CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 154 enrolled
Drug / intervention
ADX-102 Ophthalmic Drops (0.5%) +2 moredrug
Likely dose
ADX-102 ophthalmic drops 0.5% or 0.1% administered twice in two weeksAI-extracted
Key inclusion· 3
  • Age ≥18 years, either gender, any race
  • Positive history of ocular allergies with documented positive skin test reaction to seasonal (grasses, ragweed, trees) or perennial allergen (cat/dog dander, dust mites, cockroach) within past 24 months
  • Visual acuity ≥0.7 logMAR or better in each eye on ETDRS chart
Key exclusion· 6
  • Known contraindications or sensitivities to investigational product or its components
  • Ocular conditions that could affect safety or trial parameters: narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium, or dry eye
  • Ocular surgical intervention within 3 months prior to Visit 1 or during study; refractive surgery within past 6 months
  • History of retinal detachment, diabetic retinopathy, or active retinal disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03012165
NCT03012165Phase 2Completed

A Study of ADX-102 in Subjects With Allergic Conjunctivitis

Aldeyra Therapeutics, Inc.·interventional·Posted Jan 6, 2017·Updated Jan 9, 2023

In Brief

A Phase 2 clinical trial evaluating ADX-102 Ophthalmic Drops (0.5%), ADX-102 Ophthalmic Drops (0.1%), and 1 other intervention for Conjunctivitis, Allergic. Completed, enrolled 154 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsORA, Inc.

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 6, 2017
Enrollment StartDec 1, 2016
Primary CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 9.5 years ago

Interventions

ADX-102 Ophthalmic Drops (0.5%)drug

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

ADX-102 Ophthalmic Drops (0.1%)drug

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

Vehicle of ADX-102 Ophthalmic Dropsdrug

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