AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation

Allergic Conjunctivitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01001091
• Other study ID #: C-09-034
• Status: Completed
• Phase: Phase 2
• First received: October 22, 2009
• Last updated: July 15, 2014
• Start date: December 2009
• Est. completion date: April 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 assess the safety and efficacy of AL-38583 in the treatment of the signs of inflammation associated with allergic conjunctivitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Presence of signs and symptoms of ocular inflammation in both eyes.

• Have a positive CAC response at Visit 1.

• Able to avoid the use of disallowed medications as well as contact lens wear for the specified period prior to Visit 1, and for the duration of the study.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Have known history or presence of persistent dry eye syndrome.

• Presence of any ophthalmic abnormality that may affect the study outcomes.

• Have a history of moderate to severe allergic asthma reaction to mountain cedar or the perennial allergens used in the 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

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• AL-38583 ophthalmic solution

• AL-38583 ophthalmic solution vehicle
Inactive ingredients used as a placebo comparator
• Dexamethasone ophthalmic suspension, 0.1%

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Alcon Research	Ophthalmic Research Associates, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean area under the curve 0-7 hours post-CAC for conjunctival redness scores		Day 14	No
Secondary	Mean daily diary ocular redness scores		2 week period between Day 0 and Day 14	No