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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00893139

Enrollment

765

Registered

2009-05-05

Start date

2009-06-30

Completion date

2010-01-31

Last updated

2014-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye

Keywords

Dry Eye

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.

Interventions

DRUGAL-38583 ophthalmic solution 0.05%

DRUGAL-38583 ophthalmic solution 0.10%

DRUGAL-38583 vehicle

Inactive ingredients used as a placebo comparator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026