Ocular Hypertension Clinical Trial
Official title:
Investigation of the Effect of Travoprost Ophthalmic Solution of Lowering Intraocular Pressure in Patients With Normal Tension Glaucoma
Verified date | October 2015 |
Source | Alcon Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | Alcon Japan, Ltd. | Tokyo |
Lead Sponsor | Collaborator |
---|---|
Alcon Research |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Change From Baseline in IOP (9:00 AM) at Week 4, Week 8, and Week 12 | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data at 9:00 AM from Weeks 4, 8, and 12 were pooled. A more negative change indicates a greater amount of improvement. One eye (study eye) was subject to analysis. | Baseline (Day 0), Week 4, Week 8, Week 12 | No |
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