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

Alcon Research765 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

765

Conditions

Dry Eye

Interventions

AL-38583 ophthalmic solution 0.05%DRUG

AL-38583 ophthalmic solution 0.10%DRUG

AL-38583 vehicleDRUG

Inactive ingredients used as a placebo comparator

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Mean change from baseline in sodium fluorescein corneal staining score

Time frame: Baseline, up to Day 35

Secondary Outcomes

Mean change from baseline in phenol red thread length

Time frame: Baseline, up to Day 35

Data from ClinicalTrials.gov

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