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Completed

NCT Number: NCT01464424

Assessment of Intraocular Pressure (IOP) Control in Subjects With Open-Angle Glaucoma or Ocular Hypertension Treated With Travoprost 0.004% (TRAVATAN® Z) or Bimatoprost 0.01% (LUMIGAN®)

The purpose of this study was to assess efficacy and tolerability of travoprost 0.004% vs. bimatoprost 0.01% during the after office hour period (4 pm to 8 pm) in subjects with open-angle glaucoma or ocular hypertension after 6 weeks of treatment.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT) in at least one eye.
  • Non-study eye: Intraocular pressure (IOP) able to be controlled with no pharmacologic therapy or on the study medicine alone.
  • Willing to discontinue the use of all other ocular hypotensive medications prior to receiving study medication and for the entire course of the study.
  • Able to follow instructions, self instill study article, and attend all study visits.
  • Best-corrected Snellen visual acuity of 20/200 or better in each eye.
  • Sign Ethics Committee reviewed and approved informed consent form.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Known medical history of allergy, hypersensitivity or poor tolerance to any component of the preparations used in this study.
  • Any abnormality preventing applanation tonometry in either eye.
  • Dry eye previously or currently being treated with punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids.
  • Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
  • Intraocular conventional or laser surgery >3 months prior to consent.
  • Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
  • Progressive retinal or optic nerve disease from any cause.
  • Use of any systemic medications known to affect IOP which have not been on a stable course for at least 7 days prior to Screening or an anticipated change in dosage during the course of the study.
  • Any clinically significant, serious, or severe medical condition.
  • Women of childbearing potential who are pregnant, lactating, or not using reliable means of birth control.
  • Participation in any other study within 30 days prior to Screening.
  • Use of any systemic (oral), injectable or topical steroids.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Travoprost 0.004% ophthalmic solution

Drug

Other names: TRAVATAN® Z

Bimatoprost 0.01% ophthalmic solution

Drug

Other names: LUMIGAN®

Primary outcomes

  1. Overall Mean Intraocular Pressure (IOP)

    Time frame: Week 6

    IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm) for an overall mean. The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye. Per-protocol dataset was pre-specified for this non-inferiority analysis.

Secondary outcomes

  1. Mean IOP at Each After Office Hour Evaluation Timepoint

    Time frame: Week 6: 4 pm, 6 pm, 8 pm

    IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm). The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Assessment of Late Day IOP Control in Subjects With Open-Angle Glaucoma or Ocular Hypertension Treated With Travoprost 0.004% (TRAVATAN® Z) or Bimatoprost 0.01% (LUMIGAN®)

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 3, 2011
Registry last updated
Sep 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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