- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02280473
A Safety and Efficacy Study of Refresh Optive® Gel Drops in Patients With Dry Eye Disease
April 9, 2019 updated by: Allergan
This study will evaluate the safety and efficacy o fRefresh Optive® Gel Drops in patients with dry eye disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
188
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Petaluma, California, United States, 94954
- North Bay Eye Associates
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San Diego, California, United States, 92123
- Eric M. White, OD, Inc.
-
-
Maine
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Bangor, Maine, United States, 04401
- Eye Center Northeast
-
-
Missouri
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Kansas City, Missouri, United States, 64154
- Moyes Eye Center, PC
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Saint Louis, Missouri, United States, 63131
- Ophthalmology Associates
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Washington, Missouri, United States, 63090
- Comprehensive Eye Care, Ltd.
-
-
New York
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Rochester, New York, United States, 14618
- Rochester Ophthalmological Group, PC
-
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Rhode Island
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Warwick, Rhode Island, United States, 02888
- David W. Ferris & Associates, Inc.
-
-
Tennessee
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Brentwood, Tennessee, United States, 37027
- Primary Eyecare Group, PC
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Memphis, Tennessee, United States, 38104
- The Eye Center at Southern College of Optometry
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Current use of an artificial tear product
- Visual acuity of at least 20/32 (while wearing glasses, if necessary).
Exclusion Criteria:
- Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study
- Cataract surgery, laser-assisted in situ keratomileusis [LASIK], or photorefractive keratectomy, within the last 6 months
- Current eye infection or inflammation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Refresh Optive® Gel Drops
Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
Active Comparator: REFRESH LIQUIGEL®
REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score
Time Frame: Baseline, Day 30
|
The OSDI is a 12-question survey for patients to document their dry eye disease symptoms.
The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability.
The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability).
A negative number change from baseline represents an improvement.
|
Baseline, Day 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in the OSDI© Score
Time Frame: Baseline, Day 7
|
The OSDI is a 12-question survey for patients to document their dry eye disease symptoms.
The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability.
The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability).
A negative number change from baseline represents an improvement.
|
Baseline, Day 7
|
Change From Baseline in Tear Break-up Time (TBUT)
Time Frame: Baseline, Day 30
|
TBUT is the time required for dry spots to appear on the surface of the eye after blinking.
The longer it takes, the more stable the tear film.
A short TBUT is a sign of poor tear film.
A positive number change from baseline indicates an increase in TBUT (improvement).
The eye with shorter average TBUT at baseline is reported for each patient.
|
Baseline, Day 30
|
Change From Baseline in the Combined Corneal and Conjunctival Staining Scores
Time Frame: Baseline, Day 30
|
The cornea is the transparent front part of the eye which covers the iris and pupil.
The conjunctiva is the clear membrane covering the white surface of the eye.
The cornea is divided into 5 zones and the nasal and temporal conjunctiva is divided into 6 zones.
The combined staining score is based on the sum of the five zones on the cornea and the six zones on the conjunctiva.
Each zone is graded on a 0-5 scale (0=None; 1=trace; 2=mild; 3=moderate; 4=severe; 5=very severe), for a total score ranging from 0-55.
The higher the score, the worse the dry eye condition.
A negative number change from baseline represents a decrease in the severity of staining (improvement).
The eye with higher score at baseline is reported for each subject.
|
Baseline, Day 30
|
Change From Baseline in the Schirmer Test
Time Frame: Baseline, Day 30
|
The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes.
The results indicate the presence of dry eye.
The eye with the lower value at Baseline was used for Analysis.
Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears..
The smaller the number, the more severe the dry eye.
A positive number change from Baseline indicates improvement.
The eye with the lower value at baseline is used for each subject.
|
Baseline, Day 30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 13, 2014
Primary Completion (Actual)
March 16, 2015
Study Completion (Actual)
March 16, 2015
Study Registration Dates
First Submitted
October 29, 2014
First Submitted That Met QC Criteria
October 29, 2014
First Posted (Estimate)
October 31, 2014
Study Record Updates
Last Update Posted (Actual)
April 16, 2019
Last Update Submitted That Met QC Criteria
April 9, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11193X-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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