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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: March 3, 2017
Last verified: March 2017
  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
Drug: Trabeculectomy with preoperative Diamox/DexaEDO treatment
Drug: Trabeculectomy with preoperative Cosopt S treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • Change in Intraocular Pressure (IOP) (ΔIOP) Three Months After Trabeculectomy in Comparison to the Mean Preoperative IOP [ Time Frame: 12 weeks ]
    Change in IOP (ΔIOP) three months after trabeculectomy in comparison to the mean preoperative IOP at one day prior surgery


Secondary Outcome Measures:
  • Safety of Both Treatment Arms [ Time Frame: 12 weeks ]

    Safety and tolerability of both treatment arms Number of necessary 5-Fluorouracil (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: 62
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: Diamox/DexaEDO
Patients receive Diamox (oral acetazolamide) starting 28 days Prior to trabeculectomy. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally. Patient will undergo trabeculectomy.
Drug: Trabeculectomy with preoperative Diamox/DexaEDO treatment
Filtrating glaucoma surgery, preoperative treatment with Diamox (acetazolamide) 28 day prior surgery. DexaEDO (dexamethasone) 7 days prior surgery
Other Name: Filtrating glaucoma surgery
Experimental: Cosopt S
Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days before trabeculectomy.
Drug: Trabeculectomy with preoperative Cosopt S treatment
Filtrating glaucoma surgery, preoperative treatment with Cosopt S (dorzolamide/timolol) 28 day prior surgery.
Other Name: Filtrating glaucoma surgery

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Mainz, Germany, 55131
Sponsors and Collaborators
Katrin Lorenz
Investigators
Principal Investigator: Katrin Lorenz, MD Johannes Gutenberg University Mainz
  More Information

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
Results First Received: April 27, 2015
Last Updated: March 3, 2017

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

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Acetazolamide
Dorzolamide
Timolol
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Anti-Arrhythmia Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 23, 2017