A Phase III Study of Travoprost/Timolol Combination in Patients With Open-Angle Glaucoma or Ocular Hypertension
Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Open-Angle Glaucoma; Ocular Hypertension
Intervention: Travoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution (Drug); Travoprost 0.004%/Timolol 0.5% ophthalmic solution (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Alcon Research Official(s) and/or principal investigator(s):
Pamela Smith, B.S., Study Director, Affiliation: Alcon Research
Summary
The purpose of this study is to demonstrate equivalent safety and IOP-lowering effectiveness
of two Travoprost/Timolol combination products in patients diagnosed with open-angle
glaucoma or ocular hypertension. This global study will be conducted in the US (C-07-64,
NCT00672997) and Japan (C-08-08, NCT00760539).
Clinical Details
Official title: A Six-Week, Multi-Center, Double-Masked, Safety and Efficacy Study of Travoprost 0.004%/Timolol 0.5% BAC-free Compared to Travoprost 0.004%/Timolol 0.5% in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Mean Intraocular Pressure (IOP) combined across all visits and timepoints
Secondary outcome: Percentage of patients with IOP <18 mmHg or IOP percent reduction of ≥ 30% by visit
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Open-angle glaucoma or confirmed ocular hypertension.
- Mean IOP in at least one eye, the same eye(s):22-36 mmHg at 9 AM on eligibility
visits 1 & 2 and 21-36 mmHg at 11 AM and 4 PM on Eligibility Visits 1 & 2.
- Sign an informed consent form.
- Discontinued use of all IOP-lowering medications(s) for a minimum of 4 days to a
minimum of 27 days or more prior to the Eligibility 1 Visit.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Females of childbearing potential who are pregnant, planning to become pregnant
during the study period, breast-feeding, or not using adequate birth control
measures.
- Any form of glaucoma other than open-angle glaucoma (with or without a pigment
dispersion or pseudoexfoliation component) or confirmed ocular hypertension.
- History or current evidence of chronic or recurrent severe inflammatory eye disease
in either eye.
- History or current evidence of clinically relevant or progressive retinal disease
such as retinal degeneration, diabetic retinopathy, or retinal detachment in either
eye.
- Best-corrected visual acuity (BCVA) worse than 0. 6 logMAR in either eye.
- Severe central visual field loss in either eye.
- Not able to safely discontinue use of all IOP-lowering ocular medication(s) according
to the Ocular Hypotensive Medication Washout Schedule.
- History or current evidence of bronchial asthma, or severe chronic obstructive
pulmonary disease (COPD) that would in the opinion of the investigator preclude the
safe administration of a topical beta-blocker.
- History or other evidence of severe illness or any other conditions which would make
the subject, in the opinion of the investigator, unsuitable for the study.
- Other protocol-defined exclusion criteria may apply.
Locations and Contacts
Additional Information
Starting date: May 2008
Last updated: July 14, 2014
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