A Study of ADX-102 in Subjects With Allergic Conjunctivitis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Conjunctivitis, Allergic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ADX-102 Ophthalmic Drops (0.5%)

ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.

Group Type EXPERIMENTAL

ADX-102 Ophthalmic Drops (0.5%)

Intervention Type DRUG

ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.

ADX-102 Ophthalmic Drops (0.1%)

ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.

Group Type EXPERIMENTAL

ADX-102 Ophthalmic Drops (0.1%)

Intervention Type DRUG

ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.

Vehicle of ADX-102 Ophthalmic Drops

Group Type PLACEBO_COMPARATOR

Vehicle of ADX-102 Ophthalmic Drops

Intervention Type DRUG

Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks.

Interventions

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ADX-102 Ophthalmic Drops (0.5%)

ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.

Intervention Type DRUG

ADX-102 Ophthalmic Drops (0.1%)

ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.

Intervention Type DRUG

Vehicle of ADX-102 Ophthalmic Drops

Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No