A Study of ADX-102 in Subjects With Allergic Conjunctivitis
1 other identifier
interventional
154
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2016
Shorter than P25 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 14, 2016
CompletedFirst Posted
Study publicly available on registry
January 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedResults Posted
Study results publicly available
January 9, 2023
CompletedJanuary 9, 2023
December 1, 2022
5 months
December 14, 2016
November 17, 2022
December 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Ocular Itching Evaluated by the Subject at 10(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
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.
Efficacy assessment period (Day 1 through Day 15), Day 15 reported.
Ocular Itching Evaluated by the Subject at 15(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
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.
Efficacy assessment period (Day 1 through Day 15), Day 15 reported.
Ocular Itching Evaluated by the Subject at 20(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
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.
Efficacy assessment period (Day 1 through Day 15), Day 15 reported.
Study Arms (3)
ADX-102 Ophthalmic Drops (0.5%)
EXPERIMENTALADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.
ADX-102 Ophthalmic Drops (0.1%)
EXPERIMENTALADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.
Vehicle of ADX-102 Ophthalmic Drops
PLACEBO COMPARATORVehicle of ADX-102 Ophthalmic Drops
Interventions
ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.
ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.
Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aldeyra Therapeutics, Inc.lead
- ORA, Inc.collaborator
Study Sites (5)
Eye Care Centers Management
Morrow, Georgia, 30260, United States
Silverstein Eye Centers
Kansas City, Missouri, 64133, United States
Apex Eye Clinical Research
Mason, Ohio, 45040, United States
Philadelphia Eye Associates
Philadelphia, Pennsylvania, 19148, United States
Total Eye Care
Memphis, Tennessee, 38119, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. Director, Clinical Operations
- Organization
- Aldeyra Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2016
First Posted
January 6, 2017
Study Start
December 1, 2016
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
January 9, 2023
Results First Posted
January 9, 2023
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share