A Study of AL-38583 Ophthalmic Solution 0.05%, 0.010% Versus AL-38583 Vehicle for Dry Eye

Phase 2

Completed

• Conditions: Dry Eye
• Interventions: Drug: AL-38583 ophthalmic solution 0.10%; Drug: AL-38583 vehicle; Drug: AL-38583 ophthalmic solution 0.05%

• Registration Number: NCT00893139
• Lead Sponsor: Alcon Research

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-04
• Study First Submitted QC: 2009-05-04
• Study First Posted: 2009-05-05
• Study Start: 2009-06
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2014-07
• Disposition First Submitted: 2014-07-11
• Disposition First Submitted QC: 2014-07-11
• Last Update Submitted: 2014-07-11
• Disposition First Posted: 2014-07-15
• Last Update Posted: 2014-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 765

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AL-38583 0.10%	AL-38583 ophthalmic solution 0.10%	AL-38583 ophthalmic solution 0.10%, 1 drop per eye, 3 times a day, for 35 days
AL-38583 vehicle	AL-38583 vehicle	Inactive ingredients used as a placebo comparator, 1 drop per eye, 3 times a day, for 35 days
AL-38583 0.05%	AL-38583 ophthalmic solution 0.05%	AL-38583 ophthalmic solution 0.05%, 1 drop per eye, 3 times a day, for 35 days

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in sodium fluorescein corneal staining score	Baseline, up to Day 35

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in phenol red thread length	Baseline, up to Day 35