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Clinical Trials/EUCTR2010-019975-30-DE
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.

Registry
who.int
Start Date
June 25, 2010
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversity Medical Center, Johannes Gutenberg-University Mainz

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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