COSOPT-S® Treatment Versus Acetazolamide Before Trabeculectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Johannes Gutenberg University Mainz
Sponsor:
Information provided by (Responsible Party):
Katrin Lorenz, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01228149
First received: August 20, 2010
Last updated: December 6, 2012
Last verified: December 2012
  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



Estimated Enrollment: 60
Study Start Date: August 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Recruiting
Mainz, Germany, 55131
Contact: Katrin Lorenz, MD    0049 6131 17 ext 4069    lorenz@augen.klinik.uni-mainz.de   
Contact: Marcel Keilani, MD    0049 6131 17 ext 3612    keilani@augen.klinik.uni-mainz.de   
Principal Investigator: Katrin Lorenz, MD         
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: December 6, 2012
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
Ocular Hypertension
Eye Diseases
Acetazolamide
Dexamethasone
Ophthalmic Solutions
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Pharmaceutical Solutions
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 18, 2014