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

Ora, Inc.

Status and phase: Completed; Phase 2

Conditions: Allergic Conjunctivitis

Treatments: Drug: PRT-2761 1%; Drug: Patanol; Drug: PRT-2761 0.5%; Drug: PRT-2761 0%; Drug: Pred-forte

Study type: Interventional

Funder types: Industry

Identifiers

NCT03320434

17-100-0008

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 5 patient groups, including a placebo group

PRT-2761 0.5%

Experimental group

Treatment:

Drug: PRT-2761 0.5%

PRT-2761 1%

Experimental group

Treatment:

Drug: PRT-2761 1%

Patanol

Active Comparator group

Treatment:

Drug: Patanol

Pred-forte

Active Comparator group

Treatment:

Drug: Pred-forte

PRT-2761 0%

Placebo Comparator group

Treatment:

Drug: PRT-2761 0%