Clinical trial NCT03012165: A Study of ADX-102 in Subjects With Allergic Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Conjunctivitis, Allergic
Keywords: ADX-102
Allergic Conjunctivitis
Lead sponsor: Aldeyra Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2017-01-06
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Ocular Itching Evaluated by the Subject at 10(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
timeFrame: Efficacy assessment period (Day 1 through Day 15), Day 15 reported.
measure: Ocular Itching Evaluated by the Subject at 15(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
timeFrame: Efficacy assessment period (Day 1 through Day 15), Day 15 reported.
measure: Ocular Itching Evaluated by the Subject at 20(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
timeFrame: Efficacy assessment period (Day 1 through Day 15), Day 15 reported.
Secondary outcomes:
Other outcomes:
Locations:
city: Morrow
country: United States
facility: Eye Care Centers Management
state: Georgia
city: Kansas City
country: United States
facility: Silverstein Eye Centers
state: Missouri
city: Mason
country: United States
facility: Apex Eye Clinical Research
state: Ohio
city: Philadelphia
country: United States
facility: Philadelphia Eye Associates
state: Pennsylvania
city: Memphis
country: United States
facility: Total Eye Care
state: Tennessee
Study officials:
References: