Back to resultsA Study of AL-38583 Ophthalmic Solution 0.05%, 0.010% Versus AL-38583 Vehicle for Dry Eye
Primary Purpose
Dry Eye
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AL-38583 ophthalmic solution 0.05%
AL-38583 ophthalmic solution 0.10%
AL-38583 vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye focused on measuring Dry Eye
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
AL-38583 0.05%
AL-38583 0.10%
AL-38583 vehicle
Arm Description
AL-38583 ophthalmic solution 0.05%, 1 drop per eye, 3 times a day, for 35 days
AL-38583 ophthalmic solution 0.10%, 1 drop per eye, 3 times a day, for 35 days
Inactive ingredients used as a placebo comparator, 1 drop per eye, 3 times a day, for 35 days
Outcomes
Primary Outcome Measures
Mean change from baseline in sodium fluorescein corneal staining score
Secondary Outcome Measures
Mean change from baseline in phenol red thread length
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00893139
Brief Title
A Study of AL-38583 Ophthalmic Solution 0.05%, 0.010% Versus AL-38583 Vehicle for Dry Eye
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether AL-38583 ophthalmic solution is effective for treatment of signs and symptoms of dry eye.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
765 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AL-38583 0.05%
Arm Type
Experimental
Arm Description
AL-38583 ophthalmic solution 0.05%, 1 drop per eye, 3 times a day, for 35 days
Arm Title
AL-38583 0.10%
Arm Type
Experimental
Arm Description
AL-38583 ophthalmic solution 0.10%, 1 drop per eye, 3 times a day, for 35 days
Arm Title
AL-38583 vehicle
Arm Type
Placebo Comparator
Arm Description
Inactive ingredients used as a placebo comparator, 1 drop per eye, 3 times a day, for 35 days
Intervention Type
Drug
Intervention Name(s)
AL-38583 ophthalmic solution 0.05%
Intervention Type
Drug
Intervention Name(s)
AL-38583 ophthalmic solution 0.10%
Intervention Type
Drug
Intervention Name(s)
AL-38583 vehicle
Intervention Description
Inactive ingredients used as a placebo comparator
Primary Outcome Measure Information:
Title
Mean change from baseline in sodium fluorescein corneal staining score
Time Frame
Baseline, up to Day 35
Secondary Outcome Measure Information:
Title
Mean change from baseline in phenol red thread length
Time Frame
Baseline, up to Day 35
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ravaughn Williams, OD, MS
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study of AL-38583 Ophthalmic Solution 0.05%, 0.010% Versus AL-38583 Vehicle for Dry Eye
We'll reach out to this number within 24 hrs