Investigation of IOP reduction efficacy of Travoprost Ophthalmic Solution in patients with normal tension glaucoma

Not Applicable

• Conditions: normal tension glaucoma

• Registration Number: JPRN-UMIN000011621
• Lead Sponsor: Alcon Japan Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-02
• Study Completion: 2014-08-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

1.Pregnant women, lactating women or women who wish pregnancy during the study period. 2.A subject with Angle Grade in Shaffer classification 2 or less 3.Subjects whose glaucoma may be advanced and serious (less than -12 dB in MD). 4.Subjects who have complicated chronic or recurrent uveitis, scleritis or corneal herpes. 5.Subjects who have a history of ocular trauma, intraocular surgery or laser surgery for the included eye. 6.Subjects with ocular-infection and severe ocular complication. 7.Subjects whose BCVA is worse than 0.2. 8.Subjects who are difficult to conduct applanation tonometry for the included eye. 9.Subjects with known hypersensitivity to prostaglandin analogues or any ingredients used in the study. 10.Subjects who must use IOP lowering ophthalmic solutions other than Travatanz or oral carbonic anhydrase inhibitor (Diamox etc.) during the study period. 11.Subject who need any adrenocorticosteroids during the study period. 12.Subjects who received IOP lowering ophthalmic solution within the past 30 days. 13.Subjects whose doctors judged they are not suitable for the study participation.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy Main Outcome Measures IOP change values from baseline pooled at 9 o'clock at 4, 8 and 12 weeks.

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome Measures IOP change values and change rates from baseline at 9 o'clock at 4, 8 and 12 weeks, and at 13 o'clock and 17 o'clock at 12 weeks. Safety Slit-lamp biomicroscopy, conjunctival hyperemia, SPK, periocular changes, adverse event