Phase 4
N=84
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
Bottom Line
View on ClinicalTrials.gov: NCT01464424 ↗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
| Outcome | Result | p-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.
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.