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Evaluation of dorzolamide/timolol fixed-dose combination therapy for the patients who need more IOP (trough & peak) reduction under treatment of PG analogues and beta-blocker

Evaluation of dorzolamide/timolol fixed-dose combination therapy for the patients who need more IOP (trough & peak) reduction under treatment of PG analogues and beta-blocker - Effect of dorzolamide hydrochloride/timolol maleate fixed-dose combination on intraocular pressure (trough & peak)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000006829
Enrollment
20
Registered
2011-12-09
Start date
2011-03-01
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

Glaucoma

Interventions

Sponsors

Hospital, University of the Ryukyus
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 a written information to patients. (2) Patients with glaucoma poorly responding to the treatment of prostaglandins and beta-blocker for more than 2 month (regardless of PG analogues and beta-blocker) (3) Patients aged 20 years or older who are capable of providing consent. (4) Males and females.

Exclusion criteria

Exclusion criteria: "(1) Patients who have undergone an operation (including laser operation) within 3 months before the study. (2) Patients who have difficulty in measuring intraocular pressure using an applanation tonometer. (3) Patients who have difficulty or are unable to undergo fundoscopy (corneal opacity, severe cataract, etc.). (4) Patients expected to require operation for an eye disease during the study period. (5) Patients with serious renal impairment (nephrotic syndrome, acute renal failure, chronic renal failure, etc.) (6) Patients with hepatic function disorder. (7) Patients with bronchial asthma or its history. (8) Patients with bronchospasm or serious chronic obstructive pulmonary disease. (9) Patients with cardiac failure, sinus bradycardia, atrioventricular block (second and third degrees), or cardiogenic shock. (10) Patients with right cardiac failure due to pulmonary hypertension. (11) Patients with congestive cardiac failure. (12) Patients with diabetic ketoacidosis and/or metabolic acidosis. (13) Patients with poorly controlled diabetes mellitus. (14) Patients with a anamnestic history of hypersensitivity to any ingredients of the investigational product. (15)Patients who has received administration of the adrenocortical steroid agent (Skin local administration other than an eye circumference part is good). (16) During a pregnant woman, the nursing or a patient with possibility becoming pregnant. (17) Patients whom it was judged a doctor not to be suitable as an object of the study.

Design outcomes

Primary

MeasureTime frame
Change of intraocular pressure (trough & peak) before and after instillation

Secondary

MeasureTime frame
Safety

Countries

Japan

Contacts

Public ContactYoshikuni Arakaki

Hospital, University of the Ryukyus Department of Ophthalmology

yoshi@med.u-ryukyu.ac.jp098-895-3331

Outcome results

None listed

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