normal tension glaucoma
Conditions
Interventions
None listed
Sponsors
Alcon Japan Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects who do not start new IOP lowering ophthalmic solution or are not on current medication and diagnosed as normal tension glaucoma. 2.Subjects who can understand informed consent forms approved by Ethical Review Board and provide consent. 3.Subjects aged 20 or more at the time of consent obtained. 4.Subjects whose IOPs of the included eye at 9 o'clock, 13 o'clock and 17 o'clock at baseline are more than 10 mmHg and 20 mmHg or less. 5.No criteria on sex. 6.No criteria on outpatient/inpatient.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Main Outcome Measures IOP change values from baseline pooled at 9 o'clock at 4, 8 and 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactHiroshi Yabe
Bell Medical Solutions Inc Clinical Research Group Clinical Research and Development Division
Outcome results
None listed