Assessment of the Efficacy of Ocular Dipyridamole in the Treatment of Dry Eye Symptomology in Subjects With Pterygium
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 主要终点
- Assess the changes in dry eye parameters via reduction in dry eye symptomology.
研究概览
简要总结
Subjects with pterygium and associated dry eye symptoms (DES) are randomized into an active cohort (receiving ocular administration of Dipyridamole) or placebo cohort (ocular administration of vehicle). Monthly follow up is conducted for 12 months. Testing conducted at follow up will assess dry eye / pterygium symptoms and endpoints and review the efficacy of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide informed consent.
- •Ineligible or refused surgical excision, or had recurrence of pterygium following surgical excision
- •Able to follow the study instructions, including application of the study product
- •Agreement not to change the type of lubricating eye drops used (if any) during their participation in the study.
- •Assessed as having at least pterygium stage 0-1 (pinguecula) based on Johnston, Williams & Sheppard's classification for pterygium
- •Concomitant dry eye symptoms, as determined by one or more of the following Subject interview (modified Ocular Surface Disease Index test), Tearing, Itch / foreign body sensation, Positive Fluorescein test, Positive TBUT test, Positive Tear meniscus test
排除标准
- •Inability to provide informed consent
- •Dry eye due to other factors
- •Known lacrimal obstruction
- •Contact lens wearers
- •Non-corrected refraction
- •Allergy or sensitivity to dipyridamole or excipients
- •Use of dipyridamole in the last 6 months
- •Other eye conditions (i.e. active ocular infection, herpes keratitis in last 6 months, corneal disorder abnormality excluding pterygium, history of ocular acne rosacea, blepharitis) which would impact results
- •Diagnosis of ALS (Amyotrophic lateral sclerosis)
- •Existing conditions which are contraindicated or precaution in use of dipyridamole or excipients
- •Use of eye drops (other than ocular lubricants)
- •Pregnant or breastfeeding
- •Inability to apply the medical product or follow the study procedures
- •Anything that the PI thinks would impact the trial
研究组 & 干预措施
Active
Dipyridamole eye drops 8.48 mg in 100ml
1 drop three times a day for 1 year
干预措施: Dipyridamole (Drug)
Placebo
Fluorescein in Active Vehicle
1 drop three times a day for 1 year
干预措施: Placebo (Drug)
结局指标
主要结局
Assess the changes in dry eye parameters via reduction in dry eye symptomology.
时间窗: 6 months
Reduction in dry eye symptomology will be defined as ONE of the following relative to baseline, determined by subject feedback * An improvement in questionnaire scores * Specified improvement in blurred vision grading * Specified improvement in tearing grading * Specified improvement in itch / foreign body (grittiness) sensation grading.
Assess the changes in dry eye parameters via a change in tear secretion rate
时间窗: 6 months
Change in the tear secretion rate will be defined by successful change in parameters of ONE of the following testing methods compared to baseline: 1. Fluorescein - Improvement of one of the quadrants sufficient to change the severity rating 2. TBUT (Tear Breakup time) - Decreased by at least 1 second 3. Tear meniscus test - Increase of at least 0.2mm
次要结局
- A minimum significant reversion of pterygia relative to baseline or cessation of growth of pterygium(12 months)