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®)
Overview
- Phase
- Phase 2
- Intervention
- PRT-2761 0.5%
- Conditions
- Allergic Conjunctivitis
- Sponsor
- ORA, Inc.
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
PRT-2761 0.5%
Intervention: PRT-2761 0.5%
PRT-2761 1%
Intervention: PRT-2761 1%
Patanol
Intervention: Patanol
Pred-forte
Intervention: Pred-forte
PRT-2761 0%
Intervention: PRT-2761 0%
Outcomes
Primary Outcomes
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.
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.
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.