Phase 4 Completed N=32 Treatment

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

Source: ClinicalTrials.gov NCT01995136 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2015

Primary outcomePrimary: Mean Change From Baseline in IOP (9:00 AM) at Week 4, Week 8, and Week 12 — 16.55; -3.37 mmHg

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline in IOP (9:00 AM) at Week 4, Week 8, and Week 12	16.55; -3.37	—

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01995136). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.