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CompletedNCT00672997Updated Jul 16, 2014

A Phase III Study of Travoprost/Timolol Combination in Patients With Open-Angle Glaucoma or Ocular Hypertension

A Phase 3 interventional study of Travoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution and Travoprost 0.004%/Timolol 0.5% ophthalmic solution in Open-Angle Glaucoma and Ocular Hypertension, sponsored by Alcon Research. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2014-07-16.

Sponsored by Alcon Research · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
301
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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).

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Conditions studied

  • Open-Angle Glaucoma
  • Ocular Hypertension

Keywords

  • Glaucoma
  • Hypertension
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In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 301 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.

Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
301 participants (actual)

Study arms

  • Experimental
    Travoprost/Timolol BAC-free

    Travoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution, 1 drop in each eye, once daily (QD) at 9 AM (±30 minutes), for 6 weeks

    Drug: Travoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution

  • Active comparator
    Travoprost/Timolol

    Travoprost 0.004%/Timolol 0.5% ophthalmic solution, 1 drop in each eye, once daily (QD) at 9 AM (±30 minutes), for 6 weeks

    Drug: Travoprost 0.004%/Timolol 0.5% ophthalmic solution

Interventions

  • DrugTravoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution
  • DrugTravoprost 0.004%/Timolol 0.5% ophthalmic solution

    Also known as: DuoTrav®

06

What researchers measure

Primary outcomes

  1. Mean Intraocular Pressure (IOP) combined across all visits and timepoints

    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg).

    Time frame: Week 2 (9 AM, 11 AM, and 4 PM); Week 6 (9 AM, 11 AM, and 4 PM)

Secondary outcomes

  1. Percentage of patients with IOP <18 mmHg or IOP percent reduction of ≥ 30% by visit

    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg).

    Time frame: Week 2 (9 AM, 11 AM, and 4 PM); Week 6 (9 AM, 11 AM, and 4 PM)

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Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00672997
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
May 6, 2008
Start date
May 2008
Primary completion
Dec 2008
Completion
Dec 2008
Last update
Jul 16, 2014

Study contacts

Pamela Smith, B.S.
study director · Alcon Research

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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