A Phase 3 Study of Reproxalap in Subjects With Allergic Conjunctivitis

Description

A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions in Subjects with Acute Allergic Conjunctivitis

Study Start Date

March, 30 2018

Estimated Completion Date

December 2018

Interventions

  • Drug: Reproxalap Ophthalmic Solution (0.5%)
  • Drug: Vehicle Ophthalmic Solution
  • Drug: Reproxalap Ophthalmic Solution (0.25%)

Study ID

Aldeyra Therapeutics, Inc. -- ADX-102-AC-008

Status

Unknown

Trial ID

NCT03494504

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

300

Sponsor

Aldeyra Therapeutics, Inc.

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 a seasonal allergen (grasses, ragweed, and/or trees) as confirmed by an allergic skin test at the Screening Visit or within the past 24 months
  • 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 the investigational product or any of its 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 (3) months prior to Visit 1 or during the trial and/or a history of refractive surgery six (6) months prior to Visit 1 or have ocular or systemic surgery planned during the study or within 30 days after
  • have a known history of retinal detachment, diabetic retinopathy, or active retinal disease
  • have the presence of an active ocular infection (bacterial, viral or fungal) or positive history of an ocular herpetic infection at any visit
  • be a female who is currently pregnant, planning a pregnancy, lactating, not using a medically acceptable form of birth control throughout the trial duration, or has a positive urine pregnancy test at Visit 1

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Andover Eye Associates - Andover, Massachusetts 19.9 miles Jack V Greiner DO 617-248-3875 charlesrivereye@yahoo.com

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