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

Primary Purpose

Allergic Conjunctivitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PRT-2761 0.5%
PRT-2761 1%
Patanol
Pred-forte
PRT-2761 0%
Sponsored by
ORA, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Conjunctivitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Andover Eye Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

PRT-2761 0.5%

PRT-2761 1%

Patanol

Pred-forte

PRT-2761 0%

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 19, 2017
Last Updated
October 13, 2022
Sponsor
ORA, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03320434
Brief Title
Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis
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®)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 13, 2017 (Actual)
Primary Completion Date
February 16, 2018 (Actual)
Study Completion Date
February 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ORA, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRT-2761 0.5%
Arm Type
Experimental
Arm Title
PRT-2761 1%
Arm Type
Experimental
Arm Title
Patanol
Arm Type
Active Comparator
Arm Title
Pred-forte
Arm Type
Active Comparator
Arm Title
PRT-2761 0%
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PRT-2761 0.5%
Intervention Description
Six drops in each eye over a 17 day period.
Intervention Type
Drug
Intervention Name(s)
PRT-2761 1%
Intervention Description
Six drops in each eye over a 17 day period.
Intervention Type
Drug
Intervention Name(s)
Patanol
Intervention Description
Six drops in each eye over a 17 day period.
Intervention Type
Drug
Intervention Name(s)
Pred-forte
Intervention Description
Four drops in each eye over a 3 day period.
Intervention Type
Drug
Intervention Name(s)
PRT-2761 0%
Intervention Description
Six drops in each eye over a 17 day period.
Primary Outcome Measure Information:
Title
Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1
Description
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.
Time Frame
post CAC exposure at 5, 7, and 10 minutes post CAC on Day 1
Title
Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15
Description
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.
Time Frame
post CAC exposure at 5, 7, and 10 minutes post CAC on Day 15
Title
Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1
Description
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.
Time Frame
post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 1.
Title
Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15
Description
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.
Time Frame
post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 15.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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