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

This study has been completed.
Information provided by (Responsible Party):
Alcon Research Identifier:
First received: May 4, 2009
Last updated: July 11, 2014
Last verified: July 2014
The purpose of this study is to determine whether AL-38583 ophthalmic solution is effective for treatment of signs and symptoms of dry eye.

Condition Intervention Phase
Dry Eye
Drug: AL-38583 ophthalmic solution 0.05%
Drug: AL-38583 ophthalmic solution 0.10%
Drug: AL-38583 vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean change from baseline in sodium fluorescein corneal staining score [ Time Frame: Baseline, up to Day 35 ]

Secondary Outcome Measures:
  • Mean change from baseline in phenol red thread length [ Time Frame: Baseline, up to Day 35 ]

Enrollment: 765
Study Start Date: June 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AL-38583 0.05%
AL-38583 ophthalmic solution 0.05%, 1 drop per eye, 3 times a day, for 35 days
Drug: AL-38583 ophthalmic solution 0.05%
Experimental: AL-38583 0.10%
AL-38583 ophthalmic solution 0.10%, 1 drop per eye, 3 times a day, for 35 days
Drug: AL-38583 ophthalmic solution 0.10%
Placebo Comparator: AL-38583 vehicle
Inactive ingredients used as a placebo comparator, 1 drop per eye, 3 times a day, for 35 days
Drug: AL-38583 vehicle
Inactive ingredients used as a placebo comparator


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00893139

Sponsors and Collaborators
Alcon Research
Study Director: Ravaughn Williams, OD, MS Alcon Research
  More Information

Responsible Party: Alcon Research Identifier: NCT00893139     History of Changes
Other Study ID Numbers: C-08-077
Study First Received: May 4, 2009
Last Updated: July 11, 2014

Keywords provided by Alcon Research:
Dry Eye

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions processed this record on April 26, 2017