AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation

Phase 2

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: AL-38583 ophthalmic solution; Drug: Dexamethasone ophthalmic suspension, 0.1%; Drug: AL-38583 ophthalmic solution vehicle

• Registration Number: NCT01001091
• Lead Sponsor: Alcon Research

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2009-10-22
• Study First Submitted QC: 2009-10-22
• Study First Posted: 2009-10-23
• Study Start: 2009-12
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2014-07
• Disposition First Submitted: 2014-07-15
• Disposition First Submitted QC: 2014-07-15
• Last Update Submitted: 2014-07-15
• Disposition First Posted: 2014-07-17
• Last Update Posted: 2014-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 312

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AL-38583 0.2%	AL-38583 ophthalmic solution	AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks
AL-38583 0.01%	AL-38583 ophthalmic solution	AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks
MAXIDEX	Dexamethasone ophthalmic suspension, 0.1%	Dexamethasone ophthalmic suspension, 0.1%, 1 drop instilled in each eye 3 times per day for 2 weeks
AL-38583 0.05%	AL-38583 ophthalmic solution	AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks
AL-38583 Vehicle	AL-38583 ophthalmic solution vehicle	AL-38583 ophthalmic solution vehicle, 1 drop instilled in each eye 3 times per day for 2 weeks

Primary Outcome Measures

Name	Time	Method
Mean area under the curve 0-7 hours post-CAC for conjunctival redness scores	Day 14

Secondary Outcome Measures

Name	Time	Method
Mean daily diary ocular redness scores	2 week period between Day 0 and Day 14