A Methodology Development Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber
Study Details
Study Description
Brief Summary
An Exploratory Clinical Trial Evaluating Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects with Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber (EEC)
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1/Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Reproxalap Ophthalmic Solution (0.25%)
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Drug: Reproxalap Ophthalmic Solution (0.25%)
Reproxalap Ophthalmic Solution (0.25%) dosed twice.
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Experimental: Reproxalap Ophthalmic Solution (0.5%)
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Drug: Reproxalap Ophthalmic Solution (0.5%)
Reproxalap Ophthalmic Solution (0.5%) dosed twice.
|
Placebo Comparator: Vehicle Ophthalmic Solution
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Drug: Vehicle Ophthalmic Solution
Vehicle Ophthalmic Solution dosed twice.
|
Outcome Measures
Primary Outcome Measures
- Ocular itching evaluated by the Subject. [Efficacy assessment period (Week 1 through Week 6).]
The method of assessment for this exploratory outcome includes the visual analog scale (VAS).
Secondary Outcome Measures
- Safety assessment. [Safety assessment period (Week 1 through week 6)]
Safety assessment as determined by collection of Adverse Events
Eligibility Criteria
Criteria
Inclusion Criteria:
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be at least 18 years of age of either gender and any race
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have at least a two-year history of moderate-to-severe ragweed-induced allergic conjunctivitis based on principal investigator's judgement
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have a positive skin prick test to ragweed pollen within the past year of screening
Exclusion Criteria:
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known contraindication or hypersensitivities to any components of the investigational product medication or components
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history of uveitis, blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis;
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presence of any ocular infection (bacterial, viral, or fungal) or active ocular inflammation (e.g., follicular conjunctivitis, allergic conjunctivitis) within 14 days prior to screening
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presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial;
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presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial
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diagnosis of moderate-to-severe pinguecula or pterygium (particularly if it results in chronic erythema), Stevens-Johnson Syndrome, ocular cicatricial pemphigoid, mucous membrane pemphigoid, significant conjunctival scarring, chemical burn, herpetic or neurotrophic keratitis, Cryopyrin Associated Periodic Syndrome (CAPS), or keratoconus
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woman of childbearing potential who is pregnant or nursing
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Inflamax Research Limited | Mississauga | Ontario | Canada | L4W 1V7/L4W 1N2 |
Sponsors and Collaborators
- Aldeyra Therapeutics, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ADX-102-AC-011