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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.

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

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

Other trials in Spain

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).

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 groups in NCT04810390
Study groupRoleWhat they receive
BilastineExperimentalDaily instillation of one drop in each eye of Bilastine ophthalmic solution 0.6% for 8 weeks.
Receives: Drug: Bilastine
PlaceboPlacebo comparatorDaily 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.

  1. 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)

  1. Incidence of treatment-emergent adverse events (TEAEs)

    It will be reported the incidence of treatment-emergent adverse events (TEAEs)

    Measured: 8 weeks

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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.

  1. First posted23 Mar 2021
  2. Study start26 Mar 2021
  3. Primary completion30 Nov 2022
  4. Study completion30 Nov 2022

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT04810390.

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.

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