NCT04810390CompletedPhase 3
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Faes Farma, S.A.
- Enrollment
- 59
- Locations
- 18
- Primary Endpoint
- Incidence of related ocular treatment-emergent adverse events (ocular r-TEAEs)
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 2 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female patients from 2 to under 18 years of age at V1a.
- •Documented history of AC before V1a.
- •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.
- •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.
- •Understanding of functioning and willingness to use e-diary at V1b and throughout study duration.
- •Willing to comply in all aspects of the study, including:
- •use of IMP from V1b to V5a
- •attending scheduled visits and completing telephone interviews.
- •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.
- •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.
- •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.
Exclusion Criteria
- •History of known contraindications or sensitivities to the use of the IMPs or any of their components.
- •History of intraocular surgery within the previous 2 years before V1a, or planned surgery during study participation and within 2 weeks after follow-up.
- •History of ocular trauma (within the previous 6 months before V1a).
- •History or clinical evidence of ocular herpes simplex or ocular herpes zoster infectious disease within the previous year before V1a.
- •History of any clinically significant external ocular disease within 30 days before V1a.
- •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.
- •Known history of recurrent corneal erosion syndrome (idiopathic or secondary to dry eye).
- •History of treatment failure to topical antihistamines.
- •Prior (within 2 years before V1a), current or anticipated anti-allergy immunotherapy.
- •Prior (within 4 weeks before V1a), current or anticipated corticosteroid treatment (systemic or local, in case of depot-corticosteroids: within 6 weeks before V1a).
- •Prior (within 1 week before V1a), current or anticipated use of any ophthalmic agents (including artificial tears), except IMPs (starting at V1b).
- •Wearing of contact lenses 24 hours before ophthalmologic tests (V1a) and during clinical trial participation until V
- •Prior (within 2 weeks before V1a), current or anticipated systemic or intranasal treatment for allergic rhinitis.
- •Persons committed to an institution by virtue of an order issued either by the judicial or other authorities.
- •Pregnant woman, breastfeeding woman or woman planning a pregnancy.
- •Body weight below the 5th percentile for their age (patients 10 years of age or younger only).
- •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.
- •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).
Arms & Interventions
Bilastine
Experimental
Daily instillation of one drop in each eye of Bilastine ophthalmic solution 0.6% for 8 weeks.
Intervention: Bilastine (Drug)
Placebo
Placebo Comparator
Daily instillation of one drop in each eye of placebo for 8 weeks.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Mean ocular burning, stinging, tearing, blurring and stickiness scores after on-site instillation of IMP(8 weeks)
- Mean peak ocular discomfort score after on-site instillation of IMP(8 weeks)
- Incidence of related treatment-emergent adverse events (r-TEAEs)(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(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(8 weeks)
- Incidence of ocular treatment-emergent adverse events (ocular TEAEs)(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(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(8 weeks)
- Incidence of treatment-emergent adverse events (TEAEs)(8 weeks)
- Incidence of abnormal clinical findings from ophthalmic examinations after instillation of IMP(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(8 weeks)
- For seasonal allergic conjunctivitis (SAC) patients only, the average daily TESS over the 2-week period of peak total eye symptoms score(8 weeks)
Investigators
Study Sites (18)
Loading locations...
Similar Trials
Terminated
Phase 3
Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis BronchiectasisNon-cystic Fibrosis BronchiectasisNCT05006573AstraZeneca100
Recruiting
Phase 3
Outcome Research to Confirm the Anti-anginal Effect of T89 in Patients With Stable AnginaChronic Stable Angina PectorisNCT03789552Tasly Pharmaceuticals, Inc.765
Completed
Phase 3
A Study to Evaluate the Efficacy and Safety of Ensifentrine for 24 Weeks in Patients With Moderate to Severe Chronic Obstructive Pulmonary DiseaseChronic Obstructive Pulmonary DiseaseNCT05743075Nuance Pharma (shanghai) Co., Ltd526
Completed
Phase 3
Study of Efficacy and Safety of Omalizumab in Refractory Chronic Spontaneous Urticaria PatientsChronic Spontaneous UriticariaNCT02329223Novartis Pharmaceuticals218
Completed
Phase 3
Evaluation of the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose IntoleranceLactose IntoleranceNCT03597516Ritter Pharmaceuticals, Inc.557