Safety, Efficacy, and Acceptability Study of an Eye Drop Formulation in Subjects With Dry Eye Disease
1 other identifier
interventional
315
1 country
1
Brief Summary
This study will evaluate the safety, efficacy, and acceptability of an eye drop formulation in subjects 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 Oct 2011
Shorter than P25 for phase_3
1 active site
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
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 24, 2011
CompletedFirst Posted
Study publicly available on registry
October 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2012
CompletedResults Posted
Study results publicly available
March 14, 2013
CompletedApril 16, 2019
April 1, 2019
5 months
October 24, 2011
February 11, 2013
April 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Ocular Surface Disease Index© Questionnaire Score
The Ocular Surface Disease Index© Questionnaire is a 12-item survey assessing the overall severity of dry eye disease per patient. Each question is rated on a 5-point scale ranging from 0=none of the time to 4=all of the time for a total possible score of 0=No disease to 100=Maximum severity of disease. A negative change from baseline indicates improvement.
Baseline, Day 30
Secondary Outcomes (4)
Change From Baseline in Tear Break-up Time
Baseline, Day 30
Change From Baseline in Corneal Staining
Baseline, Day 30
Change From Baseline in Conjunctival Staining
Baseline, Day 30
Change From Baseline in Schirmer Test Results
Baseline, Day 30
Study Arms (4)
Carboxymethylcellulose Based Eye Drop Formulation A
EXPERIMENTALCarboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
Carboxymethylcellulose Based Eye Drop Formulation B
EXPERIMENTALCarboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
Carboxymethylcellulose Preservative-Free Lubricant Eye Drops
ACTIVE COMPARATORCarboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
Carboxymethylcellulose Based Lubricant Eye Drops
ACTIVE COMPARATORCarboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
Interventions
Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
Eligibility Criteria
You may qualify if:
- Dry eyes
- Current use of eye drops for dry eye at least twice daily, on average for at least 3 months
You may not qualify if:
- Cataract, laser-assisted in situ keratomileusis (LASIK), or photorefractive keratectomy (PRK) surgery in the last 12 months
- Need to wear contact lenses during the study, or has worn contact lenses in the last 6 months
- Active ocular allergy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Unknown Facility
Petaluma, California, United States
Related Publications (1)
Simmons PA, Carlisle-Wilcox C, Vehige JG. Comparison of novel lipid-based eye drops with aqueous eye drops for dry eye: a multicenter, randomized controlled trial. Clin Ophthalmol. 2015 Apr 15;9:657-64. doi: 10.2147/OPTH.S74849. eCollection 2015.
PMID: 25931806BACKGROUND
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
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2011
First Posted
October 25, 2011
Study Start
October 1, 2011
Primary Completion
February 15, 2012
Study Completion
February 15, 2012
Last Updated
April 16, 2019
Results First Posted
March 14, 2013
Record last verified: 2019-04