A Phase 3 interventional study of Bilastine and Placebo in Allergic Conjunctivitis, sponsored by Faes Farma, S.A.. Completed at 18 sites in Spain. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-03-16.
Sponsored by Faes Farma, S.A. · Phase 3, Interventional, and Treatment
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).
210 studies on the registry are indexed under Conjunctivitis, Allergic; 18 are open to participants now.
This study's enrollment of 59 is below the median of 87 across 174 interventional studies indexed under Conjunctivitis, Allergic.
Browse Conjunctivitis, Allergic studies →Faes Farma, S.A. is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Willing to comply in all aspects of the study, including:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Daily instillation of one drop in each eye of Bilastine ophthalmic solution 0.6% for 8 weeks.
Drug: Bilastine
Daily instillation of one drop in each eye of placebo for 8 weeks.
Drug: Placebo
Ophthalmic solution 0.6%
Ophthalmic solution
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.
Time frame: 8 weeks
Incidence of treatment-emergent adverse events (TEAEs)
It will be reported the incidence of treatment-emergent adverse events (TEAEs)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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.
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
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.
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
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.
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
The average value for both eyes in each single symptom score will be used.
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
The average value for both eyes in each single symptom score will be used.
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
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.
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
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.
Time frame: 8 weeks
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bilastine
Faes Farma, S.A.