Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis

Overview

To evaluate the efficacy and safety of two concentrations of PRT-2761 as a topical ophthalmic solution for the treatment of the signs and symptoms of acute and chronic allergic conjunctivitis.

Full Title of Study: “A Single-Center, Randomized, Double-Masked, Vehicle and Active-Controlled, Dose-Ranging Phase 2 Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis Using the Conjunctival Allergen Challenge Model (Ora-CAC®)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: February 16, 2018

Interventions

  • Drug: PRT-2761 0.5%
    • Six drops in each eye over a 17 day period.
  • Drug: PRT-2761 1%
    • Six drops in each eye over a 17 day period.
  • Drug: Patanol
    • Six drops in each eye over a 17 day period.
  • Drug: Pred-forte
    • Four drops in each eye over a 3 day period.
  • Drug: PRT-2761 0%
    • Six drops in each eye over a 17 day period.

Arms, Groups and Cohorts

  • Experimental: PRT-2761 0.5%
  • Experimental: PRT-2761 1%
  • Active Comparator: Patanol
  • Active Comparator: Pred-forte
  • Placebo Comparator: PRT-2761 0%

Clinical Trial Outcome Measures

Primary Measures

  • Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1
    • Time Frame: post CAC exposure at 5, 7, and 10 minutes post CAC on Day 1
    • Ocular Itching was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no itching) to 4=severe (worst/most itching). The ocular itching was averaged across all subjects at each time point.
  • Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15
    • Time Frame: post CAC exposure at 5, 7, and 10 minutes post CAC on Day 15
    • Ocular Itching was assessed by the subjects using a 0 to 4 point scale(0=none (best/no itching) to 4=severe (worst/most itching)). The ocular itching was averaged across all subjects at each time point.
  • Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1
    • Time Frame: post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 1.
    • Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)). The conjunctival redness was averaged across all subjects at each time point.
  • Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15
    • Time Frame: post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 15.
    • Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)). The conjunctival redness was averaged across all subjects at each time point.

Participating in This Clinical Trial

Inclusion Criteria

  • be at least 18 years old – be willing and able to avoid all disallowed medications and contact lenses – must have a pregnancy test if of childbearing potential – must be able to read an eye chart from 10 feet away Exclusion Criteria:

  • must not have any allergies to the study medications – must not have any ocular or non ocular condition that investigator feels will interfere with study parameters – must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ORA, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

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