ADX-102-AC-004

ADX-102-AC-004

A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Phase 2b Evaluation of the Onset and Duration of ADX-102 Ophthalmic Drops (0.5% and 0.1%) Compared to Vehicle of ADX-102 Ophthalmic Drops in the Conjunctival Allergen Challenge (Ora-CAC®) Model of Acute Allergic Conjunctivitis.

2016-12-01

2017-05-01

2017-05-01

Completed

Early phase I

154

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 (grasses, ragweed, and/or trees) or perennial allergen (cat dander, dog dander, dust mites, cockroach) as confirmed by an allergic skin test 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 study and/or a history of refractive surgery within the past six (6) months * 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 study duration and for 14 days prior to the installation of investigational product, or has a positive urine pregnancy test at Visit 1

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 154, 'type': 'ACTUAL'}}

2023-01-09