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

Primary Purpose

Allergic Conjunctivitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bilastine 0.2%
Bilastine 0.4%
Bilastine 0.6%
Bilastine 0%
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

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

Sites / Locations

  • Ora Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Bilastine 0.2%

Bilastine 0.4%

Bilastine 0.6%

Bilastine 0%

Arm Description

Bilastine Ophthalmic solution 0.2% 1 drop in each eye at 3 separate times during a 25 day period.

Bilastine Ophthalmic solution 0.4% 1 drop in each eye at 3 separate times during a 25 day period.

Bilastine Ophthalmic solution 0.6% 1 drop in each eye at 3 separate times during a 25 day period.

Vehicle of Bilastine Ophthalmic Solution 1 drop in each eye at 3 separate times during a 25 day period.

Outcomes

Primary Outcome Measures

Ocular Itching
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.

Secondary Outcome Measures

Full Information

First Posted
July 20, 2017
Last Updated
March 15, 2023
Sponsor
Faes Farma, S.A.
Collaborators
ORA, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03231969
Brief Title
A Single-Center, Phase 2 Study Evaluating Bilastine Ophthalmic Solution in the CAC® Model
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 20, 2017 (Actual)
Primary Completion Date
October 11, 2017 (Actual)
Study Completion Date
October 11, 2017 (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 (0.2%,0.4%,0.6%) compared to vehicle 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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bilastine 0.2%
Arm Type
Experimental
Arm Description
Bilastine Ophthalmic solution 0.2% 1 drop in each eye at 3 separate times during a 25 day period.
Arm Title
Bilastine 0.4%
Arm Type
Experimental
Arm Description
Bilastine Ophthalmic solution 0.4% 1 drop in each eye at 3 separate times during a 25 day period.
Arm Title
Bilastine 0.6%
Arm Type
Experimental
Arm Description
Bilastine Ophthalmic solution 0.6% 1 drop in each eye at 3 separate times during a 25 day period.
Arm Title
Bilastine 0%
Arm Type
Placebo Comparator
Arm Description
Vehicle of Bilastine Ophthalmic Solution 1 drop in each eye at 3 separate times during a 25 day period.
Intervention Type
Drug
Intervention Name(s)
Bilastine 0.2%
Intervention Description
1 drop in each eye at 3 separate times during a 25 day period.
Intervention Type
Drug
Intervention Name(s)
Bilastine 0.4%
Intervention Description
1 drop in each eye at 3 separate times during a 25 day period.
Intervention Type
Drug
Intervention Name(s)
Bilastine 0.6%
Intervention Description
1 drop in each eye at 3 separate times during a 25 day period.
Intervention Type
Drug
Intervention Name(s)
Bilastine 0%
Intervention Description
1 drop in each eye at 3 separate times during a 25 day period.
Primary Outcome Measure Information:
Title
Ocular Itching
Description
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.
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ora Clinical Research Center
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

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

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