Clinical trial NCT01228149: COSOPT-S® Treatment Versus Acetazolamide Before Trabeculectomy
Official title: Investigation of the Efficacy and Safety of Preoperative Intraocular Pressure (IOP) Reduction With Preservative-free COSOPT-S® (Dorzolamide/Timolol, MSD) Eye Drops Versus Oral Acetazolamide and Dexamethasone Eye Drops
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Keywords: glaucoma
trabeculectomy
intraocular pressure
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2010-10-26
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The most common cause of post-trabeculectomy filtration failure is postoperative scarring. Long-term preoperative treatment with local antiglaucoma agents containing preservatives has an increased risk of post-operative scarring of the filtration bleb. Therefore many surgeons prepare their patients for planned trabeculectomy by discontinuing local antiglaucoma drugs, controlling IOP with oral acetazolamide, and treating the eye with local steroids.

Preservative-free COSOPT-S® eye drops b.i.d now provide a possibility to reduce IOP preoperatively with the aim of avoiding postoperative excessive scarring and the known adverse effects of oral acetazolamide while achieving comparable IOP reduction and long-term outcomes.

This study will investigate comparability (non-inferiority) of medical benefits of two different IOP lowering pharmaceutical interventions prior to trabeculectomy comparing COSOPT-S® bid to oral acetazolamide plus dexamethasone.

Detailed description: The most common cause of post-trabeculectomy filtration failure is postoperative scarring. Long-term preoperative treatment with local antiglaucoma agents containing preservatives has an increased risk of post-operative scarring of the filtration bleb. Therefore many surgeons prepare their patients for planned trabeculectomy by discontinuing local antiglaucoma drugs, controlling IOP with oral acetazolamide, and treating the eye with local steroids.

Preservative-free COSOPT-S® eye drops b.i.d now provide a possibility to reduce IOP preoperatively with the aim of avoiding postoperative excessive scarring and the known adverse effects of oral acetazolamide while achieving comparable IOP reduction and long-term outcomes.

This study will investigate comparability (non-inferiority) of medical benefits of two different IOP lowering pharmaceutical interventions prior to trabeculectomy comparing COSOPT-S® bid to oral acetazolamide plus dexamethasone.

Eligibility 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
* Planned trabeculectomy
* 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

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 sclerocorneal 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
* Depressed blood levels of sodium and / or potassium
* Marked kidney and liver disease or dysfunction, gout, suprarenal gland failure, hypercalciuria or nephrocalcinosis
* History of hypersensitivity to the investigational medicinal products or to any drug

Primary outcomes:
measure: Change in Intraocular Pressure (IOP) (ΔIOP) Three Months After Trabeculectomy in Comparison to the Mean Preoperative IOP
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Needling
timeFrame: 12 weeks
measure: Number of Necessary 5-Fluorouracil (5FU) Injections
timeFrame: 12 weeks
measure: Ocular Hypotension Rate
timeFrame: 24 weeks
measure: Change in IOP Between Visit 1 and 2
timeFrame: 28 days
measure: Filtration Bleb Classification
timeFrame: 24 weeks
measure: Change in Quality of Life
timeFrame: 12 weeks
measure: Change in Conjunctival Redness
timeFrame: 24 weeks
measure: Number of Suture Lyses
timeFrame: week 12
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Clinical Trial Site, Department of Ophthalmology, University Medical Center Johannes Gutenberg University Mainz
Study officials:
affiliation: Johannes Gutenberg University Mainz
name: Katrin Lorenz, MD
role: PRINCIPAL_INVESTIGATOR
References: