CompletedNCT03479307Updated Mar 16, 2023Results posted

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

A Phase 3 interventional study of Bilastine Ophthalmic Solution 0.6% and Ketotifen Ophthalmic Solution 0.025% (Zaditen) in Allergic Conjunctivitis, sponsored by Faes Farma, S.A.. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-16.

Sponsored by Faes Farma, S.A. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 228
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 studied

Allergic Conjunctivitis

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 228 participants (actual)

Study arms

Experimental
Bilastine Ophthalmic Solution 0.6%
Bilastine Ophthalmic Solution 0.6% 1 drop in each eye at 2 separate times during an 8 day period.
Drug: Bilastine Ophthalmic Solution 0.6%
Active comparator
Ketotifen Ophthalmic Solution 0.025% (Zaditen)
Ketotifen Ophthalmic Solution 0.025% (Zaditen) 1 drop in each eye at 2 separate times during an 8 day period.
Drug: Ketotifen Ophthalmic Solution 0.025% (Zaditen)
Placebo comparator
Vehicle of Bilastine Ophthalmic Solution
Vehicle of Bilastine Ophthalmic Solution 1 drop in each eye at 2 separate times during an 8 day period.
Drug: Vehicle of Bilastine Ophthalmic Solution

Interventions

DrugBilastine Ophthalmic Solution 0.6%
1 drop in each eye at 2 separate times during an 8 day period.
DrugKetotifen Ophthalmic Solution 0.025% (Zaditen)
1 drop in each eye at 2 separate times during an 8 day period.
Also known as: Zaditen
DrugVehicle of Bilastine Ophthalmic Solution
1 drop in each eye at 2 separate times during an 8 day period.

What researchers measure

Primary outcomes

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).
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).

Results

Posted Dec 14, 2021

Participant flow

Participant flow — Overall Study
Milestone	Bilastine Ophthalmic Solution 0.6%	Ketotifen Ophthalmic Solution 0.025% (Zaditen)	Vehicle of Bilastine Ophthalmic Solution
Started	91	90	47
Completed	90	89	47
Not completed	1	1	0

Outcome measures

PrimaryOcular 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).

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).
Reported as:: Mean · units on a scale

Ocular Itching
units on a scale	Bilastine Ophthalmic Solution 0.6%	Ketotifen Ophthalmic Solution 0.025% (Zaditen)	Vehicle of Bilastine Ophthalmic Solution
Visit 4b: 3 minutes Post- CAC	1.609 ± 0.9013	1.886 ± 0.9504	2.219 ± 0.9644
Visit 4b: 5 minutes Post- CAC	1.750 ± 0.9508	1.919 ± 0.9670	2.490 ± 0.8996
Visit 4b: 7 minutes Post- CAC	1.747 ± 1.0283	1.894 ± 0.9606	2.526 ± 0.9035
Visit 5: 3 minutes Post- CAC	0.669 ± 0.7926	0.658 ± 0.6745	1.840 ± 0.9258
Visit 5: 5 minutes Post- CAC	0.828 ± 0.8879	0.902 ± 0.8208	2.011 ± 0.9058
Visit 5: 7 minutes Post- CAC	0.826 ± 0.8901	0.981 ± 0.9224	1.931 ± 0.8703

Statistical analysis

Bilastine Ophthalmic Solution 0.6% vs Vehicle of Bilastine Ophthalmic Solution · ANCOVA · p = < 0.0001 · Mean difference (final values): -0.710 · 95% CI -1.013 to -0.407
Bilastine Ophthalmic Solution 0.6% vs Vehicle of Bilastine Ophthalmic Solution · ANCOVA · p = < 0.0001 · Mean difference (final values): -1.167 · 95% CI -1.439 to -0.895
Ketotifen Ophthalmic Solution 0.025% (Zaditen) vs Vehicle of Bilastine Ophthalmic Solution · ANCOVA · p = < 0.0001 · Mean difference (final values): -1.140 · 95% CI -1.413 to -0.868
Bilastine Ophthalmic Solution 0.6% vs Ketotifen Ophthalmic Solution 0.025% (Zaditen) · ANCOVA · p = 0.0007 · Mean difference (final values): 0.009
Bilastine Ophthalmic Solution 0.6% vs Ketotifen Ophthalmic Solution 0.025% (Zaditen) · ANCOVA · p = 0.0002 · Mean difference (final values): -0.077
Bilastine Ophthalmic Solution 0.6% vs Ketotifen Ophthalmic Solution 0.025% (Zaditen) · ANCOVA · p = < 0.0001 · Mean difference (final values): -0.159

