A randomized, open label, single center study to assess the safety and efficacy of Ultraviolet-C rays (4mJ/cm2) plus Methylene Blue eye drops (0.03%) vs standard treatment with antimicrobial drops in treatment for infectious keratitis.

Divyajyoti Trust0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1.Subjects 18 years of age or older.
•2.Patient exhibits clinical signs of corneal infiltrate or beginning corneal ulcer in at least one eye of suspected bacterial, fungal, viral or mixed (bacterial and fungal) origin.
•3.Infiltrates and early ulcers up to a maximum 6mm in diameter.
•4.No previous antibiotic/antifungal/ antiviral at least for a minimum of 48 hours from time of screening.
•5.Patient provides voluntary signed and dated informed consent.
•6.Patient willing to comply with all study procedures and be available for the duration of the study.

•1.Patients with bilateral infectious keratitis/corneal ulcers
•2.Suspicion of non-infectious keratitis, or acanthamoeba keratitis or sterile infiltrate.
•3.Patients who cannot comply in the treatment or be monitored with frequent clinician controls as required in the study protocol. Patient not willing to stay in the hospital for first three days of treatment.
•4.Corneal perforation
•5.Descemetocele
•6.Known or suspected G6PD deficiency
•7.Allergic reaction / sensitivity to methylene blue
•8.Pregnancy or breastfeeding
•9.Immunosuppressed/immune-compromised patients. Patients on corticosteroids by any route for any other disease. Taking anti-inflammatory drugs for any other disease by any route.
•10. Taking any antibiotic for any other disease by any route.
•11.Patients with diagnosed eczema (or atopic dermatitis)
•12.Previous keratoplasty
•13.Patients with monocular vision.
•14. Subjects with known history of clinically significant gastrointestinal, cardiovascular, hepatic, haematological, renal, respiratory, immunological, and neurological abnormalities, or disease which in opinion of investigator may interfere in the study compliance and assessments.
•15. Subjects who have participated in any other clinical trial Ã¢â?°Â¤1 months prior to screening.
•16. Subjects who are employees or relatives of the study site staff.

发起方

Divyajyoti Trust