Effectiveness of Olopatadine HCl Ophthalmic Solution, 0.1% Compared to Epinastine HCl Ophthalmic Solution, 0.05% in the Treatment of Allergic Conjunctivitis to Japanese Cedar Polle

Phase 4

• Conditions: Allergic Conunctivitis

• Registration Number: JPRN-UMIN000013943
• Lead Sponsor: Alcon Japan Ltd.

Brief Summary

In conclusion, the results of this study suggest that olopatadine 0.1% is more effective than epinastine 0.05% at reducing the symptoms of Japanese cedar pollen-induced allergic conjunctivitis in CAC tests, a short-term efficacy evaluation system. Prospective randomized controlled trials in real-life settings are needed to confirm these results and the efficacy and safety of longer term administration of olopatadine.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2014-01-26
• Study Start: 2014-05-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified