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

Allergic Conjunctivitis Clinical Trial

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®)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03320434
• Other study ID #: 17-100-0008
• Status: Completed
• Phase: Phase 2
• Start date: October 13, 2017
• Est. completion date: February 18, 2018

Study information

• Verified date: October 2022
• Source: ORA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 18, 2018
• Est. primary completion date: February 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

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

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
ORA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Itching 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.	post CAC exposure at 5, 7, and 10 minutes post CAC on Day 1
Primary	Ocular Itching 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.	post CAC exposure at 5, 7, and 10 minutes post CAC on Day 15
Primary	Conjunctival Redness 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.	post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 1.
Primary	Conjunctival Redness 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.	post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 15.