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)0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1) 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
- •1) 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.
研究者
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