Patients with glaucoma requiring trabeculectomy (filtration surgery) MedDRA version: 12.1 Level: LLT Classification code 10018304 Term: Glaucoma MedDRA version: 12.1 Level: LLT Classification code 10050156 Term: Glaucoma surgery
Conditions
Interventions
Trade Name: Cosopt S
Pharmaceutical Form: Eye drops*
INN or Proposed INN: DORZOLAMIDE
CAS Number: 120279961
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration nu
Sponsors
University Medical Center, Johannes Gutenberg-University Mainz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Male or female patients aged 18 years or older •Caucasian •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
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 •History of hypersensitivity to the investigational medicinal products or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that COSOPT-S® b.i.d is not inferior to the standard regimen in terms of IOP reduction three months after trabeculectomy.;Secondary Objective: •To show that the tolerability and safety of COSOPT-S® b.i.d. is descriptively superior to that of reference therapy •Comparison of the regimen COSOPT-S® b.i.d. with the reference regimen in terms of postoperative complications and the filtration bleb status three months after trabeculectomy •Exploration of patients’ satisfaction and health care utilisation ;Primary end point(s): Mean IOP reduction (?IOP) three months after trabeculectomy in comparison to the mean preoperative IOP | — |
Countries
Germany
Outcome results
None listed