Subjects presenting moderate allergic conjunctivitis to birch pollen MedDRA version: 20.1 Level: PT Classification code 10010741 Term: Conjunctivitis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: NAABAK
Pharmaceutical Form: Eye drops, solution
Trade Name: FLUCON
Pharmaceutical Form: Eye drops, solution
Sponsors
THEA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adults aged 18-65 years, with moderate manifestations of allergic conjunctivitis with or without allergic rhinitis. • The history of moderate conjunctivitis in the last 2 years according to EAACI recommendations. • Positive Prick tests (papule diameter greater than 6 mm compared to the negative control), • IgE specific to Bet v1 greater than 0.70 kUI / l • Individual conjunctival challenge test positive for birch pollen (Abelson score = 5). 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 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Personal or family history of glaucoma • Eye Hypertension • Eye surgery within 6 months of inclusion in the study • Other forms of allergic conjunctivitis: Vernal and atopic keratoconjunctivitis, giant papillary conjunctivitis, perannual allergic conjunctivitis • Non-specific conjunctival hyperreactivity • Herpetic keratitis • Viral diseases of the cornea and conjunctiva • Tuberculous lesions and untreated bacterial infections of the eye; • Fungal diseases of ocular structures • Affection of the sclera or cornea • Dry eye syndrome • dysimmune diseases that may interfere with the study (dry syndrome in the context of inflammatory rheumatism) • Allergic pathology (rhinitis, conjunctivitis) not controlled • Uncontrolled asthma requiring a short-acting B2 mimetic more than twice a week or requiring that taken within the last 15 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. To evaluate the time required to obtain a positive Abelson score in both subjects groups during an allergen exposure in ALYATEC environmental chamber. 2. To evaluate the onset of conjunctival symptoms during an allergen exposure in ALYATEC environmental chamber. 3. To appreciate the correlation between the dose of allergen required to induce a positive conjunctival provocation unitary test and the dose required to induce a conjunctival response, during an exposure to birch pollen allergen in ALYATEC environmental chamber. ;Main Objective: To evaluate the efficacy of NAABAK® compared to FLUCON®, assessed by the measure of the amount of major birch pollen allergen required to trigger a conjunctival response in subjects presenting moderate symptoms of allergic conjunctivitis caused by birch pollen.;Primary end point(s): • Allergen quantity needed to induce a positive conjunctival response (Abelson score = 5). ;Timepoint(s) of evaluation of this end point: At Expo 1 (D1 + D2) and at Expo 2 (D1 + D2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Time to reach a positive conjunctival response (Abelson score = 5) in both treatments groups 2. Evaluation of the onset of conjunctival symptoms during birch allergens exposures (Abelson score by physician, TOSS and conjunctivitis VAS) 3. Correlation between the the dose of allergen required to induce a positive conjunctival provocation unitary test and the dose required to induce a conjunctival response in the EEC 4. Safety : VEMS measurements;Timepoint(s) of evaluation of this end point: - Abelson score, TOSS and conjunctivitis VAS : every 10 minutes during the first hour, then every 20 minutes for the next 3 hours - VEMS measurements : every 30 minutes during exposures | — |
Countries
France
Contacts
Public ContactChief Operating Officer
ALYATEC
Outcome results
None listed