NCT03320434

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 25, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2018

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2018

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

October 17, 2022

Completed
Last Updated

October 17, 2022

Status Verified

October 1, 2022

Enrollment Period

4 months

First QC Date

October 19, 2017

Results QC Date

July 11, 2022

Last Update Submit

October 13, 2022

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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.

  • 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.

Study Arms (5)

PRT-2761 0.5%

EXPERIMENTAL
Drug: PRT-2761 0.5%

PRT-2761 1%

EXPERIMENTAL
Drug: PRT-2761 1%

Patanol

ACTIVE COMPARATOR
Drug: Patanol

Pred-forte

ACTIVE COMPARATOR
Drug: Pred-forte

PRT-2761 0%

PLACEBO COMPARATOR
Drug: PRT-2761 0%

Interventions

PRT-2761 0.5%DRUG

Six drops in each eye over a 17 day period.

PRT-2761 0.5%
PRT-2761 1%DRUG

Six drops in each eye over a 17 day period.

PRT-2761 1%
PatanolDRUG

Six drops in each eye over a 17 day period.

Patanol
Pred-forteDRUG

Four drops in each eye over a 3 day period.

Pred-forte
PRT-2761 0%DRUG

Six drops in each eye over a 17 day period.

PRT-2761 0%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

Olopatadine HydrochlorideMethylprednisolone

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

DibenzoxepinsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Caitlin Pearson
Organization
Ora, Inc
cpearson@oraclinical.com
978-685-8900

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2017

First Posted

October 25, 2017

Study Start

October 13, 2017

Primary Completion

February 16, 2018

Study Completion

February 18, 2018

Last Updated

October 17, 2022

Results First Posted

October 17, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)