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Phase 4 N=84 Randomized Single-blind Treatment

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®)

Glaucoma · Ocular Hypertension · Open-Angle Glaucoma

Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Overall Mean Intraocular Pressure (IOP) — 17.45; 17.22 millimeters mercury (mmHg)

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Travoprost 0.004% ophthalmic solution (Drug); Bimatoprost 0.01% ophthalmic solution (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Alcon Research
Primary completion
Jun 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Mean Intraocular Pressure (IOP)
17.45; 17.22
SECONDARY
Mean IOP at Each After Office Hour Evaluation Timepoint
17.74; 17.08; 17.52; 17.32; 17.06; 17.26

Summary

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.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01464424). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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