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A Comparative study of efficacy and safety of Tapcom combination ophthalmic solution and Xalacom combination eye drops.

A Comparative study of efficacy and safety of Tapcom combination ophthalmic solution and Xalacom combination eye drops. - A Comparative study of efficacy and safety of Tapcom combination ophthalmic solution and Xalacom combination eye drops.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023862
Enrollment
150
Registered
2016-09-07
Start date
2016-07-21
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 or ocular hypertension

Interventions

Tapcom combination ophthalmic solution, QD for 12weeks Xalacom combination eye drops, QD for 12weeks

Sponsors

Santen Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who can visit the hospital according to the observation/test schedule determined in the study protocol Those with disease of which the principal investigator or subinvestigator considers requiring treatment by using a fixed dose combination drug containing a prostaglandin and a beta blocker.

Exclusion criteria

Exclusion criteria: There is risk of visual field disorder drastically progressing during the study period. Has retinal which may aggravate during the study period. Has active extraocular disease, inflammation or infection of the eye or eyelids Has corneal abnormalities or other diseases which would prohibit accurate IOP measurement by Goldmann applanation tonometer Has undergone LASIK surgery Patients who are contraindicated to beta blockers (those who with bronchial asthma or insufficiently controlled heart failure) Patients with allergy to the ingredients used in the present study Female who is pregnant, lactating, or may possibly be pregnant , wishes to become pregnant during the study period, or cannot use appropriate contraceptive method.

Design outcomes

Primary

MeasureTime frame
IOP Change from baseline at the end of treatment

Countries

Japan

Contacts

Public ContactNaomi Otsuka

Santen Pharmaceutical Co., Ltd. Japan Medical Affairs, Development Management Department, Japan Business

clinical@santen.co.jp06-4802-9603

Outcome results

None listed

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