A Methodology Development Environmental Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis

Phase 1

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: Reproxalap Ophthalmic Solution (0.5%); Drug: Reproxalap Ophthalmic Solution (0.25%); Drug: Vehicle Ophthalmic Solution

• Registration Number: NCT03660878
• Lead Sponsor: Aldeyra Therapeutics, Inc.

Brief Summary

A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Methodology Development Environmental Clinical Trial with Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects with Seasonal Allergic Conjunctivitis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-31
• Study First Submitted QC: 2018-09-04
• Study First Posted: 2018-09-07
• Study Start: 2018-09-08
• Primary Completion: 2019-11-19
• Study Completion: 2019-11-19
• Disposition First Submitted: 2020-12-02
• Disposition First Submitted QC: 2020-12-02
• Last Update Submitted: 2020-12-02
• Disposition First Posted: 2020-12-07
• Last Update Posted: 2020-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• be at least 18 years of age of either gender and any race
• have a positive history of ocular allergies and a positive skin test reaction to ragweed pollen as confirmed by the allergic skin test given to the subject within 24 months of the subject's Visit 1
• have a calculated visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart

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Exclusion Criteria

• have known contraindications or sensitivities to the use of any of the investigational product medication or components
• have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium, or a diagnosis of dry eye)
• have had ocular surgical intervention within three months prior to Visit 1, or during the trial, or a history of refractive surgery six months prior to Visit 1, or have systemic surgery planned during the clinical trial or within 30 days after;
• have a known history of retinal detachment, diabetic retinopathy, or active retinal disease
• have an active ocular infection (bacterial, viral or fungal), active uveitis, or positive history of an ocular herpetic infection at any visit;
• be a female who is currently pregnant, planning a pregnancy, or lactating

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reproxalap Ophthalmic Solution (0.5%)	Reproxalap Ophthalmic Solution (0.5%)	-
Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.25%)	-
Vehicle Ophthalmic Solution	Vehicle Ophthalmic Solution	-

Primary Outcome Measures

Name	Time	Method
Ocular itching evaluated by the Subject, safety, and tolerability.	Efficacy assessment period (Day 1 through Day 29)	The method of assessment for this outcome is the Ora Calibra(TM) Conjunctival Allergen Challenge Ocular Itching Scale.

Secondary Outcome Measures

Name	Time	Method
Adverse event assessment.	Safety assessment period (Day 1 through Day 29)	Collection of adverse events.

Trial Locations

Locations (1)

Slade & Baker Vision; 🇺🇸 Houston, Texas, United States