COSOPT-S® Treatment Versus Acetazolamide Before Trabeculectomy
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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 |
- 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
- 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 |
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| 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 | |
| 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 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 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 May 19, 2013