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Completed

NCT Number: NCT01001091

AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation

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.

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Key information

Conditions

Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AL-38583 ophthalmic solution

Drug

AL-38583 ophthalmic solution vehicle

Drug

Inactive ingredients used as a placebo comparator

Dexamethasone ophthalmic suspension, 0.1%

Drug

Other names: MAXIDEX

Primary outcomes

  1. Mean area under the curve 0-7 hours post-CAC for conjunctival redness scores

    Time frame: Day 14

Secondary outcomes

  1. Mean daily diary ocular redness scores

    Time frame: 2 week period between Day 0 and Day 14

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Collaborators

  • Ophthalmic Research Associates, Inc.

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 23, 2009
Registry last updated
Jul 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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