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

• Sponsor: University of Waterloo (Other)
• Overall Status: Completed
• CT.gov ID: NCT01682460
• Collaborator: Allergan (Industry)
• Enrollment: 15
• Location: 1
• Arm: 1
• Duration (Months): 8
• Patients Per Site Per Month: 1.9

Study Details

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
• 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: Aug 1, 2012
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Apr 1, 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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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

Criteria

• Ages Eligible for Study: 17 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Waterloo
• ClinicalTrials.gov Identifier: NCT01682460
• Other Study ID Numbers: 18262
• First Posted: Sep 11, 2012
• Last Update Posted: Jun 5, 2017
• Last Verified: May 1, 2017

• Additional relevant MeSH terms: Glaucoma; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Ophthalmic Solutions; Lubricant Eye Drops

Study Results

Participant Flow

Arm/Group Title	Refresh Tears Lubricant Eye Drops (Allergan)
Arm/Group Description	Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Period Title: Overall Study
STARTED	15
COMPLETED	11
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Refresh Tears Lubricant Eye Drops (Allergan)
Arm/Group Description	Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Overall Participants	11
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68 (5)
Sex: Female, Male (Count of Participants)
Female	9 81.8%
Male	2 18.2%
Region of Enrollment (participants) [Number]
Canada	11 100%

Outcome Measures

1. Primary Outcome

Title	Ocular Surface Staining
Description	Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence
Time Frame	At baseline (dispensing visit)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Refresh Tears Lubricant Eye Drops (Allergan)
Arm/Group Description	Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Measure Participants	11
Mean (Standard Deviation) [units on a scale]	1.65 (0.80)

2. Primary Outcome

Title	Ocular Surface Staining
Description	Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence
Time Frame	After 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Refresh Tears Lubricant Eye Drops (Allergan)
Arm/Group Description	Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Measure Participants	11
Mean (Standard Deviation) [units on a scale]	1.55 (0.88)

3. Primary Outcome

Title	Ocular Surface Staining
Description	Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence
Time Frame	After 1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Refresh Tears Lubricant Eye Drops (Allergan)
Arm/Group Description	Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Measure Participants	11
Mean (Standard Deviation) [units on a scale]	1.29 (0.89)

4. Primary Outcome

Title	Tear Break up Time With Fluorescein
Description	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 .
Time Frame	At baseline (dispensing visit)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Refresh Tears Lubricant Eye Drops (Allergan)
Arm/Group Description	Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Measure Participants	11
Mean (Standard Deviation) [seconds]	2.88 (2.01)

5. Primary Outcome

Title	Tear Break up Time With Fluorescein
Description	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 .
Time Frame	After 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Refresh Tears Lubricant Eye Drops (Allergan)
Arm/Group Description	Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Measure Participants	11
Mean (Standard Deviation) [seconds]	3.41 (2.29)

6. Primary Outcome

Title	Tear Break up Time With Fluorescein
Description	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 .
Time Frame	After 1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Refresh Tears Lubricant Eye Drops (Allergan)
Arm/Group Description	Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Measure Participants	11
Mean (Standard Deviation) [seconds]	4.01 (2.76)

7. Secondary Outcome

Title	Ocular Surface Disease Index (OSDI) Score
Description	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).
Time Frame	At baseline (dispensing visit)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Refresh Tears Lubricant Eye Drops (Allergan)
Arm/Group Description	Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Measure Participants	11
Mean (Standard Deviation) [units on a scale]	25 (16)

8. Other Pre-specified Outcome

Title	Subjective Ratings of Comfort
Description	Participants completed a standardized grading scale regarding their subjective ratings of comfort (0 = very poor comfort, 100=excellent comfort)
Time Frame	At baseline (dispensing visit)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Refresh Tears Lubricant Eye Drops (Allergan)
Arm/Group Description	Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Measure Participants	11
Mean (Standard Deviation) [units on a scale]	80 (14)

9. Secondary Outcome

Title	Ocular Surface Disease Index (OSDI) Score
Description	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).
Time Frame	1 week after using artificial tears

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Refresh Tears Lubricant Eye Drops (Allergan)
Arm/Group Description	Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Measure Participants	11
Mean (Standard Deviation) [units on a scale]	18 (11)

10. Secondary Outcome

Title	Ocular Surface Disease Index (OSDI) Score
Description	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).
Time Frame	1 month after using artificial tears

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Refresh Tears Lubricant Eye Drops (Allergan)
Arm/Group Description	Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Measure Participants	11
Mean (Standard Deviation) [units on a scale]	15 (13)

11. Other Pre-specified Outcome

Title	Subjective Ratings of Comfort
Description	Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0= very poor comfort, 100=excellent comfort)
Time Frame	1 week after using artificial tears

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Refresh Tears Lubricant Eye Drops (Allergan)
Arm/Group Description	Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Measure Participants	11
Mean (Standard Deviation) [units on a scale]	92 (8)

12. Other Pre-specified Outcome

Title	Subjective Ratings of Comfort
Description	Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0=very poor comfort, 0 = excellent comfort)
Time Frame	1 month after using artificial tears

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Refresh Tears Lubricant Eye Drops (Allergan)
Arm/Group Description	Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Measure Participants	11
Mean (Standard Deviation) [units on a scale]	92 (7)

Adverse Events

Arm/Group Title	Refresh Tears Lubricant Eye Drops (Allergan)
Arm/Group Description	Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
All Cause Mortality
	Refresh Tears Lubricant Eye Drops (Allergan)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Refresh Tears Lubricant Eye Drops (Allergan)
	Affected / at Risk (%)	# Events
Total	0/11 (0%)
Other (Not Including Serious) Adverse Events
	Refresh Tears Lubricant Eye Drops (Allergan)
	Affected / at Risk (%)	# Events
Total	1/11 (9.1%)
Eye disorders
Corneal marginal keratitis	1/11 (9.1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.