A Study of AL-38583 Ophthalmic Solution 0.05%, 0.010% Versus AL-38583 Vehicle for Dry Eye
July 11, 2014 updated by: Alcon Research
The purpose of this study is to determine whether AL-38583 ophthalmic solution is effective for treatment of signs and symptoms of dry eye.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
765
Phase
- Phase 2
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:
- Composite corneal staining score of greater than 5 in one or both eyes.
- Schirmer II score of greater than 4 mm.
- OSDI score of greater than 23.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude the safe administration of the test article or safe participation in this study.
- Other protocol-defined exclusion criteria may apply.
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: AL-38583 0.05%
AL-38583 ophthalmic solution 0.05%, 1 drop per eye, 3 times a day, for 35 days
|
|
|
Experimental: AL-38583 0.10%
AL-38583 ophthalmic solution 0.10%, 1 drop per eye, 3 times a day, for 35 days
|
|
|
Placebo Comparator: AL-38583 vehicle
Inactive ingredients used as a placebo comparator, 1 drop per eye, 3 times a day, for 35 days
|
Inactive ingredients used as a placebo comparator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mean change from baseline in sodium fluorescein corneal staining score
Time Frame: Baseline, up to Day 35
|
Baseline, up to Day 35
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mean change from baseline in phenol red thread length
Time Frame: Baseline, up to Day 35
|
Baseline, up to Day 35
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ravaughn Williams, OD, MS, Alcon Research
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
June 1, 2009
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
May 4, 2009
First Submitted That Met QC Criteria
May 4, 2009
First Posted (Estimate)
May 5, 2009
Study Record Updates
Last Update Posted (Estimate)
July 15, 2014
Last Update Submitted That Met QC Criteria
July 11, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-08-077
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.