A Methodology Development Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber

Sponsor
Aldeyra Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03709121
Collaborator
(none)
66
1
3
5.6
11.9

Study Details

Study Description

Brief Summary

An Exploratory Clinical Trial Evaluating Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects with Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber (EEC)

Condition or Disease Intervention/Treatment Phase
  • Drug: Reproxalap Ophthalmic Solution (0.25%)
  • Drug: Reproxalap Ophthalmic Solution (0.5%)
  • Drug: Vehicle Ophthalmic Solution
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
An Exploratory Clinical Trial Evaluating Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber (EEC)
Actual Study Start Date :
Oct 2, 2018
Actual Primary Completion Date :
Mar 20, 2019
Actual Study Completion Date :
Mar 20, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Reproxalap Ophthalmic Solution (0.25%)

Drug: Reproxalap Ophthalmic Solution (0.25%)
Reproxalap Ophthalmic Solution (0.25%) dosed twice.

Experimental: Reproxalap Ophthalmic Solution (0.5%)

Drug: Reproxalap Ophthalmic Solution (0.5%)
Reproxalap Ophthalmic Solution (0.5%) dosed twice.

Placebo Comparator: Vehicle Ophthalmic Solution

Drug: Vehicle Ophthalmic Solution
Vehicle Ophthalmic Solution dosed twice.

Outcome Measures

Primary Outcome Measures

  1. Ocular itching evaluated by the Subject. [Efficacy assessment period (Week 1 through Week 6).]

    The method of assessment for this exploratory outcome includes the visual analog scale (VAS).

Secondary Outcome Measures

  1. Safety assessment. [Safety assessment period (Week 1 through week 6)]

    Safety assessment as determined by collection of Adverse Events

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 at least a two-year history of moderate-to-severe ragweed-induced allergic conjunctivitis based on principal investigator's judgement

  • have a positive skin prick test to ragweed pollen within the past year of screening

Exclusion Criteria:
  • known contraindication or hypersensitivities to any components of the investigational product medication or components

  • history of uveitis, blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis;

  • presence of any ocular infection (bacterial, viral, or fungal) or active ocular inflammation (e.g., follicular conjunctivitis, allergic conjunctivitis) within 14 days prior to screening

  • presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial;

  • presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial

  • diagnosis of moderate-to-severe pinguecula or pterygium (particularly if it results in chronic erythema), Stevens-Johnson Syndrome, ocular cicatricial pemphigoid, mucous membrane pemphigoid, significant conjunctival scarring, chemical burn, herpetic or neurotrophic keratitis, Cryopyrin Associated Periodic Syndrome (CAPS), or keratoconus

  • woman of childbearing potential who is pregnant or nursing

Contacts and Locations

Locations

Site City State Country Postal Code
1 Inflamax Research Limited Mississauga Ontario Canada L4W 1V7/L4W 1N2

Sponsors and Collaborators

  • Aldeyra Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aldeyra Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT03709121
Other Study ID Numbers:
  • ADX-102-AC-011
First Posted:
Oct 17, 2018
Last Update Posted:
May 13, 2020
Last Verified:
Oct 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Aldeyra Therapeutics, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 13, 2020