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A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model.

Primary Purpose

Allergic Conjunctivitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bilastine Ophthalmic Solution 0.6%
Ketotifen Ophthalmic Solution 0.025% (Zaditen)
Vehicle of Bilastine Ophthalmic Solution
Sponsored by
Faes Farma, S.A.
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 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

Sites / Locations

  • Cornea Consultants of AZ
  • East West Eye Institute
  • Andover Eye Associates
  • Apex Eye
  • Philadelphia Eye Associates
  • Total Eye Care, P.A.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Bilastine Ophthalmic Solution 0.6%

Ketotifen Ophthalmic Solution 0.025% (Zaditen)

Vehicle of Bilastine Ophthalmic Solution

Arm Description

Bilastine Ophthalmic Solution 0.6% 1 drop in each eye at 2 separate times during an 8 day period.

Ketotifen Ophthalmic Solution 0.025% (Zaditen) 1 drop in each eye at 2 separate times during an 8 day period.

Vehicle of Bilastine Ophthalmic Solution 1 drop in each eye at 2 separate times during an 8 day period.

Outcomes

Primary Outcome Measures

Ocular Itching
The primary efficacy measure was ocular itching evaluated by the subject at 3 (± 1), 5 (±1), and 7 (± 1) minutes post-CAC (Conjunctival Allergen Challenge) at Visits 4b and 5, using a 0 to 4 Ora Calibra scale (0 = None , 4= An incapacitating itch with an irresistible urge to rub).

Secondary Outcome Measures

Full Information

First Posted
March 21, 2018
Last Updated
March 15, 2023
Sponsor
Faes Farma, S.A.
Collaborators
ORA, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03479307
Brief Title
A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model.
Official Title
A Multi-Center, Double-Masked, Randomized, Vehicle- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Bilastine Ophthalmic Solution 0.6% Compared to Vehicle and Zaditen (Ketotifen Ophthalmic Solution 0.025%) for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (Ora-CAC®) Model
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 7, 2018 (Actual)
Primary Completion Date
August 9, 2018 (Actual)
Study Completion Date
August 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Faes Farma, S.A.
Collaborators
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 of Bilastine ophthalmic solution 0.6% compared to vehicle and Zaditen (Ketotifen ophthalmic solution 0.025%) for the treatment of the signs and symptoms of 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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
228 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bilastine Ophthalmic Solution 0.6%
Arm Type
Experimental
Arm Description
Bilastine Ophthalmic Solution 0.6% 1 drop in each eye at 2 separate times during an 8 day period.
Arm Title
Ketotifen Ophthalmic Solution 0.025% (Zaditen)
Arm Type
Active Comparator
Arm Description
Ketotifen Ophthalmic Solution 0.025% (Zaditen) 1 drop in each eye at 2 separate times during an 8 day period.
Arm Title
Vehicle of Bilastine Ophthalmic Solution
Arm Type
Placebo Comparator
Arm Description
Vehicle of Bilastine Ophthalmic Solution 1 drop in each eye at 2 separate times during an 8 day period.
Intervention Type
Drug
Intervention Name(s)
Bilastine Ophthalmic Solution 0.6%
Intervention Description
1 drop in each eye at 2 separate times during an 8 day period.
Intervention Type
Drug
Intervention Name(s)
Ketotifen Ophthalmic Solution 0.025% (Zaditen)
Other Intervention Name(s)
Zaditen
Intervention Description
1 drop in each eye at 2 separate times during an 8 day period.
Intervention Type
Drug
Intervention Name(s)
Vehicle of Bilastine Ophthalmic Solution
Intervention Description
1 drop in each eye at 2 separate times during an 8 day period.
Primary Outcome Measure Information:
Title
Ocular Itching
Description
The primary efficacy measure was ocular itching evaluated by the subject at 3 (± 1), 5 (±1), and 7 (± 1) minutes post-CAC (Conjunctival Allergen Challenge) at Visits 4b and 5, using a 0 to 4 Ora Calibra scale (0 = None , 4= An incapacitating itch with an irresistible urge to rub).
Time Frame
The outcome measure was assessed at Visit 4b (Day 1: 16h post-treatment) and Visit 5 (Day 8 ±3, 15 minutes post-treatment).

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 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
Facility Information:
Facility Name
Cornea Consultants of AZ
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
East West Eye Institute
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
Apex Eye
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Philadelphia Eye Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States
Facility Name
Total Eye Care, P.A.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model.

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