Allergic ConjunctivitisPhase 3NCT03479307
A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model.
A Phase 3 study testing Bilastine Ophthalmic Solution 0.6% and Ketotifen Ophthalmic Solution 0.025% (Zaditen) in people with Allergic Conjunctivitis, run by Faes Farma, S.A. at 6 sites in United States.
Trial 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. 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 Ophthalmic Solution 0.6% and Ketotifen Ophthalmic Solution 0.025% (Zaditen)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 6 sitesUnited States
- Study dates
- 7 Apr 2018to 10 Aug 2018
- Phase
- Phase 3
- 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
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Andover Eye Associates
Andover, Massachusetts, 01810
Apex Eye
Mason, Ohio, 45040
Total Eye Care, P.A.
Memphis, Tennessee, 38119
Philadelphia Eye Associates
Philadelphia, Pennsylvania, 19134
Cornea Consultants of AZ
Phoenix, Arizona, 85032
East West Eye Institute
Torrance, California, 90505
About this study
Official 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
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
- Being tested
- Bilastine Ophthalmic Solution 0.6%, Ketotifen Ophthalmic Solution 0.025% (Zaditen), Vehicle of Bilastine Ophthalmic Solution
- 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 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
Also called Zaditen
1 drop in each eye at 2 separate times during an 8 day period.
Vehicle of Bilastine Ophthalmic SolutionDrug
1 drop in each eye at 2 separate times during an 8 day period.
| Study group | Role | What they receive |
|---|---|---|
| Bilastine Ophthalmic Solution 0.6% | Experimental | Bilastine Ophthalmic Solution 0.6%
1 drop in each eye at 2 separate times during an 8 day period. Receives: Drug: Bilastine Ophthalmic Solution 0.6% |
| Ketotifen Ophthalmic Solution 0.025% (Zaditen) | Active comparator | Ketotifen Ophthalmic Solution 0.025% (Zaditen)
1 drop in each eye at 2 separate times during an 8 day period. Receives: Drug: Ketotifen Ophthalmic Solution 0.025% (Zaditen) |
| Vehicle of Bilastine Ophthalmic Solution | Placebo comparator | Vehicle of Bilastine Ophthalmic Solution
1 drop in each eye at 2 separate times during an 8 day period. Receives: Drug: Vehicle of Bilastine Ophthalmic Solution |
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 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).
Measured: The outcome measure was assessed at Visit 4b (Day 1: 16h post-treatment) and Visit 5 (Day 8 ±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.
- First posted27 Mar 2018
- Study start7 Apr 2018
- Primary completion9 Aug 2018
- Study completion10 Aug 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faes Farma, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479307
- Sponsor's protocol ID
- BOFT-0218/AC-CAC
- Status last verified
- Nov 2021
- First submitted
- 21 Mar 2018
- 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
Publications
Gomes PJ, Ciolino JB, Arranz P, Hernandez G, Fernandez N. Bilastine 0.6% Preservative-free Eye Drops: A Once-daily Treatment for Allergic Conjunctivitis. J Investig Allergol Clin Immunol. 2024 Jun 17;34(3):167-176. doi: 10.18176/jiaci.0894. Epub 2023 Feb 23.
PubMed 36811846
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 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
- ClinicalTrials.gov ID
- NCT03479307
- Acronym / sponsor ID
- BOFT-0218/AC-CAC
- Conditions
- Allergic Conjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Faes Farma, S.A.Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Study start
- 7 Apr 2018 (actual)
- Primary completion
- 9 Aug 2018 (actual)
- Study completion
- 10 Aug 2018 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Posted 14 Dec 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 0.6% compared to vehicle and Zaditen (Ketotifen ophthalmic solution 0.025%) for the treatment of the signs and symptoms of allergic conjunctivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bilastine Ophthalmic Solution 0.6% | Experimental | Drug: Bilastine Ophthalmic Solution 0.6%Bilastine Ophthalmic Solution 0.6% 1 drop in each eye at 2 separate times during an 8 day period. |
| Ketotifen Ophthalmic Solution 0.025% (Zaditen) | Active comparator | Drug: 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. |
| Vehicle of Bilastine Ophthalmic Solution | Placebo comparator | Drug: Vehicle of Bilastine Ophthalmic SolutionVehicle of Bilastine Ophthalmic Solution 1 drop in each eye at 2 separate times during an 8 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 Ophthalmic Solution 0.6%1 drop in each eye at 2 separate times during an 8 day period. | Drug | Bilastine Ophthalmic Solution 0.6% |
| Ketotifen Ophthalmic Solution 0.025% (Zaditen)Also: Zaditen1 drop in each eye at 2 separate times during an 8 day period. | Drug | Ketotifen Ophthalmic Solution 0.025% (Zaditen) |
| Vehicle of Bilastine Ophthalmic Solution1 drop in each eye at 2 separate times during an 8 day period. | Drug | Vehicle of Bilastine Ophthalmic Solution |
Primary outcome
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).
Results and safety
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.
- Derived from this study: PubMed 36811846Gomes PJ, Ciolino JB, Arranz P, Hernandez G, Fernandez N. Bilastine 0.6% Preservative-free Eye Drops: A Once-daily Treatment for Allergic Conjunctivitis. J Investig Allergol Clin Immunol. 2024 Jun 17;34(3):167-176. doi: 10.18176/jiaci.0894. Epub 2023 Feb 23.
- Individual participant dataSharing planned: No
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bilastine Ophthalmic Solution 0.6% and Ketotifen Ophthalmic Solution 0.025% (Zaditen) in people with Allergic Conjunctivitis, run by Faes Farma, S.A. at 6 sites 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 6 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 14 Dec 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) and Visit 5 (Day 8 ±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 NCT03479307, which also lists 1 linked publication.
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; AzTrials last refreshed its copy on 27 Oct 2026.