CTRI/2021/11/037760已完成3 期
A prospective open label two arm randomized interventional clinical study to evaluate the efficacy and safety of Maquiday (MAQUIBRIGHT®) for the treatment of dry eyes and fatigue.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Comparison of length of wetting of the Schrimer’s test strips after five minutes, providing mean value for left/right eye from Baseline to EOT
研究概览
简要总结
Maqui berry (Aristotelia chilensis)growing in the Patagonia region of Chile is rich in anthocyanins, and has beenused as a traditional medicine to treat inflammation since ancient times. Major anthocyanins contained in maqui berryare delphinidin de-rivatives with potent antioxidant activities. In particular,delphinidin-3,5-O-diglucoside is a speciï¬c compound in maqui berries,MaquiBright® also known under the trade name BrightSight® is a maqui berryextract standardized to bear not less than 35% of total anthocyanins and atleast 25% of delphinidins.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects suffering from dry eyes Dry eye severity ranging from mild to sever grade 1 to 3 using the DEWS classification Playing video games use of PCs and or a mobile phone work at VDT for more than or equal to 4 hours per day Contact lens wearer who can discontinue lenses 24 hours prior to evaluation Subjects with normal lid position and closure Subjects willing to stop previous medication for dry eyes during study period Subjects willing to avoid use of natural eye lubricants on a daily basis but not morethan 6 times a day which has to be documented Subjects have to avoid the use of natural tears lubricant on the day of Schirmers test Subjects who have not participated in a similar investigation in the past four weeks Controlled diabetic patients with HBA1C limit less than 7 If using concomitant medications and the subject condition is stable the subject must agree to remain on a stable dose of his or her concomitant medications throughout the study period or if the subjects condition is not stable then they must agree not to use concomitant medications Voluntarily participating in the clinical study fully understanding and being fully informed of the study and having signed the Informed Consent Form willingness and capability to complete all the study procedures.
排除标准
- •Subjects who have used ophthalmic topical or systemic cyclosporine in the past 90 days.
- •Subjects with Schirmer readings less than 2 mm/5 min without anesthesia in both eyes after stimulation thereby indicating end stage lacrimal gland disease.
- •Subjects with active ocular infection or ocular inflammation due to autoimmune disease like Sjogrens disease etc Subjects with lipid-deficient dry eyes like Meibomitis or Meibomian gland disease Subjects with history of recurrent herpes keratitis or active disease within the last six months.
- •Subjects with corneal disorder or abnormality that effects corneal sensitivity or normal spreading of the tear film.
- •Subjects with severe blepharitis or obvious inflammation of the lid margin which in the judgment of the investigator may interfere with the interpretation of the study results.
- •Subjects who had plug placement (laser, cautery, silicone, or collagen implant) within one month prior to the screening visit Subjects who use Pilocarpine or antihistamines more than 3 times a week Subject who have uncontrolled systemic disease (e.g., hypertension, diabetes) or the presence of any significant illness (e.g., serious gastrointestinal, renal, hepatic, endocrine, pulmonary, cardiac, neurologic disease, cancer, AIDS, or cerebral dysfunction) that could in the judgment of the investigator interfere with interpretation of the study results.
结局指标
主要结局
Comparison of length of wetting of the Schrimer’s test strips after five minutes, providing mean value for left/right eye from Baseline to EOT
时间窗: 70 days
Improvement in Dry eye condition between both the arms from baseline to EOT by DEQS
时间窗: 70 days
Follow up will be done at 70 days +/- 3 days for the well-being of the patient.
时间窗: 70 days
次要结局
- Comparison of Dry eye Eye fatigue level by VAS between both the arms from baseline to EOT(Comparison of Tear Breakup time test from baseline to EOT between both the arms)
研究者
研究点 (3)
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