A THREE-MONTH DOUBLE-BLIND, MULTICENTRE, CONTROLLED STUDY COMPARING 2% DORZOLAMIDE, EYE DROPS, SOLUTION, AND OF 0.5% TIMOLOL,IN PAEDIATRIC PATIENTS OF LESS THAN 6 YEARS OF AGE WITH ELEVATED INTRAOCULAR PRESSURE OR GLAUCOMA

MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2002年1月10日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•1. Patients under 6 years old (approximately half will be <2 years and the other half will be> 2 years but <6 years).
•2. Pediatric glaucoma or suspected glaucoma with IOP> 22 mmHg in one or both eyes.
•3. Discontinuation of topical or systemic ocular hypotensive medication for at least 24 hours before Study Day 1
•4. Complete physical examination within 3 months prior to the start of the study.

•1. The patient is currently using contact lenses for continuous use
•2. Antecedents or evidence of goniotomy or trabeculotomy within the month prior to the start of the study, implant surgery or filtration within 3 months prior to the start of the study or cyclodestructive surgery within 3 months prior to the start of the study.
•3. Antecedents or evidence of significant ocular trauma within 3 months prior to the start of the study.
•4. Evidence of inflammation and / or acute or recent ocular infection within the month prior to the start of the study.
•5. Chronic conjunctivitis, chronic keratitis or lacrimal deficiency.
•6. Non-ocular systemic or concomitant topical medication known to affect intraocular pressure
•7. Participation in a study that involves a research drug within the previous 4 weeks.
•8. History of hypersensitivity to any component of dorzolamide or ophthalmic solutions of timolol SG; severe or serious hypersensitivity known to sulfonamides.
•9. Any contraindication to the use of timolol ophthalmic solutions SG
•10. History or evidence of impaired renal function.

发起方

MERCK SHARP & DOHME PERU S.R.L.,