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

Alcon

Status and phase: Completed; Phase 2

Conditions: Dry Eye

Treatments: Drug: AL-38583 ophthalmic solution 0.05%; Drug: AL-38583 ophthalmic solution 0.10%; Drug: AL-38583 vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00893139

C-08-077

Details and patient eligibility

About

The purpose of this study is to determine whether AL-38583 ophthalmic solution is effective for treatment of signs and symptoms of dry eye.

Enrollment: 765 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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765 participants in 3 patient groups, including a placebo group

AL-38583 0.05%

Experimental group

Description:

AL-38583 ophthalmic solution 0.05%, 1 drop per eye, 3 times a day, for 35 days

Treatment:

Drug: AL-38583 ophthalmic solution 0.05%

AL-38583 0.10%

Experimental group

Description:

AL-38583 ophthalmic solution 0.10%, 1 drop per eye, 3 times a day, for 35 days

Treatment:

Drug: AL-38583 ophthalmic solution 0.10%

AL-38583 vehicle

Placebo Comparator group

Description:

Inactive ingredients used as a placebo comparator, 1 drop per eye, 3 times a day, for 35 days

Treatment:

Drug: AL-38583 vehicle