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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.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00893139
First received: May 4, 2009
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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 (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change from baseline in phenol red thread length [ Time Frame: Baseline, up to Day 35 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893139

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00893139     History of Changes
Other Study ID Numbers: C-08-077
Study First Received: May 4, 2009
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alcon Research:
Dry Eye

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Conjunctival Diseases
Conjunctivitis
Corneal Diseases
Eye Diseases
Keratitis
Keratoconjunctivitis
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014