COSOPT-S® Treatment Versus Acetazolamide Before Trabeculectomy

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01228149
• Other study ID #: 35131; EUDRA CT 2010-019975-30
• Status: Completed
• Phase: Phase 4
• First received: August 20, 2010
• Last updated: September 10, 2014
• Start date: August 2010
• Est. completion date: April 2014

Study information

• Verified date: September 2014
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Procedure:
• Trabeculectomy
Filtrating glaucoma surgery, preoperative treatment will be assessed.

Locations

Country	Name	City	State
Germany	Clinical Trial Site, Department of Ophthalmology, University Medical Center Johannes Gutenberg University Mainz	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Katrin Lorenz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean IOP reduction (?IOP) three months after trabeculectomy in comparison to the mean preoperative IOP	measurement of eye pressure in mmHg	12 weeks	No
Secondary	safety of both treatment arms	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	12 weeks	Yes