A Single-Center, Phase 2 Study Evaluating Bilastine Ophthalmic Solution in the CAC® Model

March 15, 2023 updated by: Faes Farma, S.A.

A Single-Center, Double-Masked, Randomized, Vehicle-Controlled, Phase 2, Dose Ranging Evaluation of the Effectiveness of Bilastine Ophthalmic Solution (0.2%, 0.4%, and 0.6%) Compared to Vehicle for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (Ora-CAC®) Model

To evaluate the efficacy of Bilastine Ophthalmic Solution (0.2%,0.4%,0.6%) compared to vehicle for the treatment of the signs and symptoms of allergic conjunctivitis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Andover, Massachusetts, United States, 01810
        • Ora Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key 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

Key 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 immunotherapy in the last 2 years
  • must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bilastine 0.2%

Bilastine Ophthalmic solution 0.2%

1 drop in each eye at 3 separate times during a 25 day period.
Drug: Bilastine 0.2%
1 drop in each eye at 3 separate times during a 25 day period.
Experimental: Bilastine 0.4%

Bilastine Ophthalmic solution 0.4%

1 drop in each eye at 3 separate times during a 25 day period.
Drug: Bilastine 0.4%
1 drop in each eye at 3 separate times during a 25 day period.
Experimental: Bilastine 0.6%

Bilastine Ophthalmic solution 0.6%

1 drop in each eye at 3 separate times during a 25 day period.
Drug: Bilastine 0.6%
1 drop in each eye at 3 separate times during a 25 day period.
Placebo Comparator: Bilastine 0%

Vehicle of Bilastine Ophthalmic Solution

1 drop in each eye at 3 separate times during a 25 day period.
Drug: Bilastine 0%
1 drop in each eye at 3 separate times during a 25 day period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular Itching
Time Frame: The outcome measure was assessed at Visit 4b (Day 1, 16h post treatment), Visit 5b (Day 15 ±3, 8h post treatment), and Visit 6 (Day 22 ±3, 15 minutes post treatment).
The primary efficacy measure was ocular itching evaluated by the subject post-CAC (Conjunctival Allergen Challenge) at Visits 4b, 5b, and 6, using a 0 to 4 Ora Calibra scale: 0 = none (normal, no itching), 4 = incapacitating itch.
The outcome measure was assessed at Visit 4b (Day 1, 16h post treatment), Visit 5b (Day 15 ±3, 8h post treatment), and Visit 6 (Day 22 ±3, 15 minutes post treatment).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faes Farma, S.A.

Collaborators

ORA, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2017

Primary Completion (Actual)

October 11, 2017

Study Completion (Actual)

October 11, 2017

Study Registration Dates

First Submitted

July 20, 2017

First Submitted That Met QC Criteria

July 26, 2017

First Posted (Actual)

July 27, 2017

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BOFT-0117/DR-CAC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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