Phase 2 N=154 Randomized Quadruple-blind Treatment

A Study of ADX-102 in Subjects With Allergic Conjunctivitis

Conjunctivitis, Allergic

Bottom Line

View on ClinicalTrials.gov: NCT03012165 ↗

Enrolled (actual)

154

Serious AEs

0.0%

Results posted

Jan 2023

Primary outcome: Primary: Ocular Itching Evaluated by the Subject at 10(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15. — 2.020; 2.398; 2.515 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ADX-102 Ophthalmic Drops (0.5%) (Drug); ADX-102 Ophthalmic Drops (0.1%) (Drug); Vehicle of ADX-102 Ophthalmic Drops (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Aldeyra Therapeutics, Inc.
Primary completion: May 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Ocular Itching Evaluated by the Subject at 10(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.	2.020; 2.398; 2.515	—
PRIMARY Ocular Itching Evaluated by the Subject at 15(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.	1.662; 1.801; 1.985	—
PRIMARY Ocular Itching Evaluated by the Subject at 20(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.	1.152; 1.434; 1.551	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03012165). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.