A Prospective, Non-interventional, Longitudinal Cohort Study To Evaluate The Long-term Safety Of Latanoprost Treatment In Pediatric Populations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 175
- 试验地点
- 29
- 主要终点
- Change From Baseline to Last Available Observation in Best Corrected Visual Acuity (BCVA) (Snellen or Equivalent)
研究概览
简要总结
This is a non-interventional, prospective, longitudinal cohort study. A total of 150 pediatric subjects with glaucoma or elevated intraocular pressure, including 75 latanoprost-treated subjects and 75 non-topical prostaglandin analogue treated subjects, will be enrolled from ophthalmic hospital clinics and academic ophthalmic centers. As a non-interventional study, the study subjects' continued use of latanoprost and assessments of ocular events will be obtained through the routine medical follow-up with treating ophthalmologists or other designated members of the medical care team.
详细描述
At least 40 subjects in each of the following age groups: 1-<5 years and 5-<18 years. No minimum required numbers in the <1 year age group.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female <18 years of age (neonates must be at least 36 weeks gestational age).
- •Diagnosis of pediatric glaucoma or elevated intraocular pressure.
- •Evidence of a personally signed and dated informed consent document indicating that the subject (and/or a legally acceptable representative) has been informed of all pertinent aspects of the study. A signed and dated assent will be required where applicable according to local laws.
- •For treated subjects only:
- •Continuously treated with latanoprost for at least 1 month within the year prior to the baseline examination.
- •For untreated subjects only:
- •Continuously treated with latanoprost or other topical prostaglandin analogues for less than one month prior to the baseline examination (based on the best knowledge of treating ophthalmologists), and unlikely to be treated with latanoprost or other topical prostaglandin analogues during the three-year study period; OR
- •No prior treatment with latanoprost or other topical prostaglandin analogues, and unlikely to be treated with latanoprost or other topical prostaglandin analogues during the three-year study period.
排除标准
- •Unable/unwilling to comply with protocol.
- •Pregnant or nursing females at baseline.
- •For treated subjects only: a history of allergy or hypersensitivity to any of the ingredients contained in latanoprost (e.g., hypersensitivity to benzalkonium chloride).
结局指标
主要结局
Change From Baseline to Last Available Observation in Best Corrected Visual Acuity (BCVA) (Snellen or Equivalent)
时间窗: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Patients familiar with the letters of the alphabet were evaluated using Snellen visual acuity. Patients who were unable or unfamiliar with the letters of the alphabet were evaluated using charts made up of numbers, pictures (eg, Schering's Children's Eye Chart or Allen Cards), E's, or Landolt's broken rings, and other methods which were equivalent to Snellen acuity eg, HOTV testing).
次要结局
- Iris Color Darkening(Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months)
- Change From Baseline to Last Available Observation in Horizontal Corneal Diameter (by Caliper and/or Ruler)(Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months)
- Change From Baseline to Last Available Observation in Intraocular Pressure (IOP)(Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months)
- Change From Baseline to Last Available Observation in Length of Eyelash (by Caliper and/or Ruler)(Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months)
- Cup-to-disc Ratio (for Assessment of Optic Nerve Changes/Structures) - Number of Participants With Clinically Significant Deterioration in Cup/Disc Ratios(Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months)
- Eyelash Darkening/Thickening(Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months)
- Localized Pigmentation (Nevi or Freckles) of Conjunctiva, Iris and Choroid(Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months)
- Number of Participants With Clinically Meaningful Change in Refractive Error(Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months)
- Visual Field Defects - Number of Participants With Clinically Significant Deterioration of Visual Field Defects.(Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months)
- Change From Baseline to Last Available Observation in Corneal Thickness (Pachymeter)(Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months)
- Conjunctival/Ocular Hyperemia(Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months)
- Number of Participants With a Change in Anterior Segment Biomicroscopy(Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months)
- Number of Participants With Abnormalities in Fundoscopy Posterior Segment at Baseline(Evaluated at Baseline)