Trial · NCT03479307

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

NCT03479307, Phase 3, Completed, Faes Farma, S.A.; results first posted 2021-12-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model. Trials, record NCT03479307. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03479307

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model.
NCT number: NCT03479307
Status: Completed
Phases: Phase 3
Enrollment: 228 participants, actual
Lead sponsor: Faes Farma, S.A.
Conditions: Allergic Conjunctivitis
Interventions: Bilastine Ophthalmic Solution 0.6%, Ketotifen Ophthalmic Solution 0.025% (Zaditen), Vehicle of Bilastine Ophthalmic Solution
First posted: 2018-03-27
Last updated: 2023-03-16
Results first posted: 2021-12-14

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Ocular Itching	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).

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Ocular Itching	The outcome measure was assessed at Visit 4b (Day 1: 16h post-treatment) and Visit 5 (Day 8 ±3, 15 minutes post-treatment).		units on a scale	MEAN

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Ocular Itching	Bilastine Ophthalmic Solution 0.6%	Visit 4b: 3 minutes Post- CAC	1.609	Standard Deviation 0.9013	units on a scale
Ocular Itching	Ketotifen Ophthalmic Solution 0.025% (Zaditen)	Visit 4b: 3 minutes Post- CAC	1.886	Standard Deviation 0.9504	units on a scale
Ocular Itching	Vehicle of Bilastine Ophthalmic Solution	Visit 4b: 3 minutes Post- CAC	2.219	Standard Deviation 0.9644	units on a scale
Ocular Itching	Bilastine Ophthalmic Solution 0.6%	Visit 4b: 5 minutes Post- CAC	1.750	Standard Deviation 0.9508	units on a scale
Ocular Itching	Ketotifen Ophthalmic Solution 0.025% (Zaditen)	Visit 4b: 5 minutes Post- CAC	1.919	Standard Deviation 0.9670	units on a scale
Ocular Itching	Vehicle of Bilastine Ophthalmic Solution	Visit 4b: 5 minutes Post- CAC	2.490	Standard Deviation 0.8996	units on a scale
Ocular Itching	Bilastine Ophthalmic Solution 0.6%	Visit 4b: 7 minutes Post- CAC	1.747	Standard Deviation 1.0283	units on a scale
Ocular Itching	Ketotifen Ophthalmic Solution 0.025% (Zaditen)	Visit 4b: 7 minutes Post- CAC	1.894	Standard Deviation 0.9606	units on a scale
Ocular Itching	Vehicle of Bilastine Ophthalmic Solution	Visit 4b: 7 minutes Post- CAC	2.526	Standard Deviation 0.9035	units on a scale
Ocular Itching	Bilastine Ophthalmic Solution 0.6%	Visit 5: 3 minutes Post- CAC	0.669	Standard Deviation 0.7926	units on a scale

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Bilastine Ophthalmic Solution 0.6%	91
Overall Study	STARTED	Ketotifen Ophthalmic Solution 0.025% (Zaditen)	90
Overall Study	STARTED	Vehicle of Bilastine Ophthalmic Solution	47
Overall Study	COMPLETED	Bilastine Ophthalmic Solution 0.6%	90
Overall Study	COMPLETED	Ketotifen Ophthalmic Solution 0.025% (Zaditen)	89
Overall Study	COMPLETED	Vehicle of Bilastine Ophthalmic Solution	47
Overall Study	NOT COMPLETED	Bilastine Ophthalmic Solution 0.6%	1
Overall Study	NOT COMPLETED	Ketotifen Ophthalmic Solution 0.025% (Zaditen)	1
Overall Study	NOT COMPLETED	Vehicle of Bilastine Ophthalmic Solution	0

Source ClinicalTrials.gov

Adverse events15

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Visual Acuty Reduced	Eye disorders	Bilastine Ophthalmic Solution 0.6%	3	91
other	Visual Acuty Reduced	Eye disorders	Ketotifen Ophthalmic Solution 0.025% (Zaditen)	0	90
other	Visual Acuty Reduced	Eye disorders	Vehicle of Bilastine Ophthalmic Solution	0	47
other	Conjunctivitis	Infections and infestations	Bilastine Ophthalmic Solution 0.6%	0	91
other	Conjunctivitis	Infections and infestations	Ketotifen Ophthalmic Solution 0.025% (Zaditen)	1	90
other	Conjunctivitis	Infections and infestations	Vehicle of Bilastine Ophthalmic Solution	0	47
other	Hordeolum	Infections and infestations	Bilastine Ophthalmic Solution 0.6%	0	91
other	Hordeolum	Infections and infestations	Ketotifen Ophthalmic Solution 0.025% (Zaditen)	1	90
other	Hordeolum	Infections and infestations	Vehicle of Bilastine Ophthalmic Solution	0	47
other	Sinusitis	Infections and infestations	Bilastine Ophthalmic Solution 0.6%	1	91

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Bilastine Ophthalmic Solution 0.6%	0	91
Total, all-cause mortality	Ketotifen Ophthalmic Solution 0.025% (Zaditen)	0	90
Total, all-cause mortality	Vehicle of Bilastine Ophthalmic Solution	0	47
Total, other adverse events	Bilastine Ophthalmic Solution 0.6%	4	91
Total, other adverse events	Ketotifen Ophthalmic Solution 0.025% (Zaditen)	2	90
Total, other adverse events	Vehicle of Bilastine Ophthalmic Solution	1	47
Total, serious adverse events	Bilastine Ophthalmic Solution 0.6%	0	91
Total, serious adverse events	Ketotifen Ophthalmic Solution 0.025% (Zaditen)	0	90
Total, serious adverse events	Vehicle of Bilastine Ophthalmic Solution	0	47

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36811846	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03479307

GET https://conductscience.org/api/trials/v1/NCT03479307/registered

API reference For AI assistants