Safety and Acceptability of Using a Rewetting Drop With Contact Lens Wear
1 other identifier
interventional
246
1 country
1
Brief Summary
Testing the Safety and Acceptability of Using a Rewetting Drop with Contact Lenses
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2008
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 4, 2008
CompletedFirst Posted
Study publicly available on registry
June 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
December 10, 2009
CompletedJuly 22, 2015
June 1, 2015
7 months
March 4, 2008
November 6, 2009
June 26, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Best Corrected Visual Acuity
Percentage of Subjects Tabulated by Changes in Line Number at Day 90 from Baseline; Visual Acuity measured by LogMar reported as Snellen equivalents. Better: an increase of 2 lines or more in at least one eye; No Change: a change less than +/- 2 lines in both eyes; Worse: a decrease of 2 lines or more in at least one eye.
Change from Baseline at Day 90
Secondary Outcomes (1)
Corneal Staining
Day 90
Study Arms (2)
Carboxymethylcellulose sodium and Glycerin
EXPERIMENTALCarboxymethylcellulose sodium and Glycerin based rewetting drop
Carboxymethylcellulose sodium
ACTIVE COMPARATORCarboxymethylcellulose sodium based rewetting drop
Interventions
Eye drops used at least 4 times per day, 1-2 drops in each eye while wearing contact lenses.
Eye drops used at least 4 times per day, 1-2 drops in each eye while wearing contact lenses.
Eligibility Criteria
You may qualify if:
- Adapted contact lens wearer
You may not qualify if:
- Monovision lens wearer, ocular or systemic disease, pregnant or planning to become pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Unknown Facility
San Diego, California, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Allergan, Inc.
Study Officials
- STUDY CHAIR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 4, 2008
First Posted
June 5, 2008
Study Start
March 1, 2008
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
July 22, 2015
Results First Posted
December 10, 2009
Record last verified: 2015-06