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®)
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®)
1 other identifier
interventional
84
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2011
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 1, 2011
CompletedFirst Posted
Study publicly available on registry
November 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
September 4, 2013
CompletedSeptember 13, 2013
September 1, 2013
8 months
November 1, 2011
June 26, 2013
September 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Mean Intraocular Pressure (IOP)
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.
Week 6
Secondary Outcomes (1)
Mean IOP at Each After Office Hour Evaluation Timepoint
Week 6: 4 pm, 6 pm, 8 pm
Study Arms (2)
TRAVATAN, then LUMIGAN
OTHERTravoprost 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
LUMIGAN, then TRAVATAN
OTHERBimatoprost 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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Related Publications (1)
DuBiner HB, Hubatsch DA. Late-day intraocular pressure-lowering efficacy and tolerability of travoprost 0.004% versus bimatoprost 0.01% in patients with open-angle glaucoma or ocular hypertension: a randomized trial. BMC Ophthalmol. 2014 Nov 28;14:151. doi: 10.1186/1471-2415-14-151.
PMID: 25432143DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Doug Hubatsch, Global Brand Leader, Medical Affairs
- Organization
- Alcon Research, Ltd.
Study Officials
- STUDY DIRECTOR
Doug Hubatsch, MS
Alcon Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2011
First Posted
November 3, 2011
Study Start
October 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
September 13, 2013
Results First Posted
September 4, 2013
Record last verified: 2013-09