Back to resultsAL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AL-38583 ophthalmic solution
AL-38583 ophthalmic solution vehicle
Dexamethasone ophthalmic suspension, 0.1%
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis focused on measuring Conjunctivitis, conjunctival inflammation, ocular allergies
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Active Comparator
Arm Label
AL-38583 0.01%
AL-38583 0.05%
AL-38583 0.2%
AL-38583 Vehicle
MAXIDEX
Arm Description
AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks
AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks
AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks
AL-38583 ophthalmic solution vehicle, 1 drop instilled in each eye 3 times per day for 2 weeks
Dexamethasone ophthalmic suspension, 0.1%, 1 drop instilled in each eye 3 times per day for 2 weeks
Outcomes
Primary Outcome Measures
Mean area under the curve 0-7 hours post-CAC for conjunctival redness scores
Secondary Outcome Measures
Mean daily diary ocular redness scores
Full Information
NCT ID
NCT01001091
First Posted
October 22, 2009
Last Updated
July 15, 2014
Sponsor
Alcon Research
Collaborators
Ophthalmic Research Associates, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01001091
Brief Title
AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
Collaborators
Ophthalmic Research Associates, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
Keywords
Conjunctivitis, conjunctival inflammation, ocular allergies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
312 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AL-38583 0.01%
Arm Type
Experimental
Arm Description
AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks
Arm Title
AL-38583 0.05%
Arm Type
Experimental
Arm Description
AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks
Arm Title
AL-38583 0.2%
Arm Type
Experimental
Arm Description
AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks
Arm Title
AL-38583 Vehicle
Arm Type
Placebo Comparator
Arm Description
AL-38583 ophthalmic solution vehicle, 1 drop instilled in each eye 3 times per day for 2 weeks
Arm Title
MAXIDEX
Arm Type
Active Comparator
Arm Description
Dexamethasone ophthalmic suspension, 0.1%, 1 drop instilled in each eye 3 times per day for 2 weeks
Intervention Type
Drug
Intervention Name(s)
AL-38583 ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
AL-38583 ophthalmic solution vehicle
Intervention Description
Inactive ingredients used as a placebo comparator
Intervention Type
Drug
Intervention Name(s)
Dexamethasone ophthalmic suspension, 0.1%
Other Intervention Name(s)
MAXIDEX
Primary Outcome Measure Information:
Title
Mean area under the curve 0-7 hours post-CAC for conjunctival redness scores
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
Mean daily diary ocular redness scores
Time Frame
2 week period between Day 0 and Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michela Palmer
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation
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