The study of having an inhibitory effect on occuring ocular surface disorders of Blokyleate PF ophthalmic solution 2% in a glaucomatous eye -Controlled trial with Mikelan ophthalmic solution 2%

Phase 4

• Conditions: Primary open-angle glaucoma which is in a limited sense, normal tension glaucoma, primary angle-closure glaucoma, exfoliation glaucoma, or high-tension glaucoma

• Registration Number: JPRN-UMIN000003214
• Lead Sponsor: ITTEN Pharmaceutical co. ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-19
• Study Completion: 2010-06-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

At the time of informed consent acquisition and the baseline test, a patient corresponding to any of the following criterion is excluded. 1) A patient putting contact lens on the evaluation-intended eye. 2) A patient whose best-corrected visual acuity on the evaluation-intended eye is under 0.5. 3) A patient having eye disorder except for cataract and ametropia on the evaluation-intended eye. (However, the following 4)-12) are considered.) 4) A patient complicating chronic or recurrent inflammatory disorder (uveitis, scleritis, corneal herpes, and so on) on the evaluation-intended eye. 5) A patient complicating eye disorder, such as retinal degeneration, retinopathy of diabetes, allergic conjunctival disease and so on, which is judged as ineligibility for enrollment by an investigator, on the evaluation-intended eye. 6) A patient complicating infections on the evaluation-intended eye. 7) A patient having the history of glaucoma surgery on the evaluation-intended eye. (Except for the following laser surgery which is conducted before more than 3 months (12 weeks) obtaining the informed consent.) Laser iridotomy, laser trabeculoplasty and laser angleplasty. 8) A patient having the history of intraocular surgery on the evaluation-intended eye within 3 months (12 weeks)before obtaining the informed consent. 9) A patient having the history of ophthalmologic laser surgery on the evaluation-intended eye within 3 months (12 weeks) before obtaining the informed consent. 10) A patient having the history of ocular injury on the evaluation-intended eye within 3 months (12 weeks) before obtaining the informed consent. 11) A patient having the severe kerato- conjunctiva epithelium disorder (persistent epithelial defect, corneal erosion, and so on) on the evaluation-intended eye. 12) A patient interfering with applanometry on the evaluation-intended eye. 13) A patient having carteolol hydrochloride sensitivity. Other 11 items.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The following scoring of kerato- conjunctival epithelium disorder at baseline test and 12th week of the treatment phase. (1) Fluorescein stain score (0 to 3: 3 regions) (2) Rosebengal stain score (0 to 3: 3 regions)

Secondary Outcome Measures

Name	Time	Method
The following scoring of a kerato- conjunctival epithelium disorder at baseline test, 4th week and 8th week of the treatment phase. (1) Fluorescein stain score (0 to 3: 3 regions) (2) Rosebengal stain score (0 to 3: 3 regions) The value of an intraocular pressure at baseline test, 4th week, 8th week and 12th week / cutoff point of the treatment phase.