EUCTR2010-019975-30-DE
Active, Not Recruiting
N/A
Investigation of the efficacy and safety of preoperative IOP reduction with preservative-free COSOPT-S® (dorzolamide/timolol, MSD) eye drops versus oral acetazolamide and dexamethasone eye drops and assessment of the clinical outcome of trabeculectomy in glaucoma patients - COSOPT-S® Study
niversity Medical Center, Johannes Gutenberg-University Mainz0 sitesJune 25, 2010
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Patients with glaucoma requiring trabeculectomy (filtration surgery)
- Sponsor
- niversity Medical Center, Johannes Gutenberg-University Mainz
- Status
- Active, Not Recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female patients aged 18 years or older
- •A clinical diagnosis of open angle glaucoma, pseudoexfoliation or pigment dispersion glaucoma, or ocular hypertension in one or both eyes
- •Previous treatment with antiglaucoma agents containing preservatives for at least one month
- •Best corrected visual acuity of 20/800 or better in the study eye
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Secondary glaucoma except pseudoexfoliation glaucoma and pigmentary glaucoma
- •Current ocular infection, i.e. conjunctivitis or keratitis
- •Any abnormality preventing reliable applanation tonometry
- •Intraocular surgery or laser treatment within the past three months
- •History of surgery involving the conjunctiva
- •History of cataract surgery with sklerocorneal approach
- •Subject is allergic to sulfonamides
- •Reactive airway disease, including bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease
- •Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock
- •Severe renal dysfunction (CrCl \< 30 ml/min) or hyperchloraemic acidosis
Outcomes
Primary Outcomes
Not specified
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