waterloo	Allergan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subjective Ratings of Comfort	Participants completed a standardized grading scale regarding their subjective ratings of comfort (0 = very poor comfort, 100=excellent comfort)	At baseline (dispensing visit)	No
Other	Subjective Ratings of Comfort	Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0= very poor comfort, 100=excellent comfort)	1 week after using artificial tears	No
Other	Subjective Ratings of Comfort	Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0=very poor comfort, 0 = excellent comfort)	1 month after using artificial tears	No
Primary	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)	No
Primary	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	No
Primary	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	No
Primary	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)	No
Primary	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	No
Primary	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	No
Secondary	Ocular Surface Disease Index (OSDI) Score	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 to 100.	At baseline (dispensing visit)	No
Secondary	Ocular Surface Disease Index (OSDI) Score	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 to 100.	1 week after using artificial tears	No
Secondary	Ocular Surface Disease Index (OSDI) Score	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 to 100.	1 month after using artificial tears	No