Evaluation of efficacy and safety of bimatoprost 0.01% (Careprost) preservative-free (PF) ophthalmic solution in comparison toconventional bimatoprost 0.01% (Lumigan) ophthalmic solution for glaucoma or ocular hypertension in Indian population
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Change in intraocular pressure (IOP) of the subject’s eye/eyes.
研究概览
简要总结
This study is designed to evaluate the safety and efficacy of a preservative- free(PF) bimatoprost 0.01% formulation that was developed as an alternative for patients with sensitivity or allergies to preservatives. This is an open label, prospective, randomized, multi-center, controlled, parallel group, non-inferiority clinical phase IV study in 200 Indian patients. The study will include at least 4 evaluation points: Enrollment Visit and patient assessments at 02 weeks, 06 weeks and 12 weeks after randomization. Eligible patients will be enrolled as per Inclusion and exclusion criteria. Subjects will be randomized as per 1:1 study treatment ratio. Statistics team will prepare a randomization and it will be provided to each investigator for enrollment. Patients will be provided/dispensed study medication kits containing unit-dose containers (each for single use) both formulations. Patients will be instructed to instill one drop in each affected eye once daily in the evening, starting on the day of the baseline visit.
Follow-up visits are scheduled at weeks 2, 6 and 12. IOP will be measured using a tonometer at 8:00, 12:00 and 16:00 (within 01 hour of scheduled time) at each visit.
Efficacy Variable will be measure as change in Intraocular Pressure (IOP) from baseline of the study eye at each time points. Safety analysis include Visual Acuity, Conjuctival Hyperemia, any AEs
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Men and women aged ≥18 years.
- •Diagnosis of ocular hypertension (OHT) or primary open angle glaucoma (POAG) in one eye or both eyes 3) Unmedicated IOP ≥ 22 -30 mmHg in one or both eyes with no more than 5 mmHg inter-eye difference 4) Willing to give informed consent.
- •Best corrected visual acuity equivalent to a Snellen score of 20/100 or better in each eye.
- •For ongoing medication below is acceptable minimum washout period.
- •04 days for parasympathomimetic and topical or systemic carbonic anhydrase inhibitors, 02 weeks for sympathomimetics and α-agonists 04 weeks for β-adrenergic blocking agents, combination products and prostaglandin agonists 7) Women of child bearing potential practicing an acceptable method of birth control as judged by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), oral or long acting injected contraceptives] from at least 2 months prior to study entry and through the duration of the study; or be postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject); or with a negative urine pregnancy test.
排除标准
- •History of allergic hypersensitivity or poor tolerance to any of the components of the preparations to be used in this study.
- •Known lack of ocular hypotensive response to topical ophthalmic, prostaglandin analogs (in the opinion of the investigator).
- •Intraocular conventional surgery or laser surgery within six months of the study.
- •Use of contact lenses during the study; 5) Use of systemic corticosteroids within 21 days before any study visit; 6) Use of ophthalmic corticosteroids within 2 months or during the study; 7) History of inadequate IOP control on bimatoprost monotherapy; 8) Any clinical ocular surface ï¬ndings at baseline such as trace or greater hyperaemia or irritation.
- •Refractive surgery in the study eye (e.g., radial keratotomy, PRK, LASIK, etc.) within the past 3 months.
- •Ocular trauma within the past 3 months.
- •Progressive retinal or optic nerve disease apart from glaucoma or a torn posterior lens or having had a risk for macular edema.
- •Concurrent infectious/non-infectious conjunctivitis, keratitis, or uveitis in either eye.
- •Other than ocular hypotensive drugs, which must be washed out according to the provided schedule, ocular medication of any kind (with the exception of lubricating drops for dry eye) within 30 days of baseline.
- •Any abnormality preventing stable applanation tonometry.
- •Clinically significant ocular disease (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca), which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive drugs, is not judged safe.
- •Clinically significant systemic disease, which might interfere with the study.
- •History of non-compliance to medical regimens or unwilling to comply with the study protocol.
- •Patients having uncontrolled hypertension.
- •Participation in another clinical study within thirty (30) days.
- •Changes in systemic medication within 30 days prior to screening that could have a substantial impact on IOP, or anticipated changes during the study.
- •Patients who are pregnant, nursing a child or who are not willing to use acceptable methods of contraception during the study.
结局指标
主要结局
Change in intraocular pressure (IOP) of the subject’s eye/eyes.
时间窗: Baseline to week 12.
次要结局
- Change in intraocular pressure (IOP) of the subject’s eye/eyes(from baseline to Week 2 and Week 6.)
- Changes in Visual acuity of eye/eyes(Baseline to week 2, week 6 and week 12)
- Changes in Conjunctival hyperemia of eye/eyes(Baseline to week 2, week 6 and week 12)
- Safety monitoring by AE assessment(Throughout the study period)