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

Dry Eye Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00893139
• Other study ID #: C-08-077
• Status: Completed
• Phase: Phase 2
• First received: May 4, 2009
• Last updated: July 11, 2014
• Start date: June 2009
• Est. completion date: January 2010

Study information

• Verified date: July 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 765
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• AL-38583 ophthalmic solution 0.05%

• AL-38583 ophthalmic solution 0.10%

• AL-38583 vehicle
Inactive ingredients used as a placebo comparator

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in sodium fluorescein corneal staining score		Baseline, up to Day 35	No
Secondary	Mean change from baseline in phenol red thread length		Baseline, up to Day 35	No