Phase 4
N=32
Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma
Normal Tension Glaucoma · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01995136 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcome: Primary: Mean Change From Baseline in IOP (9:00 AM) at Week 4, Week 8, and Week 12 — 16.55; -3.37 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Travoprost Ophthalmic Solution 0.004% (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Jun 2014
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 | — |
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.
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.
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.