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®)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01464424
First received: November 1, 2011
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Glaucoma
Ocular Hypertension
Open-Angle Glaucoma
Drug: Travoprost 0.004% ophthalmic solution
Drug: Bimatoprost 0.01% ophthalmic solution
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official 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®)

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Overall Mean Intraocular Pressure (IOP) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Mean IOP at Each After Office Hour Evaluation Timepoint [ Time Frame: Week 6: 4 pm, 6 pm, 8 pm ] [ Designated as safety issue: No ]
    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.


Enrollment: 84
Study Start Date: October 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
TRAVATAN, then LUMIGAN
Travoprost 0.004% ophthalmic solution (TRAVATAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by bimatoprost 0.01% ophthalmic solution (LUMIGAN), same dose, same duration, as randomized, for a total duration of 12 weeks
Drug: Travoprost 0.004% ophthalmic solution
Other Name: TRAVATAN® Z
Drug: Bimatoprost 0.01% ophthalmic solution
Other Name: LUMIGAN®
LUMIGAN, then TRAVATAN
Bimatoprost 0.01% ophthalmic solution (LUMIGAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by travoprost 0.004% ophthalmic solution (TRAVATAN), same dose, same duration, as randomized, for a total duration of 12 weeks
Drug: Travoprost 0.004% ophthalmic solution
Other Name: TRAVATAN® Z
Drug: Bimatoprost 0.01% ophthalmic solution
Other Name: LUMIGAN®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464424

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Doug Hubatsch, MS Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01464424     History of Changes
Other Study ID Numbers: RDG-10-003
Study First Received: November 1, 2011
Results First Received: June 26, 2013
Last Updated: September 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Glaucoma
Ocular Hypertension
Open-Angle Glaucoma
Intraocular Pressure

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Travoprost
Bimatoprost
Cloprostenol
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014