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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


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


Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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