COSOPT-S® Treatment Versus Acetazolamide Before Trabeculectomy

NCT01228149 | Completed Phase 4 Results DMC

• 1 other identifier: 35131; EUDRA CT 2010-019975-30
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glaucoma

Keywords

glaucoma; trabeculectomy; intraocular pressure

Outcome Measures

Primary Outcomes (1)

• Change in Intraocular Pressure (IOP) (ΔIOP) Three Months After Trabeculectomy in Comparison to the Mean Preoperative IOP

  Change in IOP (ΔIOP) three months after trabeculectomy in comparison to the mean preoperative IOP at one day prior surgery

  12 weeks

Secondary Outcomes (8)

• Number of Needling

  12 weeks

• Number of Necessary 5-Fluorouracil (5FU) Injections

  12 weeks

• Ocular Hypotension Rate

  24 weeks

• Change in IOP Between Visit 1 and 2

  28 days

• Filtration Bleb Classification

  24 weeks

Study Arms (2)

Diamox/DexaEDO

ACTIVE COMPARATOR

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

Cosopt S

EXPERIMENTAL

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

Drug: Trabeculectomy with preoperative Cosopt S treatment

Interventions

Trabeculectomy with preoperative Diamox/DexaEDO treatment DRUG

Filtrating glaucoma surgery, preoperative treatment with Diamox (acetazolamide) 28 day prior surgery. DexaEDO (dexamethasone) 7 days prior surgery

Also known as: Filtrating glaucoma surgery

Diamox/DexaEDO

Trabeculectomy with preoperative Cosopt S treatment DRUG

Filtrating glaucoma surgery, preoperative treatment with Cosopt S (dorzolamide/timolol) 28 day prior surgery.

Also known as: Filtrating glaucoma surgery

Cosopt S

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Katrin Lorenz: lead

Study Sites (1)

Clinical Trial Site, Department of Ophthalmology, University Medical Center Johannes Gutenberg University Mainz

Mainz, 55131, Germany

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Dr. Katrin Lorenz
• Organization: Dept. of Ophthalmology, University Medical Center Mainz

lorenz@augen.klinik.uni-mainz.de

00496131174069

Study Officials

• Katrin Lorenz, MD

  Johannes Gutenberg University Mainz

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 20, 2010
• First Posted: October 26, 2010
• Study Start: August 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: August 1, 2017
• Results First Posted: April 14, 2017

Record last verified: 2017-03

Locations

DE (1)