Clinical study to evaluate safety and efficacy of two different dosage groups of Tacrosolv eye drops in patients suffering from grass pollen-induced allergic rhinoconjunctivitis.
- Conditions
- Allergic rhinoconjunctivitisMedDRA version: 20.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2019-002847-62-AT
- Lead Sponsor
- Marinomed Biotech AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 107
I1.Written informed consent obtained before any trial related procedures are performed
I2.Healthy male or female subjects aged 18 to 65 years
I3.Female subjects of child-bearing potential must have a negative pregnancy test and be willing to practice appropriate and safe contraceptive methods until the end of treatment visit
I4.A documented clinically relevant allergic history of moderate to severe SAR with rhinoconjunctivitis to grass pollen for the previous two years
I5.Subjects exhibit a moderate to severe response to approximately 1800 grass pollen grains/m3 within the first 2 hours in the Vienna Challenge Chamber, which is defined as total ocular symptom score (TOSS) of at least 4 (out of 12) with at least one single ocular symptom scored =2 (moderate”) at least twice during the first two hours of the screening challenge session using standard VCC grass pollen allergen mixture. Ocular symptom score is the sum of ocular redness”, ocular itching”, watery eyes”, ”gritty feeling” each of which have been scored on a categorical scale from 0 to 3.
I6.Positive Skin Prick Test (SPT) response (wheal diameter at least 3 mm larger than diluent control) to grass pollen SPT solutions (standard Allergopharma) at screening or within the last 12 months prior to study start.
I7.Positive serum specific IgE against recombinant major allergen components of the used grass pollen e.g. g6 (specific CAP IgE =0.70 kU/L) at screening or within the last 12 months prior to study start.
I8.Non-smoking subjects (smoked <10 packs per year in their lifetime and had not smoked in the last 6 months).
I9.Asthma patients only if the asthma condition is mild or intermittent, and if those are not treated with steroids
I10.Subject has a forced expiratory volume in 1 second (FEV1) of at least 80% of predicted value (ECCS) at the screening.
I11.Subject is capable of understanding the study procedures and potential risks associated with the study, and voluntarily agrees to participate by giving written informed consent.
I12.Subject is able to adhere to dose and visit schedules.
I13.Subject is able to read, understand and complete questionnaires and diaries.
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 107
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
E1Pregnant, lactating or sexually active women with childbearing potential who are not using a medically accepted and safe birth control method (pregnancy to be controlled by a pregnancy dipstick test).
E2Contact lens users
E3A clinical history of uncontrolled asthma within 3 months prior to screening.
E4Subjects with asthma requiring treatment with inhaled or oral corticosteroids on a regular basis judged by the investigator.
E5Previous successful immunotherapy to grass pollen, a grass pollen allergen or a cross-reacting allergen within the past 3 years
E6Ongoing treatment with any allergen-specific immunotherapy product
E7Subjects with a current oral candidiasis infection or treatment for oral candidiasis during the last 30 days before starting the study.
E8Subjects with history of tuberculosis.
A subject meeting any of the exclusion criteria listed below must be excluded from participating in the trial:
E1Pregnant, lactating or sexually active women with childbearing potential who are not using a medically accepted and safe birth control method (pregnancy to be controlled by a pregnancy dipstick test).
E2Contact lens users
E3A clinical history of uncontrolled asthma within 3 months prior to screening.
E4Subjects with asthma requiring treatment with inhaled or oral corticosteroids on a regular basis judged by the investigator.
E5Previous successful immunotherapy to grass pollen, a grass pollen allergen or a cross-reacting allergen within the past 3 years
E6Ongoing treatment with any allergen-specific immunotherapy product
E7Subjects with a current oral candidiasis infection or treatment for oral candidiasis during the last 30 days before starting the study.
E8Subjects with history of tuberculosis.
E9Subjects with any fungal/viral/bacterial respiratory or systemic infections during the last 30 days.
E10Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process (at randomization)
E11Subjects with uveitis, prior chemical burn to the ocular surface, pemphigoid, Mooren’s ulcer, ulcerative keratitis, bacterial/fungal/viral infection of the eye
E12Subjects using any ophthalmic steroids during the last 30 days
E13Subjects treated with nasal, inhaled or systemic immunosuppressants during the last 30 days
E14History of anaphylaxis with cardiorespiratory symptoms (immunotherapy, exercise induced, food allergy, drugs or an idiopathic reaction).
E15Any clinically relevant chronic disease judged by the investigator.
E16Systemic or ocular disease involving the immune system judged by the investigator.
E17Use of an investigational drug within 30 days/5 half-lives of the drug (which ever longest) prior to screening.
E18History of allergy, hypersensitivity or intolerance to any ingredients of the IMP.
E19History of alcohol or drug abuse.
E20Being immediate family of the investigator or trial staff, defined as the investigator's/staff’s spouse, parent, child, grandparent or grandchild.
E21Subjects treated with topical anti-allergy or cyclosporin-containing eyedrops within 2 weeks before study start.
E22Subjects treated with leukotriene antagonists (1 month before study start), long-lasting anti-histamines, like cetirizine, fexofenadine, loratadine, desloratadine, hydroxyzine (5 to 10 days before study start), mast cell stabilizer (2 weeks before study start) or nasal decongestant (3 days before study start).
E23Subjects
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method