Efficacy of epinastine hydrochloride ophthalmic solution in the patients with allergic conjunctivitis after treating with olopatadine hydrochloride ophthalmic solution.

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000016271
• Date of registration: 30/01/2015
• Prospective Registration: No
• Primary sponsor: Mihara eye clinic, medical corporation houjinkai
• Public title: Efficacy of epinastine hydrochloride ophthalmic solution in the patients with allergic conjunctivitis after treating with olopatadine hydrochloride ophthalmic solution.
• Scientific title: Efficacy of epinastine hydrochloride ophthalmic solution in the patients with allergic conjunctivitis after treating with olopatadine hydrochloride ophthalmic solution. - Efficacy of epinastine hydrochloride ophthalmic solution in the patients with allergic conjunctivitis.
• Date of first enrolment: 2014/12/12
• Target sample size: 50
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018881
• Study type: Interventional
• Study design: Single arm Non-randomized
• Phase: Not applicable

Countries of recruitment

Japan

Contacts

• Name: Kenichi Mihara
• Affiliation: Mihara eye clinic, medical corporation houjinkai Mihara eye clinic,

• Name: Kenichi Mihara
• Affiliation: Mihara eye clinic, Mihara eye clinic,

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1) Patients given immunotherapy (hyposensitization therapy, modulated therapy). 2) Patients with ocular pruritus and hyperemia caused by a disease other than allergic conjunctivitis which will influence drug evaluation. 3) Patients with a history of atopic keratoconjunctivitis, spring catarrh, giant papillary conjunctivitis, corneal herpes, recurrent corneal erosion caused by the frequent occurrence of corneal injury or dry eye. 4) Patients with surgical history in the internal eye (including laser therapy) within 90 days prior to initiation of the clinical research. 5) Patients with possibility taking medicines (including anti-allergic agent, immunosuppressive drugs and adrenal cortex steroid except eye drops) which affect the efficacy of study drug. However, the use of ophthalmic solutions of adrenal cortex steroid is admitted as needed if there is no improvement in symptoms. 6) Females who are or may be pregnant, or lactating 7) Patients with a history of hypersensitivity to study drug or test material. 8) Patients with severe complications (such as immediate hospitalized care is required) which are identified inappropriate for safety reason. 9) Patients who have any other reasons that causes the study doctor to deem a subject unsuitable for the study.

Age minimum: 6years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Allergic conjunctivitis

Intervention(s)

Epinastine hydrochloride ophthalmic solution, apply 1 drop a time, 4 times daily, in the both eyes.

Primary Outcome(s)

Percentage of patients with improved symptoms, Change in scores of subjective symptoms(at visits), Change in scores of objective findings(at visits)

Secondary Outcome(s)

Change in scores of subjective symptoms(in patient diary), compliance status, change of value in questionnaire items

Source(s) of Monetary Support

Santen Pharmaceutical Co., Ltd.

Ethics review

Status: YES
Approval date:
Contact:

Results

• Results available: Yes
• Date Completed: 30/04/2015