Allergic ConjunctivitisPhase 3NCT04810390
Study to Assess the Safety, Tolerability and Efficacy of Bilastine Ophthalmic Solution 0.6% in Children
A Phase 3 study testing Bilastine in people with Allergic Conjunctivitis, run by Faes Farma, S.A. at 18 sites in Spain.
Trial summary
This is a multi-centre, randomised, double blind, placebo-controlled, parallel-group, phase III study to assess the safety, tolerability and efficacy of Bilastine ophthalmic solution 0.6% in children with a documented history of seasonal allergic conjunctivitis (SAC) or perennial allergic conjunctivitis (PAC). Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- Bilastine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 18 sitesSpain
- Study dates
- 26 Mar 2021to 30 Nov 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1. Male or female patients from 2 to under 18 years of age at V1a.
- 2. Documented history of AC before V1a.
- 3. Documented positive skin prick test and/or positive validated IgE test to seasonal (e.g. grass, ragweed, and/ or tree pollen) and/or perennial allergen (e.g. cat dander, dog dander, dust mites and/ or cockroach) within 6 months before V1a or a positive skin prick test at V1a.
- 4. Signs and symptoms of AC, i.e. tearing, itching and redness, that are likely to continue for the next weeks. Minimum score of four (in at least one eye) on an 11-item numeric rating scale in at least one of three categories at V1a.
- 5. Understanding of functioning and willingness to use e-diary at V1b and throughout study duration.
- 6. Willing to comply in all aspects of the study, including:
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- use of IMP from V1b to V5a
- attending scheduled visits and completing telephone interviews.
- 7. Signed age-appropriate assent form (in participants 12 years of age and older) and written informed consent by the LAR in all cases. If a patient turns 18 years old during the clinical trial, a new written informed consent form will be provided and signed by the patient if he/she is willing to continue participating in the study.
- 8. Be able to self-administer eye drops satisfactorily or have a caregiver or LAR routinely available for this purpose. If a caregiver or LAR will be in charge of administering eye drops then he/she must attend Visit 1b, in order to be trained for administration of eye drops on-site.
- 9. For females of childbearing potential only: willingness to perform pregnancy tests, acceptance to use highly effective methods of birth control throughout the study duration. Highly effective methods of birth control include: combined hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner (provided that partner is the sole sexual partner of the clinical trial participant and has documentation of azoospermia) or sexual abstinence (if defined as refraining from heterosexual intercourse during the entire period of risk associated with the clinical trial treatment). The investigator is responsible for determining whether the subject has adequate birth control for study participation.
Who cannot join
- 1. History of known contraindications or sensitivities to the use of the IMPs or any of their components.
- 2. History of intraocular surgery within the previous 2 years before V1a, or planned surgery during study participation and within 2 weeks after follow-up.
- 3. History of ocular trauma (within the previous 6 months before V1a).
- 4. History or clinical evidence of ocular herpes simplex or ocular herpes zoster infectious disease within the previous year before V1a.
- 5. History of any clinically significant external ocular disease within 30 days before V1a.
- 6. Presence of dry eye, active blepharitis, active Meibomian gland dysfunction, active rosacea affecting the ocular surface/ lid margin, active or chronic follicular conjunctivitis, preauricular adenopathy, or any other ocular or periocular abnormality that may affect study outcome at V1a.
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- 7. Known history of recurrent corneal erosion syndrome (idiopathic or secondary to dry eye).
- 8. History of treatment failure to topical antihistamines.
- 9. Prior (within 2 years before V1a), current or anticipated anti-allergy immunotherapy.
- 10. Prior (within 4 weeks before V1a), current or anticipated corticosteroid treatment (systemic or local, in case of depot-corticosteroids: within 6 weeks before V1a).
- 11. Prior (within 1 week before V1a), current or anticipated use of any ophthalmic agents (including artificial tears), except IMPs (starting at V1b).
- 12. Wearing of contact lenses 24 hours before ophthalmologic tests (V1a) and during clinical trial participation until V6.
- 13. Prior (within 2 weeks before V1a), current or anticipated systemic or intranasal treatment for allergic rhinitis.
- 14. Persons committed to an institution by virtue of an order issued either by the judicial or other authorities.
- 15. Pregnant woman, breastfeeding woman or woman planning a pregnancy.
- 16. Body weight below the 5th percentile for their age (patients 10 years of age or younger only).
- 17. Patient has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before V1a or is currently enrolled in an investigational interventional study.
- 18. Any condition that, in the opinion of the investigator, may jeopardise the clinical trial conduct according to the protocol. (For example, evidence of diseases, medications or laboratory abnormalities that could alter the conduct of the study).
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Spain18 sites
Instituto Oftálmologico Quironsalud A Coruña
A Coruña
Hospital Universitari German Trias i Pujol (HGTiP),
Badalona
Hospital Universitario de Cruces
Barakaldo, Bizkaia, 48903
Hospital Universitari Dexeus
Barcelona
Hospital Universitari Vall D'Hebron
Barcelona
Hospital General La Mancha Centro
Ciudad Real
Clínica Universidad de Navarra (CUN)- Sede Madrid
Madrid
Hospital Universitario Quirónsalud Madrid
Madrid
Hospital Quirónsalud Málaga
Málaga
Hospital Quirónsalud Marbella
Marbella
Hospital Universitario Central de Asturias
Oviedo
Clínica Juaneda
Palma de Mallorca
Clínica Universidad de Navarra
Pamplona
Hospital Universitario Donostia
San Sebastián
Hospital de Dia Quirónsalud Ave María
Seville
Hospital Quirón Valencia
Valencia
Hospital Universitario Dr. Peset Aleixandre
Valencia
Hospital Universitario Araba
Vitoria-Gasteiz
About this study
Official title: Multi-centre, Randomised, Double Blind, Placebo-controlled, Parallel, Phase III Study to Assess the Safety, Tolerability and Efficacy of Bilastine Ophthalmic Solution 0.6% in Children
This is a multi-centre, randomised, double blind, placebo-controlled, parallel-group, phase III study to assess the safety, tolerability and efficacy of Bilastine ophthalmic solution 0.6% in children with a documented history of seasonal allergic conjunctivitis (SAC) or perennial allergic conjunctivitis (PAC).
- Conditions
- Allergic Conjunctivitis
- Being tested
- Bilastine, Placebo
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BilastineDrug
Ophthalmic solution 0.6%
PlaceboDrug
Ophthalmic solution
| Study group | Role | What they receive |
|---|---|---|
| Bilastine | Experimental | Daily instillation of one drop in each eye of Bilastine ophthalmic solution 0.6% for 8 weeks. Receives: Drug: Bilastine |
| Placebo | Placebo comparator | Daily instillation of one drop in each eye of placebo for 8 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of related ocular treatment-emergent adverse events (ocular r-TEAEs)
It will be reported the incidence of related ocular treatment-emergent adverse events (ocular r-TEAEs) as primary safety endpoint.
Measured: 8 weeks
Secondary outcomes (12)
Incidence of treatment-emergent adverse events (TEAEs)
It will be reported the incidence of treatment-emergent adverse events (TEAEs)
Measured: 8 weeks
Incidence of ocular treatment-emergent adverse events (ocular TEAEs)
It will be reported the incidence of ocular treatment-emergent adverse events (ocular TEAEs)
Measured: 8 weeks
Incidence of related treatment-emergent adverse events (r-TEAEs)
It will be reported the incidence of related treatment-emergent adverse events (r-TEAEs)
Measured: 8 weeks
Incidence of abnormal clinical findings from ophthalmic examinations after instillation of IMP
It will be reported the incidence of abnormal clinical findings from ophthalmic examinations after instillation of IMP.
Ophthalmic examination will consist of:
- Best-corrected visual acuity test with age-appropriate techniques
- Slit lamp biomicroscopy
- Intraocular pressure in children who can cooperate with the test and do not require general anaesthesia
- Non-dilated fundus examination
Measured: 8 weeks
Mean peak ocular discomfort score after on-site instillation of IMP
Potential peak ocular discomfort caused by IMPs will be evaluated separately for each eye by the patient, with the aid of LAR if required, immediately upon instillation, on an 11-item numeric rating scale (from 0 to 10), which will include age-appropriate visual scales for children.
Measured: 8 weeks
Mean ocular burning, stinging, tearing, blurring and stickiness scores after on-site instillation of IMP
Ocular tolerability (burning, stinging, tearing, blurring, and stickiness) of IMPs will be assessed separately for each eye by the patient with the aid of LAR if required,on an 11-item numeric rating scale (from 0 to 10), which will include age-appropriate visual scales for children.
Measured: 8 weeks
Absolute value as well as absolute and relative changes from baseline of average daily total eye symptoms score (TESS) over the entire 8-week treatment period
The total eye symptoms score (TESS) based on the patient's e-diary is defined as the sum of the ocular itching, redness, and tearing scores. For each patient the worst daily sum of ratings will be selected for analysis. Additional exploratory analyses will be performed for each ocular symptom using the mean results of both eyes.
Measured: 8 weeks
Absolute value as well as absolute and relative changes from baseline of average daily TESS at each week of the 8-week treatment period
The total eye symptoms score (TESS) based on the patient's e-diary is defined as the sum of the ocular itching, redness, and tearing scores. For each patient the worst daily sum of ratings will be selected for analysis. Additional exploratory analyses will be performed for each ocular symptom using the mean results of both eyes.
Measured: 8 weeks
Absolute value as well as absolute and relative changes from baseline of average daily itching, redness and tearing scores over the entire 8-week treatment period
The average value for both eyes in each single symptom score will be used.
Measured: 8 weeks
Absolute value as well as absolute and relative changes from baseline of average daily itching, redness and tearing scores at each week of the 8-week treatment period
The average value for both eyes in each single symptom score will be used.
