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The efficacy of alternative regimen with dorzolamide/timolol fixed combination for glaucoma patients with combined use of the three separate components (prostaglandin analogue, beta-blocker and carbonic anhydrase inhibitor): a randomized, crossover trial.

The efficacy of alternative regimen with dorzolamide/timolol fixed combination for glaucoma patients with combined use of the three separate components (prostaglandin analogue, beta-blocker and carbonic anhydrase inhibitor): a randomized, crossover trial. - The efficacy of alternative regimen with dorzolamide/timolol fixed combination for glaucoma patients with combined use of the three separate components (prostaglandin analogue, beta-blocker and carbonic anhydrase inhibitor): a randomized, crossover trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000006410
Enrollment
40
Registered
2011-10-01
Start date
2011-10-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary open angle glaucoma exfoliation glaucoma

Interventions

Eye drops of fixed combination of timolol/dorzolamide (twice daily) for 4 weeks. Then eye drops of timolol(once daily) and dorzolamide (three times a day) for 4 weeks. Eye drops of timolol(once daily)

Sponsors

Department of Ophthalmology, Kanazawa University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Written informed consent: Patients capable of providing written consent by themselves after full explanation of the study details using written information to patients. (2) Patients with glaucoma inadequately controlled with combined use of prostaglandins (except for Isopropyl Unoprostone), beta-blocker and CAI for more than 2 months (regardless of PG analogues, beta-blocker and CAI). (3) The level of visual field defect: mean deviation with Humphrey Field Analyzer is less progressive than -15 dB within 6 months before the study. (4) Visual acuity: better than 0.7 in best corrected visual acuity. (5) Patients aged 20 years or older who are capable of providing consent. (6) Males and females.

Exclusion criteria

Exclusion criteria: (1) Pregnant and lactating women, the women who desired of the pregnancy. (2) Patients who have difficulty or are unable to undergo fundoscopy ( severe cataract, etc.). (3) Patients with active external ocular diseases, ocular inflammation or infection. (4) Patients with any corneal abnormality or other condition preventing reliable applanation tonometry. (5) Patients with history of refractive surgery, glaucoma surgery (SLT, trabeculotomy, trabeculectomy etc), vitreous surgery or retinal detachment surgery. (6) Patients with history of surgery for cataract within 3 months before the study. (7) Patients expected to require operation for an eye disease during the study period. (8) Patients with serious renal impairment (nephrotic syndrome, acute renal failure, chronic renal failure, etc.) (9) Patients with hepatic function disorder. (10) Patients with bronchial asthma or its history. (11) Patients with bronchospasm or serious chronic obstructive pulmonary disease. (12) Patients with cardiac failure, sinus bradycardia, atrioventricular block (second and third degrees), or cardiogenic shock. (13) Patients with right cardiac failure due to pulmonary hypertension. (14) Patients with congestive cardiac failure. (15) Patients with diabetic ketoacidosis and/or metabolic acidosis. (16) Patients with poorly controlled diabetes mellitus. (17) Patients with a anamnestic history of hypersensitivity to any ingredients of the investigational product. (18) Patients who has received administration of the adrenocortical steroid agent (except for local skin administration other than around eyes). (19) Patients whom doctor judged to be ineligible for this study.

Design outcomes

Primary

MeasureTime frame
Intraocular pressure

Secondary

MeasureTime frame
Safety

Countries

Japan

Contacts

Public ContactEiji Murotani

Kanazawa University Department of Ophthalmology

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026