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CompletedNCT00872651Updated Mar 28, 2013

Travoprost 0.004%/Timolol 0.5% Versus Latanoprost 0.005%/Timolol in Chinese Patients With Open-Angle Glaucoma or Ocular Hypertension

A Phase 3 interventional study of Travoprost 0.004%/Timolol 0.5% and Latanoprost 0.005% / Timolol 0.5% in Open-angle Glaucoma and Ocular Hypertension, sponsored by Alcon Research. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-28.

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

Phase
Phase 3
Study type
Interventional
Enrollment
242
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Eligible patients will be randomized in a 1.1 ratio to receive Travoprost 0.004%/timolol 0.5% once daily or Latanoprost 0.005%/Timolol 0.5% once a day for 8 Weeks. The study treatments will be compared for mean diurnal intraocular pressure (IOP) change from baseline at Week 8.

Safety parameters measured at 4 study visits: ocular signs, visual acuity, dilated fundus, cardiovascular parameters (blood pressure and pulse), and adverse events.

02

Conditions studied

  • Open-angle Glaucoma
  • Ocular Hypertension

Keywords

  • Glaucoma
  • intraocular pressure
  • travoprost/timolol
  • timolol
03

In context

Glaucoma

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

This study's enrollment of 242 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.

04

Who can participate

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

Inclusion criteria

  • Patients of either sex and any race, 18 years of age or older, diagnosed with open angle glaucoma or ocular hypertension who are not sufficiently responsive to topical beta-blockers or prostaglandin analogues.
  • Patients must meet the following IOP criteria in at least one eye. For each qualifying eye, the mean IOP should be ≥21 mmHg at 9 AM and 11 AM time points at the eligibility visit
  • The mean IOP in either eye at the eligibility visit must not be greater than 35 mmHg at any time point.

Exclusion criteria

Exclusion Criteria:

  • Patients with any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component) or ocular hypertension.
  • Patients with iridocorneal angle Shaffer grade \< 2 (extreme narrow angle with complete or partial closure) angle in either eye, as measured by gonioscopy
  • Patients with a cup/disc ratio greater than 0.80 (horizontal or vertical measurement) in either eye.
  • Patients with severe central visual field loss in either eye. Severe central field loss is defined as a sensitivity of ≤ 10 dB in at least 2 of the 4 visual field test points closest to the point of fixation.
  • Current chronic, recurrent or severe inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis), or current other severe ocular pathology (including severe dry eye) that would affect the conduct of the study.
  • History of ocular trauma within the past 6 months.
  • Intraocular surgery within the past 3 months.
  • Ocular laser surgery within the past 3 months.
  • Best-corrected visual acuity score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal)
  • Current ocular infection or inflammation, or history of ocular infection or inflammation within the past 3 months, as determined by patients' history and/or examination.
  • History of or current clinically relevant or progressive retinal disease, such as retinal degeneration, diabetic retinopathy or retinal detachment.
  • Any abnormality preventing reliable applanation tonometry.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
242 participants (actual)

Study arms

  • Experimental
    Travoprost 0.004%/Timolol 0.5%

    Travoprost 0.004%/Timolol 0.5%

    Drug: Travoprost 0.004%/Timolol 0.5%

  • Active comparator
    Latanoprost 0.005% / Timolol 0.5%

    Latanoprost 0.005% / Timolol 0.5%

    Drug: Latanoprost 0.005% / Timolol 0.5%

Interventions

  • DrugTravoprost 0.004%/Timolol 0.5%

    Travoprost 0.004%/Timolol 0.5%

  • DrugLatanoprost 0.005% / Timolol 0.5%

    Latanoprost 0.005% / Timolol 0.5%

06

What researchers measure

Primary outcomes

  1. Intraocular pressure (IOP)

    Mean Diurnal Intraocular Pressure (IOP) (averaged at 9 AM, 11 AM and 4 PM) change from baseline at Week 8.

    Time frame: 8 weeks

Secondary outcomes

  1. Intraocular Pressure (IOP)

    Mean IOP change from baseline at 9 AM at Week 2 and Week 6 visits and at 9 AM, 11 AM and 4 PM at Week 8 visit.

    Time frame: 8 weeks

07

Study locations

1 site
  • Zhongshan Ophthalmic Center, Sun Yat-sen University
    Guangzhou, Guangdong 510060, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00872651
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Mar 31, 2009
Start date
Jan 2010
Primary completion
Nov 2011
Completion
Nov 2011
Last update
Mar 28, 2013

Oversight

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

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This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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