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

NCT03479307 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2023-03-16

Study results available
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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.

Conditions

  • Allergic Conjunctivitis

Interventions

DRUG

Bilastine Ophthalmic Solution 0.6%

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

DRUG

Ketotifen Ophthalmic Solution 0.025% (Zaditen)

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

DRUG

Vehicle of Bilastine Ophthalmic Solution

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

Sponsors & Collaborators

  • ORA, Inc.

    collaborator INDUSTRY

  • Faes Farma, S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-07
Primary Completion
2018-08-09
Completion
2018-08-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03479307 on ClinicalTrials.gov