A Study of ADX-102 in Subjects With Allergic Conjunctivitis

• Sponsor: Aldeyra Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03012165
• Collaborator: ORA, Inc. (Industry)
• Enrollment: 154
• Locations: 4
• Arms: 3
• Duration (Months): 5
• Patients Per Site: 38.5
• Patients Per Site Per Month: 7.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Conjunctivitis, Allergic	Drug: ADX-102 Ophthalmic Drops (0.5%); Drug: ADX-102 Ophthalmic Drops (0.1%); Drug: Vehicle of ADX-102 Ophthalmic Drops	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 154 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Dec 1, 2016
• Actual Primary Completion Date: May 1, 2017
• Actual Study Completion Date: May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ADX-102 Ophthalmic Drops (0.5%) ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.	Drug: ADX-102 Ophthalmic Drops (0.5%); ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.
Experimental: ADX-102 Ophthalmic Drops (0.1%) ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.	Drug: ADX-102 Ophthalmic Drops (0.1%); ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.
Placebo Comparator: Vehicle of ADX-102 Ophthalmic Drops Vehicle of ADX-102 Ophthalmic Drops	Drug: Vehicle of ADX-102 Ophthalmic Drops; Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks.

Outcome Measures

Primary Outcome Measures

1. Ocular itching evaluated by the Subject. [Efficacy assessment period (Day 3 through Day 15)]

   The method of assessment for this outcome is the Ora Calibra(TM) Conjunctival Allergen Challenge Ocular Itching Scale

Secondary Outcome Measures

1. Ocular redness. [Efficacy assessment period (Day 3 through Day 15)]

   The method of assessment for this outcome is the Ora Calibra(TM) Ocular Hyperemia Scale

2. Tearing [Efficacy assessment period (Day 3 through Day 15)]

   The method of assessment for this outcome is the Ora Calibra(TM) Conjunctival Allergen Challenge Tearing/Watery Eyes Scale

3. Eyelid Swelling [Efficacy assessment period (Day 3 through Day 15)]

   The method of assessment for this outcome is the Ora Calibra(TM) Conjunctival Allergen Challenge Eyelid Swelling Scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Morrow	Georgia	United States
2		Mason	Ohio	United States
3		Philadelphia	Pennsylvania	United States
4		Memphis	Tennessee	United States

Sponsors and Collaborators

• Aldeyra Therapeutics, Inc.
• ORA, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aldeyra Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT03012165
• Other Study ID Numbers: ADX-102-AC-004
• First Posted: Jan 6, 2017
• Last Update Posted: Mar 5, 2019
• Last Verified: Apr 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Aldeyra Therapeutics, Inc.: ADX-102; Allergic Conjunctivitis
• Additional relevant MeSH terms: Conjunctivitis; Conjunctivitis, Allergic; Ophthalmic Solutions

Study Results

No Results Posted as of Mar 5, 2019