An Open Label, Randomized, Multicenter, Prospective, Comparative Clinical Study to evaluate Efficacy and Safety of Isotine Plus I Eye Drop and Capsule Iso fala in participants with Myopia and Presbyopia.
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Cohort 1:
研究概览
简要总结
It is an open label, randomized, multi-center, prospective, comparative clinical study to evaluate efficacy and safety of Isotine Plus I Eye Drop and Capsule Iso fala in participants with Myopia and Presbyopia. The study will be carried out at 4 to 5 centres in India. There will be two cohorts as Cohort 1 (Participants with myopia) and Cohort 2 (Participants with presbyopia). As per computer generated randomization list, subjects will be randomized either to ISOTINE PLUS I EYE DROP and Capsule Iso fala group or Standard treatment group in 1: 1 ratio. Subjects in ISOTINE PLUS I EYE DROP and Capsule Iso fala group, will be asked to use ISOTINE PLUS I EYE DROP in a dose of 1 drop in each eye 4-5 times daily and 1 Capsule Iso fala twice daily orally after meals with water for 6 months. Subjects in the standard treatment group will be given moisturizing eye drops for a period of 6 months.
Cohort 1: The primary objective of the cohort 1 will be to assess comparative difference in Autorefraction (Spherical equivalent). Secondary objectives of the cohort 1 will be to assess comparative change in clinical symptoms, comparative change in axial length, comparative difference in corneal curvature, comparative difference in visual acuity, comparative assessment of vision targeted health status, global assessment of overall change by investigator and subject, global assessment of tolerability of study products by investigator and subject and adverse events. Cohort 2: The primary objective of the cohort 2 will be to assess Number of Subjects With greater than or equal to 3 Lines Gain in Near Best Distance Corrected Visual Acuity (BDCVA) (at 40 cm). Secondary objectives of the cohort 2 will be to assess comparative change in clinical symptoms, quality of Life, comparative assessment of vision targeted health status, global assessment of overall change by investigator and subject, global assessment of tolerability of study products by investigator and subject and of adverse events on baseline visit (Day 0) and every month assessment till 6 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 16.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •Cohort 1:
- •Equal number of participants will be recruited in the age group of 8 to 16 years and 16 to 30 years
- •Spherical equivalent refraction (SER): -1.00 to -5.00D
- •Parents willing to sign informed consent and allow their children to undergo all the study procedure.
- •Cohort 2:
- •Literate Male or Female between 40 and 55 years of age.
- •Distance-corrected near visual acuity (DCNVA) for each eye, as well as for binocular vision, equivalent to 0.3 logMAR or worse; or 20 by 40 Snellen or worse at 40 cm
- •Subjects willing to sign informed consent and to undergo all the study procedure.
排除标准
- •Cohort 1:
- •Use of any topical prescription or OTC ophthalmic medications of any kind within 7 days of Screening until study completion.
- •Use of any over-the-counter (OTC) artificial tears (preserved or unpreserved) at least once per day within 7 days of Screening.
- •History of any disease or syndrome predisposing the subject to severe myopia (Marfan syndrome, Stickler syndrome, retinopathy of prematurity, etc.).
- •that might interfere with the study as deemed by the Investigator
- •History or current history of glaucoma or ocular hypertension.
- •History of any refractive ocular anatomical anomaly (keratoconus, lenticonus, spherophakia, aphakia, etc.).
- •History of ocular diseases, excluding myopia (corneal alterations/opacities, cataract, retinal alterations, inflammatory diseases, etc.).
- •History of any type of ocular surgery.
- •Having participated in clinical research studies 30 days prior to inclusion in the present study.
- •Present active inflammatory or infectious ocular disease at the time of study entry.
- •Having undergone surgical procedures, not ophthalmologic, within the last 3 months.
- •Chronic use of any topical or systemic antimuscarinic/anticholinergic medication (atropine, scopolamine, tropicamide) within 21 days prior to screening, and/or anticipated need for its chronic use during the study period (more than 7 consecutive days in a month or more than 30 days total in a year).
- •Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
- •Known allergy, hypersensitivity, or contraindication to any component of the study medications.
- •Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the study Cohort 2:
- •Clinically significant ocular disease that might interfere with the study as deemed by the Investigator.
- •Recent or current evidence of ocular infection or inflammation in either eye.
- •Any history of herpes simplex or herpes zoster keratitis.
- •History of diabetic retinopathy or diabetic macular edema.
- •History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal.
- •Ocular trauma, ocular surgery, ocular laser treatment within the 6 months prior to screening.
- •Any subject with multifocal intraocular lenses will be excluded.
- •History of any traumatic (surgical or nonsurgical) or non-traumatic condition affecting the pupil or iris.
结局指标
主要结局
Cohort 1:
时间窗: Baseline visit (Day 0), Every month assessment till 6 months
Comparative difference in Autorefraction (Spherical equivalent)
时间窗: Baseline visit (Day 0), Every month assessment till 6 months
Cohort 2:
时间窗: Baseline visit (Day 0), Every month assessment till 6 months
Number of Subjects With greater than or equal to 3 Lines Gain in Near Best Distance Corrected Visual Acuity (BDCVA) (at 40 cm)
时间窗: Baseline visit (Day 0), Every month assessment till 6 months
次要结局
- Cohort 1:(1. Comparative change in clinical symptoms)
研究者
Dr Pushpalata D Ingale
Ayurved Seva Sanghs, Ayurved Mahavidyalaya, Nashik