Back to resultsAssessment 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®)
Primary Purpose
Glaucoma, Ocular Hypertension, Open-Angle Glaucoma
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Travoprost 0.004% ophthalmic solution
Bimatoprost 0.01% ophthalmic solution
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, Ocular Hypertension, Open-Angle Glaucoma, Intraocular Pressure
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
TRAVATAN, then LUMIGAN
LUMIGAN, then TRAVATAN
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Mean IOP at Each After Office Hour Evaluation Timepoint
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01464424
Brief Title
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®)
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®)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension, Open-Angle Glaucoma
Keywords
Glaucoma, Ocular Hypertension, Open-Angle Glaucoma, Intraocular Pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TRAVATAN, then LUMIGAN
Arm Type
Other
Arm Description
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
Arm Title
LUMIGAN, then TRAVATAN
Arm Type
Other
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Travoprost 0.004% ophthalmic solution
Other Intervention Name(s)
TRAVATAN® Z
Intervention Type
Drug
Intervention Name(s)
Bimatoprost 0.01% ophthalmic solution
Other Intervention Name(s)
LUMIGAN®
Primary Outcome Measure Information:
Title
Overall Mean Intraocular Pressure (IOP)
Description
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.
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Mean IOP at Each After Office Hour Evaluation Timepoint
Description
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.
Time Frame
Week 6: 4 pm, 6 pm, 8 pm
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doug Hubatsch, MS
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
25432143
Citation
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.
Results Reference
derived
Learn more about this trial
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®)
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