Measured: 8 weeks
For seasonal allergic conjunctivitis (SAC) patients only, the average daily TESS over the 2-week period of peak total eye symptoms score
For SAC patients, the average daily TESS and single symptom scores over the 2-week period of peak TESS and the 2-week period of peak single symptom scores, respectively, will be analysed using ANOVA.
Measured: 8 weeks
For seasonal allergic conjunctivitis (SAC) patients only, the average daily itching, redness and tearing scores over the 2-week period of peak symptoms score
For SAC patients,the average daily itching, redness and tearing scores over the 2-week period of peak symptoms scores, respectively, will be analysed using ANOVA.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start26 Mar 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faes Farma, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dynamic Science S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810390
- Sponsor's protocol ID
- BOFT-0520/PED
- Status last verified
- Jul 2022
- First submitted
- 1 Mar 2021
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Multi-centre, Randomised, Double Blind, Placebo-controlled, Parallel, Phase III Study to Assess the Safety, Tolerability and Efficacy of Bilastine Ophthalmic Solution 0.6% in Children
- ClinicalTrials.gov ID
- NCT04810390
- Acronym / sponsor ID
- BOFT-0520/PED
- Conditions
- Allergic Conjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Faes Farma, S.A.Industry (pharma, biotech, devices)
- Collaborators
- Dynamic Science S.L.
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-centre, randomised, double blind, placebo-controlled, parallel-group, phase III study to assess the safety, tolerability and efficacy of Bilastine ophthalmic solution 0.6% in children with a documented history of seasonal allergic conjunctivitis (SAC) or perennial allergic conjunctivitis (PAC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilastine | Experimental | Drug: BilastineDaily instillation of one drop in each eye of Bilastine ophthalmic solution 0.6% for 8 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboDaily instillation of one drop in each eye of placebo for 8 weeks. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 1. Male or female patients from 2 to under 18 years of age at V1a.
- 2. Documented history of AC before V1a.
- 3. Documented positive skin prick test and/or positive validated IgE test to seasonal (e.g. grass, ragweed, and/ or tree pollen) and/or perennial allergen (e.g. cat dander, dog dander, dust mites and/ or cockroach) within 6 months before V1a or a positive skin prick test at V1a.
- 4. Signs and symptoms of AC, i.e. tearing, itching and redness, that are likely to continue for the next weeks. Minimum score of four (in at least one eye) on an 11-item numeric rating scale in at least one of three categories at V1a.
- 5. Understanding of functioning and willingness to use e-diary at V1b and throughout study duration.
Key exclusion criteria (18 listed)
- 1. History of known contraindications or sensitivities to the use of the IMPs or any of their components.
- 2. History of intraocular surgery within the previous 2 years before V1a, or planned surgery during study participation and within 2 weeks after follow-up.
- 3. History of ocular trauma (within the previous 6 months before V1a).
- 4. History or clinical evidence of ocular herpes simplex or ocular herpes zoster infectious disease within the previous year before V1a.
- 5. History of any clinically significant external ocular disease within 30 days before V1a.
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 |
|---|---|---|
| BilastineOphthalmic solution 0.6% | Drug | Bilastine |
| PlaceboOphthalmic solution | Drug | Placebo |
Primary outcome
Incidence of related ocular treatment-emergent adverse events (ocular r-TEAEs)
Time frame: 8 weeks
It will be reported the incidence of related ocular treatment-emergent adverse events (ocular r-TEAEs) as primary safety endpoint.
12 secondary outcomes
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: 8 weeks
Incidence of ocular treatment-emergent adverse events (ocular TEAEs)
Time frame: 8 weeks
Incidence of related treatment-emergent adverse events (r-TEAEs)
Time frame: 8 weeks
Incidence of abnormal clinical findings from ophthalmic examinations after instillation of IMP
Time frame: 8 weeks
Mean peak ocular discomfort score after on-site instillation of IMP
Time frame: 8 weeks
Mean ocular burning, stinging, tearing, blurring and stickiness scores after on-site instillation of IMP
Time frame: 8 weeks
Absolute value as well as absolute and relative changes from baseline of average daily total eye symptoms score (TESS) over the entire 8-week treatment period
Time frame: 8 weeks
Absolute value as well as absolute and relative changes from baseline of average daily TESS at each week of the 8-week treatment period
Time frame: 8 weeks
Absolute value as well as absolute and relative changes from baseline of average daily itching, redness and tearing scores over the entire 8-week treatment period
Time frame: 8 weeks
Absolute value as well as absolute and relative changes from baseline of average daily itching, redness and tearing scores at each week of the 8-week treatment period
Time frame: 8 weeks
For seasonal allergic conjunctivitis (SAC) patients only, the average daily TESS over the 2-week period of peak total eye symptoms score
Time frame: 8 weeks
For seasonal allergic conjunctivitis (SAC) patients only, the average daily itching, redness and tearing scores over the 2-week period of peak symptoms score
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
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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.
18 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 in people with Allergic Conjunctivitis, run by Faes Farma, S.A. at 18 sites in Spain.
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 11 inclusion and 18 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 18 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of related ocular treatment-emergent adverse events (ocular r-TEAEs) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2026.