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

Phase 2

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: Patanol; Drug: PRT-2761 1%; Drug: Pred-forte; Drug: PRT-2761 0.5%; Drug: PRT-2761 0%

• Registration Number: NCT03320434
• Lead Sponsor: ORA, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-13
• Study First Submitted: 2017-10-19
• Study First Submitted QC: 2017-10-23
• Study First Posted: 2017-10-25
• Primary Completion: 2018-02-16
• Study Completion: 2018-02-18
• Disposition First Submitted: 2020-08-19
• Results First Submitted: 2022-07-11
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-13
• Disposition First Submitted QC: 2022-10-13
• Last Update Submitted: 2022-10-13
• Results First Posted: 2022-10-17
• Disposition First Posted: 2022-10-17
• Last Update Posted: 2022-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patanol	Patanol	-
PRT-2761 1%	PRT-2761 1%	-
Pred-forte	Pred-forte	-
PRT-2761 0.5%	PRT-2761 0.5%	-
PRT-2761 0%	PRT-2761 0%	-

Primary Outcome Measures

Name	Time	Method
Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1	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	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	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	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.

Trial Locations

Locations (1)

Andover Eye Associates; 🇺🇸 Andover, Massachusetts, United States