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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03660878
Other study ID # ADX-102-AC-010
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date September 8, 2018
Est. completion date November 19, 2019

Study information

Verified date August 2018
Source Aldeyra Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date November 19, 2019
Est. primary completion date November 19, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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

Study Design


Intervention

Drug:
Reproxalap Ophthalmic Solution (0.25%)
Reproxalap Ophthalmic Solution (0.25%) administered four times a day and an additional four times a day on an as needed basis.
Reproxalap Ophthalmic Solution (0.5%)
Reproxalap Ophthalmic Solution (0.5%) administered four times a day and an additional four times a day on an as needed basis.
Vehicle Ophthalmic Solution
Vehicle Ophthalmic Solution administered four times a day and an additional four times a day on an as needed basis.

Locations

Country Name City State
United States Slade & Baker Vision Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Aldeyra Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ocular itching evaluated by the Subject, safety, and tolerability. The method of assessment for this outcome is the Ora Calibra(TM) Conjunctival Allergen Challenge Ocular Itching Scale. Efficacy assessment period (Day 1 through Day 29)
Secondary Adverse event assessment. Collection of adverse events. Safety assessment period (Day 1 through Day 29)
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