AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation

July 15, 2014 updated by: Alcon Research
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

312

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AL-38583 0.01%
AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks
Drug: AL-38583 ophthalmic solution
Experimental: AL-38583 0.05%
AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks
Drug: AL-38583 ophthalmic solution
Experimental: AL-38583 0.2%
AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks
Drug: AL-38583 ophthalmic solution
Placebo Comparator: AL-38583 Vehicle
AL-38583 ophthalmic solution vehicle, 1 drop instilled in each eye 3 times per day for 2 weeks
Drug: AL-38583 ophthalmic solution vehicle
Inactive ingredients used as a placebo comparator
Active Comparator: MAXIDEX
Dexamethasone ophthalmic suspension, 0.1%, 1 drop instilled in each eye 3 times per day for 2 weeks
Drug: Dexamethasone ophthalmic suspension, 0.1%
Other Names:
  • MAXIDEX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean area under the curve 0-7 hours post-CAC for conjunctival redness scores
Time Frame: Day 14
Day 14

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean daily diary ocular redness scores
Time Frame: 2 week period between Day 0 and Day 14
2 week period between Day 0 and Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Collaborators

Ophthalmic Research Associates, Inc.

Investigators

  • Study Director: Michela Palmer, Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

October 22, 2009

First Submitted That Met QC Criteria

October 22, 2009

First Posted (Estimate)

October 23, 2009

Study Record Updates

Last Update Posted (Estimate)

July 17, 2014

Last Update Submitted That Met QC Criteria

July 15, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-09-034

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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