A Study of AL38583 Ophthalmic Solution 0.05%, 0.010% Versus AL38583 Vehicle for Dry Eye

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00893139
First received: May 4, 2009
Last updated: August 11, 2010
Last verified: August 2010
  Purpose

The purpose of this study is to determine whether AL38583 Ophthalmic solution is effective for treatment of signs and symptoms of dry eye.


Condition Intervention Phase
Dry Eye
Drug: AL38583 Ophthalmic Solution 0.05%
Drug: AL38583 Ophthalmic Solution 0.10%
Drug: AL38583 Ophthalmic Solution Vehical
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:
  • Change from baseline in sodium fluorescein corneal staining score [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in the phenol red thread length [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 750
Study Start Date: June 2009
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
AL38583 Ophthalmic Solution 0.05%
Drug: AL38583 Ophthalmic Solution 0.05%
Topical
Active Comparator: 2
AL38583 Ophthalmic Solution 0.10%
Drug: AL38583 Ophthalmic Solution 0.10%
Topical
Placebo Comparator: 3
Vehicle
Drug: AL38583 Ophthalmic Solution Vehical
Topical

  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

Exclusion Criteria:

  • Any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude the safe administration of testarticle or safe participation in this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00893139

Locations
United States, Texas
Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Ravaughn Williams, OD, MS Study Manager, External Disease, Alcon Research
ClinicalTrials.gov Identifier: NCT00893139     History of Changes
Other Study ID Numbers: C-08-077
Study First Received: May 4, 2009
Last Updated: August 11, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
Dry Eye

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on April 23, 2014