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ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic Conjunctivitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03494504
Recruitment Status : Completed
First Posted : April 11, 2018
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Aldeyra Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE April 4, 2018
First Posted Date  ICMJE April 11, 2018
Last Update Posted Date November 6, 2019
Actual Study Start Date  ICMJE March 30, 2018
Actual Primary Completion Date November 5, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
Ocular itching evaluated by the Subject. [ Time Frame: Efficacy assessment period (Day -21 through Day 1) ]
The method of assessment for this outcome is the Ora Calibra(TM) Conjunctival Allergen Challenge Ocular Itching Scale
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03494504 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
Conjunctival redness [ Time Frame: Efficacy assessment period (Day -21 through Day 1) ]
The method of assessment for this outcome is the Ora Calibra(TM) Ocular Hyperemia Scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic Conjunctivitis
Official Title  ICMJE A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Phase 3 Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions (0.25% and 0.5%) Compared to Vehicle in the Conjunctival Allergen Challenge (Ora-CAC®) Model of Acute Allergic Conjunctivitis
Brief Summary A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions in Subjects with Acute Allergic Conjunctivitis
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Allergic Conjunctivitis
Intervention  ICMJE
  • Drug: Reproxalap Ophthalmic Solution (0.25%)
    Reproxalap Ophthalmic Solution (0.25%) administered once.
  • Drug: Reproxalap Ophthalmic Solution (0.5%)
    Reproxalap Ophthalmic Solution (0.5%) administered once.
  • Drug: Vehicle Ophthalmic Solution
    Vehicle Ophthalmic Solution administered once.
Study Arms  ICMJE
  • Experimental: Reproxalap Ophthalmic Solution (0.25%)
    Intervention: Drug: Reproxalap Ophthalmic Solution (0.25%)
  • Experimental: Reproxalap Ophthalmic Solution (0.5%)
    Intervention: Drug: Reproxalap Ophthalmic Solution (0.5%)
  • Placebo Comparator: Vehicle Ophthalmic Solution
    Intervention: Drug: Vehicle Ophthalmic Solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 8, 2019)
318
Original Estimated Enrollment  ICMJE
 (submitted: April 4, 2018)
300
Actual Study Completion Date  ICMJE November 5, 2018
Actual Primary Completion Date November 5, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 allergen (grasses, ragweed, and/or trees) as confirmed by an allergic skin test at the Screening Visit or 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 trial and/or a history of refractive surgery six (6) months prior to Visit 1 or have ocular or systemic surgery planned during the study or within 30 days after
  • 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 trial duration, or has a positive urine pregnancy test at Visit 1
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03494504
Other Study ID Numbers  ICMJE ADX-102-AC-008
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aldeyra Therapeutics, Inc.
Study Sponsor  ICMJE Aldeyra Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Aldeyra Therapeutics, Inc.
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP