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

Sponsor

ORA, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03320434

Collaborator

(none)

120

Enrollment

Location

Arms

4.2

Actual Duration (Months)

28.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Allergic Conjunctivitis	Drug: PRT-2761 0.5% Drug: PRT-2761 1% Drug: Patanol Drug: Pred-forte Drug: PRT-2761 0%	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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®)

Actual Study Start Date :

Oct 13, 2017

Actual Primary Completion Date :

Feb 16, 2018

Actual Study Completion Date :

Feb 18, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PRT-2761 0.5%	Drug: PRT-2761 0.5% Six drops in each eye over a 17 day period.
Experimental: PRT-2761 1%	Drug: PRT-2761 1% Six drops in each eye over a 17 day period.
Active Comparator: Patanol	Drug: Patanol Six drops in each eye over a 17 day period.
Active Comparator: Pred-forte	Drug: Pred-forte Four drops in each eye over a 3 day period.
Placebo Comparator: PRT-2761 0%	Drug: PRT-2761 0% Six drops in each eye over a 17 day period.

Outcome Measures

Primary Outcome Measures

Ocular Itching [5 minutes post CAC at visit 4b]
Ocular Itching will be assessed by the subjects using a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes will be analyzed.
Ocular Itching [7 minutes post CAC at visit 4b]
Ocular Itching will be assessed by the subjects using a 0-4 scale(0=none to 4=severe). Average of ocular itching score over both eyes will be analyzed.
Ocular Itching [10 minutes post CAC at visit 4b]
Ocular Itching will be assessed by the subjects using a 0-4 scale(0=none to 4=severe). Average of ocular itching score over both eyes will be analyzed.
Ocular Itching [5 minutes post CAC at visit 5a]
Ocular Itching will be assessed by the subjects using a 0-4 scale(0=none to 4=severe). Average of ocular itching score over both eyes will be analyzed.
Ocular Itching [7 minutes post CAC at visit 5a]
Ocular Itching will be assessed by the subjects using a 0-4 scale(0=none to 4=severe). Average of ocular itching score over both eyes will be analyzed.
Ocular Itching [10 minutes post CAC at visit 5a]
Ocular Itching will be assessed by the subjects using a 0-4 scale(0=none to 4=severe). Average of ocular itching score over both eyes will be analyzed.
Conjunctival Redness [7 minutes post-CAC at visit 4b]
Conjunctival Redness will be assessed by the investigator using a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes will be analyzed.
Conjunctival Redness [15 minutes post-CAC at visit 4b]
Conjunctival Redness will be assessed by the investigator using a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes will be analyzed.
Conjunctival Redness [20 minutes post-CAC at visit 4b]
Conjunctival Redness will be assessed by the investigator using a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes will be analyzed.
Conjunctival Redness [7 minutes post-CAC at visit 5a]
Conjunctival Redness will be assessed by the investigator using a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes will be analyzed.
Conjunctival Redness [15 minutes post-CAC at visit 5a]
Conjunctival Redness will be assessed by the investigator using a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes will be analyzed.
Conjunctival Redness [20 minutes post-CAC at visit 5a]
Conjunctival Redness will be assessed by the investigator using a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes will be analyzed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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