Allergic ConjunctivitisPhase 2NCT03231969

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

A Phase 2 study testing Bilastine 0.2%, Bilastine 0.4% and Bilastine 0.6% in people with Allergic Conjunctivitis, run by Faes Farma, S.A. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Allergic Conjunctivitis
What is being tested?: Bilastine 0.2%, Bilastine 0.4% and Bilastine 0.6%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 121 participants
Where: 1 siteUnited States
Study dates: 20 Jul 2017to 11 Oct 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Ora Clinical Research Center
Andover, Massachusetts, 01810

Other trials in United States

About this study

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

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

Conditions: Allergic Conjunctivitis
Being tested: Bilastine 0.2%, Bilastine 0.4%, Bilastine 0.6%, Bilastine 0%
Medical subject headings: Conjunctivitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bilastine 0.2%Drug
1 drop in each eye at 3 separate times during a 25 day period.
Bilastine 0.4%Drug
1 drop in each eye at 3 separate times during a 25 day period.
Bilastine 0.6%Drug
1 drop in each eye at 3 separate times during a 25 day period.
Bilastine 0%Drug
1 drop in each eye at 3 separate times during a 25 day period.

Study groups in NCT03231969
Study group	Role	What they receive
Bilastine 0.2%	Experimental	Bilastine Ophthalmic solution 0.2% 1 drop in each eye at 3 separate times during a 25 day period. Receives: Drug: Bilastine 0.2%
Bilastine 0.4%	Experimental	Bilastine Ophthalmic solution 0.4% 1 drop in each eye at 3 separate times during a 25 day period. Receives: Drug: Bilastine 0.4%
Bilastine 0.6%	Experimental	Bilastine Ophthalmic solution 0.6% 1 drop in each eye at 3 separate times during a 25 day period. Receives: Drug: Bilastine 0.6%
Bilastine 0%	Placebo comparator	Vehicle of Bilastine Ophthalmic Solution 1 drop in each eye at 3 separate times during a 25 day period. Receives: Drug: Bilastine 0%

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jul 201711 Oct 2017

First posted27 Jul 2017
Study start20 Jul 2017
Primary completion11 Oct 2017
Study completion11 Oct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Allergic ConjunctivitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03231969
Sponsor's protocol ID: BOFT-0117/DR-CAC
Status last verified: Oct 2021
First submitted: 20 Jul 2017
Last updated: 16 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
Persistent Corneal Epithelial Defect
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Recruiting
Daydrop® Triple Action for Allergic Eye Symptoms
Allergic Conjunctivitis of Both Eyes
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Adult and Pediatric Participants With Allergic Conjunctivitis Due to Cat Allergy
Allergic Conjunctivitis
RecruitingObservational study
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All Allergic Conjunctivitis trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03231969
Acronym / sponsor ID: BOFT-0117/DR-CAC
Conditions: Allergic Conjunctivitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: Faes Farma, S.A.Industry (pharma, biotech, devices)
Collaborators: ORA, Inc.
Study start: 20 Jul 2017 (actual)
Primary completion: 11 Oct 2017 (actual)
Study completion: 11 Oct 2017 (actual)
First posted: 27 Jul 2017 (actual)
Results: Posted 24 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
Bilastine 0.2%	Experimental	Drug: Bilastine 0.2%Bilastine Ophthalmic solution 0.2% 1 drop in each eye at 3 separate times during a 25 day period.
Bilastine 0.4%	Experimental	Drug: Bilastine 0.4%Bilastine Ophthalmic solution 0.4% 1 drop in each eye at 3 separate times during a 25 day period.
Bilastine 0.6%	Experimental	Drug: Bilastine 0.6%Bilastine Ophthalmic solution 0.6% 1 drop in each eye at 3 separate times during a 25 day period.
Bilastine 0%	Placebo comparator	Drug: Bilastine 0%Vehicle of Bilastine Ophthalmic Solution 1 drop in each eye at 3 separate times during a 25 day period.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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 (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bilastine 0.2%1 drop in each eye at 3 separate times during a 25 day period.	Drug	Bilastine 0.2%
Bilastine 0.4%1 drop in each eye at 3 separate times during a 25 day period.	Drug	Bilastine 0.4%
Bilastine 0.6%1 drop in each eye at 3 separate times during a 25 day period.	Drug	Bilastine 0.6%
Bilastine 0%1 drop in each eye at 3 separate times during a 25 day period.	Drug	Bilastine 0%

Primary outcome

Ocular Itching
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).
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.

Results and safety

Results posted to the registry on 24 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bilastine 0.2%	30	28
Bilastine 0.4%	30	28
Bilastine 0.6%	31	30
Bilastine 0%	30	30

Primary outcome: Ocular Itching

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).. Mean (Standard Deviation). Unit: units on a scale

Measure	Bilastine 0.2% n = 30	Bilastine 0.4% n = 30	Bilastine 0.6% n = 31	Bilastine 0% (Vehicle) n = 30
Visit 4b: 3 minutes Post-CAC	1.908 (0.7809)	1.925 (0.9449)	1.177 (1.0332)	2.758 (0.7146)
Visit 4b: 5 minutes Post-CAC	2.075 (0.7828)	2.117 (0.9531)	1.218 (1.1268)	3.017 (0.5979)
Visit 4b: 7 minutes Post-CAC	2.092 (0.7698)	2.100 (1.0760)	1.218 (1.1157)	2.917 (0.5884)
Visit 5b: 3 minutes Post-CAC	1.397 (1.1050)	1.250 (0.8872)	0.708 (0.8908)	2.558 (0.8032)
Visit 5b: 5 minutes Post-CAC	1.466 (0.9300)	1.464 (0.9592)	0.817 (1.0503)	2.642 (0.7505)
Visit 5b: 7 minutes Post-CAC	1.379 (0.8573)	1.518 (1.0340)	0.742 (0.9837)	2.642 (0.7704)
Visit 6: 3 minutes Post-CAC	0.679 (0.6662)	0.732 (0.9127)	0.392 (0.5749)	2.542 (0.8384)
Visit 6: 5 minutes Post-CAC	0.920 (0.7235)	1.143 (0.9987)	0.558 (0.6355)	2.592 (0.8343)

Bilastine 0.2% vs Bilastine 0% (Vehicle): Mean Difference (Final Values): -0.791 (95% CI -1.203 to -0.378), p = 0.0002, ANCOVA
Bilastine 0.4% vs Bilastine 0% (Vehicle): Mean Difference (Final Values): -0.851 (95% CI -1.263 to -0.439), p <.0001, ANCOVA
Bilastine 0.6% vs Bilastine 0% (Vehicle): Mean Difference (Final Values): -1.545 (95% CI -1.954 to -1.135), p <.0001, ANCOVA

Adverse events

Time frame: Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bilastine 0.2%	0 of 30 (0%)	8 of 30 (26.7%)	0 of 30
Bilastine 0.4%	0 of 30 (0%)	3 of 30 (10%)	0 of 30
Bilastine 0.6%	0 of 31 (0%)	1 of 31 (3.2%)	0 of 31
Bilastine 0%	0 of 30 (0%)	7 of 30 (23.3%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Allergic Conjunctivitis

RecruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bilastine 0.2%, Bilastine 0.4% and Bilastine 0.6% in people with Allergic Conjunctivitis, run by Faes Farma, S.A. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ocular Itching (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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03231969.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.