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®)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 84
- 主要终点
- Overall Mean Intraocular Pressure (IOP)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Travoprost 0.004% ophthalmic solution (Drug)
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
干预措施: Bimatoprost 0.01% ophthalmic solution (Drug)
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
干预措施: Travoprost 0.004% ophthalmic solution (Drug)
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
干预措施: Bimatoprost 0.01% ophthalmic solution (Drug)
结局指标
主要结局
Overall Mean Intraocular Pressure (IOP)
时间窗: Week 6
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.
次要结局
- Mean IOP at Each After Office Hour Evaluation Timepoint(Week 6: 4 pm, 6 pm, 8 pm)