Allergic Conjunctivitis (AC) MedDRA version: 20.0 Level: LLT Classification code 10001709 Term: Allergic conjunctivitis System Organ Class: 100000004853
Conditions
Interventions
Product Name: Bilastine ophthalmic solution 0.6%
Pharmaceutical Form: Eye drops, solution in single-dose container
INN or Proposed INN: BILASTINE
CAS Nu
Sponsors
FAES FARMA S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18 years and above. 2. Documented history of AC before V1a. 3. Documented positive skin prick test and/ or positive validated IgE test to perennial allergen (e.g. cat dander, dog dander, dust mites and/or cockroach) or to seasonal allergen (e.g. grass, ragweed, and/ or tree pollen) 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 on an 11-item numeric rating scale in at least one of three categories at V1a and V2a. 5. Compliant use of e-diary during the screening period (from V1a to V2a). 6. Willing to comply in all aspects of the study, including a) use of IMP from V2a to V4a b) attending scheduled visits and completing telephone interviews. 7. Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 270 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. History of known contraindications or sensitivities to the use of the IMP or any of its components. 2. History of intraocular surgery 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. 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. 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 IMP (starting at V2a). 12. Wearing of contact lenses during study participation. 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. For women: Pregnancy or breast-feeding. Women of childbearing potential unable or unwilling to undergo pregnancy test(s) and practice acceptable contraceptive measures. Acceptable methods for women are surgical intervention (e.g. bilateral tubal occlusion), spermicide with barrier, oral contraceptive, injectable or implantable method of contraception, transdermal contraceptive, intrauterine device, true sexual abstinence (i.e. when this is in line with the preferred and usual lifestyle of the patient) and vasectomised male partner, provided that he is the sole partner of that patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 16. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to assess the safety of bilastine ophthalmic solution 0.6% during long-term use.; Secondary Objective: 1. To assess the ocular tolerability and potential discomfort of bilastine ophthalmic solution 0.6% during long-term use 2. To assess the efficacy of bilastine ophthalmic solution 0.6% ;Primary end point(s): Incidence of related treatment-emergent ocular adverse events (ocular r-TEAEs);Timepoint(s) of evaluation of this end point: all ocular r-TEAEs throughout the 8 week treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A) Secondary safety endpoints 1. Incidence of treatment-emergent adverse events (TEAEs) 2. Incidence of treatment-emergent ocular adverse events (ocular TEAEs) 3. Incidence of related treatment-emergent adverse events (r-TEAEs) 4. Clinical findings from ophthalmic examinations after instillation of IMP Ophthalmic examination will consist of: • Best-corrected visual acuity test • Slit-lamp biomicroscopy • Intraocular pressure • Dilated fundus examination 5. Peak ocular discomfort score after on-site instillation of IMP 6. Ocular burning, stinging, tearing, blurring, and stickiness after on-site instillation of IMP 7. Safety laboratory tests (haematology, biochemistry, [hCG in women of childbearing potential]) B) Secondary efficacy endpoints 8. 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 9. Absolute value as well as absolute and relative changes from baseline of average daily TESS at each week of the 8-week treatment period 10. 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 11. 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 12. For SAC patients only, the average daily TESS over the 2-week period of peak total eye symptoms score 13. For SAC patients only, the average daily itching, redness and tearing scores over the 2-week period of peak symptoms score ;Timepoint(s) of | — |
Countries
Hungary, Lithuania, Poland, Slovakia, Ukraine
Contacts
Public ContactR&D+i Department
FAES FARMA S.A.
Outcome results
None listed