Allergic Conunctivitis
Conditions
Interventions
A group: Left eye: Olopatadine HCl ophthalmic solution 0.1% Right eye: Epinastine HCl ophthalmic solution, 0.05%
B group: Left eye: Epinastine HCl ophthalmic solution, 0.05%
Sponsors
Alcon Japan Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients MUST: 1. be male or female, at least 20 years of age; 2. be Japanese and living in Japan; 3. have the ability to follow study instructions and be likely to complete all required visits; 4. have a history of allergic conjunctivitis and have a positive skin test reaction to Japanese Cedar allergen at Visit 1; 5. have a positive bilateral CAC reaction (>2 itching and >2 hyperemia in the conjunctival vessel bed) within 10 minutes of instillation of the last titration of allergen at Visit 1; 6. have a positive bilateral CAC reaction ( >2 itching at the 5-minute timepoint and for at least one of the 7- or 15- minute timepoints, and >2 hyperemia in the conjunctival vessel bed for at least 2 of the 3 timepoints) at Visit 2; 7. be able and willing to avoid all disallowed medications for the appropriate washout periods and during the study (see exclusion 10); 8. be able to discontinue wearing any contact lenses during the study period, starting at least 5 days prior to Visit 1; 9. for females of childbearing potential, be using a reliable means of contraception; 10. provide written informed consent and documentation in accordance with the relevant country and local privacy requirements (where applicable) prior to participation into the study.
Exclusion criteria
Exclusion criteria: 1.have a history of allergic hypersensitivity or known hypersensitivity to any compound or chemical class related to the drug being studied or its excipients used in this trial 2. have the presence of any ocular condition that, could affect the patients safety or study parameters 3. have a known history of vernal keratoconjunctivitis and/or atopic keratoconjunctivitis; 4. have had ocular surgical intervention within 3 months prior to Visit 1 and/or a history of refractive surgery within 6 months prior to Visit 1;5. have any presence of active ocular infection or preauricular lymphadenopathy, or positive history of an ocular herpetic infection at any time prior to Visit 3; 6. have any uncontrolled systemic disease; 7. have a history of status asthmaticus, a known history of persistent moderate or severe asthma, or a known history of moderate to severe allergic asthmatic reactions to study allergen(s);8. manifest signs or symptoms of clinically active allergic conjunctivitis in either eye; 9. be a female who is currently pregnant, nursing, or planning a pregnancy; 10. use any of the disallowed medications during the study period; aspirin containing products: discontinue 72 hours; H1-antagonist antihistamines and all other anti-allergy therapies : discontinue 72 hours ; all other topical ophthalmic preparations other than study drops : discontinue 72 hours; corticosteroids or mast cell stabalizers: discontinue 14 days; depot corticosteroids: discontinue 6 months 11. have a planned surgery during the trial period or within 30 days after completion; 12. have current enrollment in an investigational drug or device study or administration of investigational drug in such a study within 30 days of entry into this study; 13.have a condition or be in a situation in the investigators opinion that may put the patient at significant risk,may confound the study results, or may interfere significantly with the patients participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ocular itching will be evaluated by asking patients to provide a numerical rating of ocular itching for each eye at 7 minutes post allergen challenge at Visit 3. Ratings are made on a scale of 0 to 4, allowing half unit increments. | — |
Secondary
| Measure | Time frame |
|---|---|
| Conjunctival hyperemia evaluated by the investigator based on biomicroscopy for each eye at 20 minutes post allergen challenge at Visit 3. | — |
Countries
Japan
Contacts
Public ContactSakaguchi Hironari
Alcon Japan Ltd. PhaseIV Development Medical Affairs
Outcome results
None listed