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Completed

NCT Number: NCT03479307

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

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.

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Key information

Conditions

Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cornea Consultants of AZ, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bilastine Ophthalmic Solution 0.6%

Drug

1 drop in each eye at 2 separate times during an 8 day period.

Ketotifen Ophthalmic Solution 0.025% (Zaditen)

Drug

1 drop in each eye at 2 separate times during an 8 day period.

Other names: Zaditen

Vehicle of Bilastine Ophthalmic Solution

Drug

1 drop in each eye at 2 separate times during an 8 day period.

Primary outcomes

  1. Ocular Itching

    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).

    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).

Sponsors and collaborators

Lead sponsor

Faes Farma, S.A.

Industry

Collaborators

  • ORA, Inc.

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 27, 2018
Registry last updated
Mar 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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