Primary open-angle glaucoma which is in a limited sense, normal tension glaucoma, primary angle-closure glaucoma, exfoliation glaucoma, or high-tension glaucoma
Conditions
Interventions
Period for administration (observation period):4 weeks Mikelan ophthalmic solution:One drop of once, twice a day Xalatan Eye Drops:One drop of once, once a day at night Period for administration
Sponsors
NITTEN Pharmaceutical co. ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient who satisfies the following all selection criteria. 1) Age:20 years old or more at the time of informed consent acquisition. 2) Gender:No object. 3) Hospital patient or out patient:No object. 4) A patient who is treated with Xalatan Eye Drops and nonselective beta blocker eye drops (containing alpha beta blocker eye drops) or treated with Xalatan Eye Drops, nonselective beta blocker eye drops (containing alpha beta blocker eye drops) and carbonate dehydratase inhibitor eye drops for 3 months (12 weeks) before obtaining informed consent. However, the patient has to switch nonselective beta blocker eye drops (containing alpha beta blocker eye drops) to Mikelan ophthalmic solution 2% during the observation phase of this post marketing clinical study. For a patient using carbonate dehydratase inhibitor eye drops, you have to cease them and keep the intraocular pressure. [Nonselective beta blocker eye drops (containing alpha beta blocker eye drops)] Carteolol hydrochloride eyes drops (1%, 2%) Timolol maleate eyes drops (0.25%, 0.5%) Gelled timolol maleate eyes drops (0.25%, 0.5%) Nipradilol Eyes Drops (0.25%) Levobunolol hydrochloride eyes drops (0.5%) [Carbonate dehydratase inhibitor eye drops)] Dorzolamide hydrochloride eyes drops (0.5%, 1%) Brinzolamid eyes drops (1%) 5) The value of evaluation-intended eye intraocular pressure at the time of the screening test and the baseline test is more than 13mmHg and under 30mmHg. 6) The visual test using Humphrey SITA-Fast or Humphrey SITA-Standard is conducted at the time of the screening test , the MD value of the evaluation-intended eye is more than -15dB . (If the visual test is carried out within 3 months before screening test, the data is acceptable.)
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactAkira Nezaki
NITTEN Pharmaceutical co. ltd. Research and Development Division
Outcome results
None listed