Adverse events

Collected over Safety assessment period (Day 1 through Day 8): Adverse events were assessed at all office visits, throughout a period of 8 days.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Bilastine Ophthalmic Solution 0.6%	0/91 (0%)	0/91 (0%)	4/91 (4.4%)
Ketotifen Ophthalmic Solution 0.025% (Zaditen)	0/90 (0%)	0/90 (0%)	2/90 (2.2%)
Vehicle of Bilastine Ophthalmic Solution	0/47 (0%)	0/47 (0%)	1/47 (2.1%)

Most frequent other events

Most frequent other events
Event	Bilastine Ophthalmic Solution 0.6%	Ketotifen Ophthalmic Solution 0.025% (Zaditen)	Vehicle of Bilastine Ophthalmic Solution
Visual Acuty ReducedEye disorders	3/91	0/90	0/47
Tooth AbscessInfections and infestations	0/91	0/90	1/47
ConjunctivitisInfections and infestations	0/91	1/90	0/47
HordeolumInfections and infestations	0/91	1/90	0/47
SinusitisInfections and infestations	1/91	0/90	0/47

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Bilastine Ophthalmic Solution 0.6%	Ketotifen Ophthalmic Solution 0.025% (Zaditen)	Vehicle of Bilastine Ophthalmic Solution	Total
<=18 years	0	0	0	0
Between 18 and 65 years	85	89	43	217
>=65 years	6	1	4	11

Age, Continuous
Age, Continuous(years)	Bilastine Ophthalmic Solution 0.6%	Ketotifen Ophthalmic Solution 0.025% (Zaditen)	Vehicle of Bilastine Ophthalmic Solution	Total
Mean	45.9 ± 12.88	41.7 ± 12.1	45.1 ± 16.03	44.1 ± 13.38

Sex: Female, Male
Sex: Female, Male(Participants)	Bilastine Ophthalmic Solution 0.6%	Ketotifen Ophthalmic Solution 0.025% (Zaditen)	Vehicle of Bilastine Ophthalmic Solution	Total
Female	58	53	25	136
Male	33	37	22	92

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Bilastine Ophthalmic Solution 0.6%	Ketotifen Ophthalmic Solution 0.025% (Zaditen)	Vehicle of Bilastine Ophthalmic Solution	Total
Hispanic or Latino	11	10	6	27
Not Hispanic or Latino	80	79	41	200
Unknown or Not Reported	0	1	0	1

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Bilastine Ophthalmic Solution 0.6%	Ketotifen Ophthalmic Solution 0.025% (Zaditen)	Vehicle of Bilastine Ophthalmic Solution	Total
American Indian or Alaska Native	1	1	1	3
Asian	14	13	6	33
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	25	27	14	66
White	49	48	26	123
More than one race	2	1	0	3
Unknown or Not Reported	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Bilastine Ophthalmic Solution 0.6%	Ketotifen Ophthalmic Solution 0.025% (Zaditen)	Vehicle of Bilastine Ophthalmic Solution	Total
United States	91	90	47	228

Ocular Itching- Baseline
Ocular Itching- Baseline(units on a scale)	Bilastine Ophthalmic Solution 0.6%	Ketotifen Ophthalmic Solution 0.025% (Zaditen)	Vehicle of Bilastine Ophthalmic Solution	Total
Visit 4b: Pre-CAC	0.014 ± 0.0945	0.011 ± 0.1054	0.043 ± 0.2949	0.023 ± 0.1649
Visit 5: Pre-CAC	0.000 ± 0.0000	0.000 ± 0.0000	0.000 ± 0.0000	0.000 ± 0.0000

Study locations

6 sites

Cornea Consultants of AZ
Phoenix, Arizona 85032, United States
East West Eye Institute
Torrance, California 90505, United States
Andover Eye Associates
Andover, Massachusetts 01810, United States
Apex Eye
Mason, Ohio 45040, United States
Philadelphia Eye Associates
Philadelphia, Pennsylvania 19134, United States
Total Eye Care, P.A.
Memphis, Tennessee 38119, United States

References and documents

Study documents

Protocol and statistical analysis plan · Jan 29, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03479307
Lead sponsor: Faes Farma, S.A.
Collaborators: ORA, Inc.
Responsible party: Sponsor
First posted: Mar 27, 2018
Start date: Apr 7, 2018
Primary completion: Aug 9, 2018
Completion: Aug 10, 2018
Results posted: Dec 14, 2021
Last update: Mar 16, 2023

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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