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A Study of ADX-102 in Subjects With Allergic Conjunctivitis

Primary Purpose

Conjunctivitis, Allergic

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ADX-102 Ophthalmic Drops (0.5%)
ADX-102 Ophthalmic Drops (0.1%)
Vehicle of ADX-102 Ophthalmic Drops
Sponsored by
Aldeyra Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Conjunctivitis, Allergic focused on measuring ADX-102, Allergic Conjunctivitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eye Care Centers Management
  • Silverstein Eye Centers
  • Apex Eye Clinical Research
  • Philadelphia Eye Associates
  • Total Eye Care

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

ADX-102 Ophthalmic Drops (0.5%)

ADX-102 Ophthalmic Drops (0.1%)

Vehicle of ADX-102 Ophthalmic Drops

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 14, 2016
Last Updated
December 14, 2022
Sponsor
Aldeyra Therapeutics, Inc.
Collaborators
ORA, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03012165
Brief Title
A Study of ADX-102 in Subjects With Allergic Conjunctivitis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aldeyra Therapeutics, Inc.
Collaborators
ORA, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conjunctivitis, Allergic
Keywords
ADX-102, Allergic Conjunctivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ADX-102 Ophthalmic Drops (0.5%)
Arm Type
Experimental
Arm Description
ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.
Arm Title
ADX-102 Ophthalmic Drops (0.1%)
Arm Type
Experimental
Arm Description
ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.
Arm Title
Vehicle of ADX-102 Ophthalmic Drops
Arm Type
Placebo Comparator
Arm Description
Vehicle of ADX-102 Ophthalmic Drops
Intervention Type
Drug
Intervention Name(s)
ADX-102 Ophthalmic Drops (0.5%)
Intervention Description
ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.
Intervention Type
Drug
Intervention Name(s)
ADX-102 Ophthalmic Drops (0.1%)
Intervention Description
ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.
Intervention Type
Drug
Intervention Name(s)
Vehicle of ADX-102 Ophthalmic Drops
Intervention Description
Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks.
Primary Outcome Measure Information:
Title
Ocular Itching Evaluated by the Subject at 10(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
Description
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.
Time Frame
Efficacy assessment period (Day 1 through Day 15), Day 15 reported.
Title
Ocular Itching Evaluated by the Subject at 15(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
Description
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.
Time Frame
Efficacy assessment period (Day 1 through Day 15), Day 15 reported.
Title
Ocular Itching Evaluated by the Subject at 20(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
Description
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.
Time Frame
Efficacy assessment period (Day 1 through Day 15), Day 15 reported.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Eye Care Centers Management
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Silverstein Eye Centers
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Facility Name
Apex Eye Clinical Research
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Philadelphia Eye Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19148
Country
United States
Facility Name
Total Eye Care
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of ADX-102 in Subjects With Allergic Conjunctivitis

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