COSOPT-S® Treatment Versus Acetazolamide Before Trabeculectomy

Katrin Lorenz

Status and phase: Completed; Phase 4

Conditions: Glaucoma

Treatments: Drug: Trabeculectomy with preoperative Diamox/DexaEDO treatment; Drug: Trabeculectomy with preoperative Cosopt S treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01228149

35131 EUDRA CT 2010-019975-30;

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Diamox/DexaEDO

Active Comparator group

Description:

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.

Treatment:

Drug: Trabeculectomy with preoperative Diamox/DexaEDO treatment

Cosopt S

Experimental group

Description:

Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days before trabeculectomy.

Treatment:

Drug: Trabeculectomy with preoperative Cosopt S treatment