CTRI/2023/01/049169尚未招募4 期
A Multi-Center, Single Arm, Phase IV Study to Assess the Safety and Efficacy of Atropine Ophthalmic Solution to Control the Progression of Myopia in Children of 5 Years and Above
Sun Pharma Laboratory Limited ( SPLL)18 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年1月27日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 18
- 主要终点
- Safety:
研究概览
简要总结
| This is a Phase IV, multicenter, single arm study. The study will be conducted at approximately 10-12 number of centers in India, having qualified Investigators. The study will be initiated only after the receipt of regulatory and ethics committee (EC) approval. |
| Screening period |
| After obtaining the written informed consent, patients will be screened by undergoing various assessments as mentioned in Schedule of Assessment (Appendix I). After confirming the eligibility on Day 1, patients will be enrolled by allotting the enrolment number. Patients will be taking Atropine 0.01% ophthalmic solution for 12 months (Treatment period). During the study, assessments will be performed as mentioned in Schedule of Assessment (Appendix I). |
Treatment Period
Each patient will receive post-enrolment diary to record the use of study medication and details pertaining to any events. Patients will use glasses, if needed. Investigator will offer photochromatic glasses (which darken on exposure to ultraviolet or sunlight) if patients experience glare or their parents are worried of excessive light exposure, or progressive glasses (reading add) if patients experience difficulty with near vision.
The study has following visits:
Visit 1: Screening (Day -7 to -1)
Visit 2: Enrolment Visit (Day 1)
| Visit 3: Day 14 ± 2 (Week 2) |
Visit 4: Month 4 ± 4 days
Visit 5: Month 8 ± 4 days
Visit 6: Month 12 ± 4 days Early Termination/ End of Treatment & End of Study visit
Patients will receive diary to record details about study drug instillation and adverse events.
Patients early terminating from the study will be completing Visit 06 assessments. Visit 06 will be considered as end of treatment and end of study day. The safety and efficacy will be assessed during the study period. For safety endpoint, Day 1 will be considered as a baseline and for efficacy endpoints, Day 14 will be considered as a baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 5.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either gender, aged 5 to 14 years (both inclusive) and ready to give written informed assent to participate in the study and written informed consent from parents of participating child 2) Patients with documented active myopia progression of at least spherical equivalent -0.50 D over the last 12 months as determined or suggested by refractive records or change in lens power 3) Patients with refractive error of spherical equivalent -2.00 D or worse in each eye as measured by cycloplegic autorefraction 4) Patients with a difference between non-cycloplegic subjective spherical refraction and cycloplegic subjective spherical refraction of not greater than -1.00 D 5) Patients with astigmatism of ≤ -1.50 D as measured by cycloplegic or non-cycloplegic autorefraction 6) Patients with distance vision correctable to logarithm of the minimum angle of resolution (logMAR) 0.2 or better in both eyes using Early Treatment Diabetic Retinopathy study chart (ETDRS) method 7) Patients with normal intraocular pressure of ≤ 21 mmHg 8) Patients with normal ocular health other than myopia in less than 06 months of screening 9) Patients willing and able to tolerate cycloplegia and mydriasis 10) Patients willing to come for regular follow-up for 12 months and follow study procedure 11) Female patients of age ≥ 12 years must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till the last dose of the study medication (such contraception may include hormonal birth control e.g., combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or total sexual abstinence).
排除标准
- •Patients with ocular or systemic diseases which may affect vision or refractive error 2) Patients with any ocular condition wherein topical atropine is contraindicated (e.g. glaucoma or narrow angle glaucoma) 3) Patients with previous or current use of atropine 4) Patients with abnormal binocular function and stereopsis 5) Patients with amblyopia or manifest strabismus, including intermittent tropia 6) Patients with history or planning to undergo any ocular surgery 7) Patients who are on treatment of monoamine oxidase inhibitors (MAOI) or planning to take during study period 8) Patients who are hypersensitive to atropine, cyclopentolate, or any other cycloplegic agents including its components 9) Patients with any other conditions precluding adherence to the protocol including unwillingness to refrain from contact lens wear for the duration of the study 10) Participation in any investigational study within 30 days prior to screening 11) Pregnant or lactating female patients 12) Patients with any clinically significant lab abnormalities/ condition (e.g. cardiac or respiratory distress) which in the opinion of investigator would compromise the well-being of the patient or the conduct of the study, or prevent the patient from meeting or performing study requirements 13) Employee of the sponsor, investigator, or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees of sponsor or the investigator.
结局指标
主要结局
Safety:
时间窗: 12 Month
Proportion of participants with treatment emergent adverse events (TEAEs) (Photophobia and poor near visual acuity) in the study
时间窗: 12 Month
次要结局
- A. Efficacy(1. Spherical equivalent refraction (SER) determined by cycloplegic autorefraction from baseline)
研究者
研究点 (18)
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