A Study of ADX-102 in Subjects With Allergic Conjunctivitis

Phase 2

Completed

• Conditions: Conjunctivitis, Allergic
• Interventions: Drug: ADX-102 Ophthalmic Drops (0.5%); Drug: Vehicle of ADX-102 Ophthalmic Drops; Drug: ADX-102 Ophthalmic Drops (0.1%)

• Registration Number: NCT03012165
• Lead Sponsor: Aldeyra Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-14
• Study First Submitted QC: 2017-01-04
• Study First Posted: 2017-01-06
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Disposition First Submitted: 2018-04-06
• Disposition First Submitted QC: 2018-04-06
• Disposition First Posted: 2018-04-10
• Results First Submitted: 2022-11-17
• Status Verified: 2022-12
• Results First Submitted QC: 2022-12-14
• Last Update Submitted: 2022-12-14
• Results First Posted: 2023-01-09
• Last Update Posted: 2023-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ADX-102 Ophthalmic Drops (0.5%)	ADX-102 Ophthalmic Drops (0.5%)	ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.
Vehicle of ADX-102 Ophthalmic Drops	Vehicle of ADX-102 Ophthalmic Drops	Vehicle of ADX-102 Ophthalmic Drops
ADX-102 Ophthalmic Drops (0.1%)	ADX-102 Ophthalmic Drops (0.1%)	ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.

Primary Outcome Measures

Name	Time	Method
Ocular Itching Evaluated by the Subject at 15(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.	Efficacy assessment period (Day 1 through Day 15), Day 15 reported.	Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.
Ocular Itching Evaluated by the Subject at 20(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.	Efficacy assessment period (Day 1 through Day 15), Day 15 reported.	Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.
Ocular Itching Evaluated by the Subject at 10(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.	Efficacy assessment period (Day 1 through Day 15), Day 15 reported.	Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.

Trial Locations

Locations (5)

Eye Care Centers Management; 🇺🇸 Morrow, Georgia, United States

Silverstein Eye Centers; 🇺🇸 Kansas City, Missouri, United States

Apex Eye Clinical Research; 🇺🇸 Mason, Ohio, United States

Philadelphia Eye Associates; 🇺🇸 Philadelphia, Pennsylvania, United States

Total Eye Care; 🇺🇸 Memphis, Tennessee, United States