Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma

Alcon

Status and phase

Completed

Phase 4

Conditions

Ocular Hypertension

Normal Tension Glaucoma

Treatments

Drug: Travoprost Ophthalmic Solution 0.004%

Study type

Interventional

Funder types

Industry

Identifiers

NCT01995136

UMIN000011621 (Registry Identifier)

M-13-047

Details and patient eligibility

About

The purpose of this study is to investigate IOP reduction efficacy of travoprost 0.004% ophthalmic solution (TRAVATAN Z®) in subjects with normal tension glaucoma.

Enrollment

32 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of normal tension glaucoma.
Must sign an Informed Consent form.
IOP within protocol-specified range.
Other protocol-specified inclusion criteria may apply.

Exclusion criteria

Pregnant and lactating women, or women who intend to become pregnant during the study period.
Advanced and serious glaucoma, as specified in protocol.
Complicated chronic or recurrent uveitis, scleritis or corneal herpes.
History of ocular trauma, intraocular surgery or laser surgery for the included eye.
Ocular-infection and severe ocular complication.
Best-corrected visual acuity (BCVA) worse than 0.2 decimal.
Difficulty in conducting applanation tonometry for the included eye as determined by the doctor.
Severe or serious hypersensitivity to prostaglandin analogues or any ingredients used in the study.
Use of IOP lowering ophthalmic solutions other than TRAVATAN Z® or oral carbonic anhydrase inhibitor (Diamox, etc.) during the study period.
Use of any adrenocorticosteroids during the study period.
Use of IOP lowering ophthalmic solution within the past 30 days.
Regarded by doctor as not suitable for study participation.
Other protocol-specified exclusion criteria may apply.