Pilot Study on the Use of Artificial Tears to Treat Dry Eye in Glaucoma Patients (IVES)
This study has been completed.
Sponsor:
University of Waterloo
Collaborator:
Allergan
Information provided by (Responsible Party):
University of Waterloo
ClinicalTrials.gov Identifier:
NCT01682460
First received: August 29, 2012
Last updated: July 2, 2014
Last verified: July 2014
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Glaucoma Dry Eyes |
Drug: Refresh Tears Lubricant Eye Drops (Allergan) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Study on the Use of Artificial Tears to Treat Dry Eye in Glaucoma Patients |
Resource links provided by NLM:
Further study details as provided by University of Waterloo:
Primary Outcome Measures:
- Ocular Surface Staining [ Time Frame: At baseline (dispensing visit) ] [ Designated as safety issue: No ]Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence
- Ocular Surface Staining [ Time Frame: After 1 week ] [ Designated as safety issue: No ]Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence
- Ocular Surface Staining [ Time Frame: After 1 month ] [ Designated as safety issue: No ]Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence
- Tear Break up Time With Fluorescein [ Time Frame: At baseline (dispensing visit) ] [ Designated as safety issue: No ]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 .
- Tear Break up Time With Fluorescein [ Time Frame: After 1 week ] [ Designated as safety issue: No ]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 .
- Tear Break up Time With Fluorescein [ Time Frame: After 1 month ] [ Designated as safety issue: No ]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:
- Ocular Surface Disease Index (OSDI) Score [ Time Frame: At baseline (dispensing visit) ] [ Designated as safety issue: No ]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.
- Ocular Surface Disease Index (OSDI) Score [ Time Frame: 1 week after using artificial tears ] [ Designated as safety issue: No ]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.
- Ocular Surface Disease Index (OSDI) Score [ Time Frame: 1 month after using artificial tears ] [ Designated as safety issue: No ]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.
Other Outcome Measures:
- Subjective Ratings of Comfort [ Time Frame: At baseline (dispensing visit) ] [ Designated as safety issue: No ]Participants completed a standardized grading scale regarding their subjective ratings of comfort (0 = very poor comfort, 100=excellent comfort)
- Subjective Ratings of Comfort [ Time Frame: 1 week after using artificial tears ] [ Designated as safety issue: No ]Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0= very poor comfort, 100=excellent comfort)
- Subjective Ratings of Comfort [ Time Frame: 1 month after using artificial tears ] [ Designated as safety issue: No ]Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0=very poor comfort, 0 = excellent comfort)
| Enrollment: | 15 |
| Study Start Date: | August 2012 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 17 Years and older (Child, Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682460
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682460
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 History of Changes |
| Other Study ID Numbers: | 18262 |
| Study First Received: | August 29, 2012 |
| Results First Received: | May 14, 2014 |
| Last Updated: | July 2, 2014 |
| Health Authority: | Canada: Ethics Review Committee Canada: Health Canada |
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 Tetrahydrozoline Lubricant Eye Drops Pharmaceutical Solutions Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Nasal Decongestants Vasoconstrictor Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on September 26, 2016