Safety and Efficacy Study of New Eye Drop Formulations With Refresh Tears® in Patients With Dry Eye Disease
1 other identifier
interventional
305
2 countries
2
Brief Summary
This study will investigate the safety, efficacy and acceptability of two new eye drop formulations compared with Refresh Tears® in patients with dry eye disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2011
CompletedFirst Posted
Study publicly available on registry
February 11, 2011
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 25, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 25, 2012
CompletedResults Posted
Study results publicly available
November 25, 2013
CompletedApril 16, 2019
April 1, 2019
1.4 years
February 10, 2011
September 24, 2013
April 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Ocular Surface Disease Index© (OSDI) Score
The OSDI is a questionnaire consisting of 12 questions assessing severity of dry eye using a 5-point scale where 0=none of the time to 4=all of the time. The total score is the sum of the individual scores normalized (standardized) to a severity scale of 0=no symptoms (best score) to 100=maximum severity (worst score). A negative change from Baseline indicated improvement.
Baseline, Day 90
Secondary Outcomes (7)
Change From Baseline in Visual Analog (VAS) Symptom Scale: Dryness
Baseline, Day 90
Percentage of Participants Much Better or Better in Near Visual Acuity (Low Contrast)
Baseline, Day 90
Percentage of Participants Much Better or Better in Near Visual Acuity (High Contrast)
Baseline, Day 90
Change From Baseline in Tear Break-Up Time (TBUT)
Baseline, Day 90
Change From Baseline in Corneal Staining
Baseline, Day 90
- +2 more secondary outcomes
Study Arms (3)
New Eye Drop Formulation 1
EXPERIMENTAL1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
New Eye Drop Formulation 2
EXPERIMENTAL1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
Refresh Tears®
ACTIVE COMPARATOR1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
Interventions
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
Eligibility Criteria
You may qualify if:
- Current use of an artificial tear product at least twice daily for at least 3 months, on average
- Ability/agreement to continue wearing existing spectacle correction (glasses) during study
You may not qualify if:
- Anticipated contact lens wear during study or contact lens use within 6 months
- Active ocular infection or allergy
- Use of any topical ophthalmic medications (eg, topical ophthalmic steroids, glaucoma drops) within 2 weeks
- Use of any topical cyclosporine products within 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (2)
Unknown Facility
Randwick, New South Wales, Australia
Unknown Facility
St. John's, Newfoundland and Labrador, Canada
Related Publications (1)
Simmons PA, Liu H, Carlisle-Wilcox C, Vehige JG. Efficacy and safety of two new formulations of artificial tears in subjects with dry eye disease: a 3-month, multicenter, active-controlled, randomized trial. Clin Ophthalmol. 2015 Apr 15;9:665-75. doi: 10.2147/OPTH.S78184. eCollection 2015.
PMID: 25931807BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2011
First Posted
February 11, 2011
Study Start
May 1, 2011
Primary Completion
September 25, 2012
Study Completion
September 25, 2012
Last Updated
April 16, 2019
Results First Posted
November 25, 2013
Record last verified: 2019-04