CTRI/2018/08/015480进行中（未招募）未知
A prospective randomized, double blind, placebo controlled pilot study to evaluate the safety and efficacy of topical dipyridamole in the treatment of symptomatic ocular surface conjunctival degenerative lesions i.e. pinguecula and pterygium.
OD Ocular Discovery Ltd0 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
- 未知
- 状态
- 进行中（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.Healthy Male & Female Volunteers, age >=18 years, diagnosed with symptomatic ocular conjunctival degenerative lesions (pterygium or pinguecula)2.Subjects with lesion redness >=1, (scale 0 to 4)3.Women of child bearing potential must use methods of contraception, deemed effective by the Investigator, during study-related treatment 4.Subjects able to understand and willing to provide written informed consent 5.Subjects able to read and understand the requirements of the study and willing and able to participate and comply with all trial requirements 6.Subjects who have not participated in any clinical trial of a drug by ocular or systemic administration within the previous four weeks 7.Subject must be available for and willing to attend all evaluation visits
排除标准
- •1. Presence of uncontrolled systemic disease 2. History of ophthalmic topical or systemic cyclosporine or steroids in the past 30 days 3. History of systemic or topical drugs that are known to cause dry eye in the last 30 days 4. History of artificial tears / lubricating drops use >=4 times daily 5. Use of non-trial eye drops during the trial 6. History of contact lens use in the last 30 days 7. History of allergic reaction or sensitivity to study drugs and excipients in the formulation 8. History of dipyridamole use in the previous 2 months 9. Evidence of active ocular infection, herpes keratitis (in last 2 months), or current active external eye pathology other than pinguecula and/or pterygium that might affect the results of the study. (E.g. KCS secondary to the destruction of conjunctival goblet cells occurring with vitamin A deficiency; scarring; cicatricial pemphigoid; alkali burns; Stevens-Johnson syndrome; trachoma; or irradiation eyelid exposure). 10. Presence of corneal haziness other than haziness caused by current pterygium or from presence of stable scars 11. Any ocular surgery within previous 2 years 12. Presence of uncontrolled blood glucose levels at time of screening ( >11.1mmol/l or 200mg/dl 2 hours after eating, or >7mmol/l or 126mg/dl in fasted state) 13. IOP >25 mmHg 14A female subject who is breast-feeding, pregnant, or intends to become pregnant during the study period 15Women that have a positive test result for pregnancy at the time of enrollment 16Participation in a clinical trial within 30 days prior to screening.
研究者
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