COSOPT-S® Treatment Versus Acetazolamide Before Trabeculectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Katrin Lorenz, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01228149
First received: August 20, 2010
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Glaucoma
Procedure: Trabeculectomy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • Mean IOP reduction (ΔIOP) three months after trabeculectomy in comparison to the mean preoperative IOP [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    measurement of eye pressure in mmHg


Secondary Outcome Measures:
  • safety of both treatment arms [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

    Safety and tolerability of both treatment arms Number of necessary 5FU injections and suture lyses Required number of needlings and reoperations Change in IOP between Visit 1 and 2 Comparison between both groups of ocular hypotension rate and filtration bleb classification in both groups at every postoperative visit.

    Change in quality of life for the two therapeutical regimens in both groups Patients' satisfaction with pharmacologic intervention for IOP lowering



Enrollment: 65
Study Start Date: August 2010
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Acetazolamide
Patients receive oral acetazolamide starting 28 days preoperatively. 7 days preoperatively dexamethasone eyedrops without preservatives are applied additionally.
Procedure: Trabeculectomy
Filtrating glaucoma surgery, preoperative treatment will be assessed.
Other Name: Filtrating glaucoma surgery
Experimental: Cosopt S
Patients receive Cosopt S eye drops starting 28 days preoperatively
Procedure: Trabeculectomy
Filtrating glaucoma surgery, preoperative treatment will be assessed.
Other Name: Filtrating glaucoma surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01228149

Locations
Germany
Clinical Trial Site, Department of Ophthalmology, University Medical Center Johannes Gutenberg University Mainz
Mainz, Germany, 55131
Sponsors and Collaborators
Katrin Lorenz
Investigators
Principal Investigator: Katrin Lorenz, MD Johannes Gutenberg University Mainz
  More Information

No publications provided

Responsible Party: Katrin Lorenz, MD, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01228149     History of Changes
Other Study ID Numbers: 35131; EUDRA CT 2010-019975-30
Study First Received: August 20, 2010
Last Updated: September 10, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johannes Gutenberg University Mainz:
glaucoma
trabeculectomy
intraocular pressure

Additional relevant MeSH terms:
Glaucoma
Eye Diseases
Ocular Hypertension
Acetazolamide
Anticonvulsants
Carbonic Anhydrase Inhibitors
Cardiovascular Agents
Central Nervous System Agents
Diuretics
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014