subjects with a clinical history of seasonal allergic conjunctivitis, but asymptomatic and free of any topical or systemic medication at baseline MedDRA version: 6.1 Level: PT Classification code 10010744
Conditions
Interventions
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: RUBIDIO IODURO
CAS Number: 7790-29-6
Concentration unit: µg microgram(s)
Concentration type: equal
INN or Proposed INN: POTASSIO IODURO F
Sponsors
ALCON ITALIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men or women of any race, at least 18 year old with a clinical history of seasonal allergic conjunctivitis must be able to undrstand and sign an informed consent that has been approved by a local Ethical Committee must be able and willing to follow instructions to make the required study visits, be willing to avoid disallowed medications i.e. H1-antihistamines, mast-cell stabilizers and corticosteroids and wearing of contact lenses for 3 days prior to and of duration of the study must manifest succesful allergen challange reaction significant clinical reaction is defined as greater or equal to 2 ocular redness in any vessel bed bilaterally at at both Visit 1 and Visit 2 must have positive skin rest results wheal diameter greater than 3 or positive specific serum IgE must have a calculated LogMAR visula acuity score using the ETDRS chart of 0,60 or better in each eye 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: have controindications or known allergy to the test article s or their component be a pregnant or nursing women; or women who have a positive urine pregancy test or women of childbearing potential who refuse to use adeguate hormonal or mechanical means of birth control oral, implantable, topical or injectible contrapcetives, sperimicide with barrier or IUD . For non sexually active females, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the study, she must agree to use adequate birth control methods as defined previously for the remainder of the study have a positive diagnosis of dry eye syndrome requiring use of artificila tears substitute or have insufficient tear volume use medication that may interfere with the study parameters i.e. H1-antihistamines, maust cell stabilizers, corticosteroids etc within 72 hours before Visit 1 or anytime during the study, and wear contac lenses 3 days prior to and during the study have any ocular condition i.e. active bacterial or viral ocular infection, clinically significant blepharitis, follicular conjunctivitis, uveitis or any significant ilness i.e. any autoimmune disease, severe cardiovascular disease including arrhythmia, poorly controlled hypertension or poorly contyrolled diabetes that could be expected to interfere with the study parameters have a history or evidence of ocular surgery within the past 2 monthes manifest ocular signs or symptoms of clinically active allergic conjunctivitis in either eye at the start of Visit 1, 2 or 3 redness gretar than 1 and/or itching greater than 0 used of any investigational drug or device within 30 days of the start of the study or during the study period subjects with only one eye sighted eye or with visual acuity not correctable to 0,6 logMAR or better in both eyes history of moderate to severe asthasma reactions to the allergens that the subject will be challanged with
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the conjunctival mast-cell stabilizing effects on the histamine release of Olopatadine 1 mg/ml Opatanol eye drops using the Conjunctival Allergen Challange Model CAC model ;Secondary Objective: N/A;Primary end point(s): to demonstrate the superiority of olopatadine relative to controlateral placebo arm in decreasing tear histamine level collected within 10 minutes post-CAC after 5 days of treatment Visit3 | — |
Countries
Italy
Outcome results
None listed