This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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: May 29, 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 Katrin Lorenz, 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:
  • Number of Needling [ Time Frame: 12 weeks ]
    number of patients requirering needling

  • Number of Necessary 5-Fluorouracil (5FU) Injections [ Time Frame: 12 weeks ]
    Number of post-operative necessary 5-Fluorouracil (5FU) injections at week 12

  • Ocular Hypotension Rate [ Time Frame: 24 weeks ]
    Ocular hypotension rate (0-5 mmHg of the study eye) indicated by the number of patients with ocular hypertension

  • Change in IOP Between Visit 1 and 2 [ Time Frame: 28 days ]
    Change in IOP between Visit 1 (Screening visit 16 to 28 day prior trabeculectomy) and Visit 2 (1 day before trabeculectomy). Outcome shows mean of differences and 95% confidence intervall.

  • Filtration Bleb Classification [ Time Frame: 24 weeks ]

    Filtration bleb classification (Grehn) in both Groups 1 week, 4 weeks, 12 weeks and 24 week after surgery.

    For classification the following criteria were evaluated and scored as described below:

    • vascularisation (0=None, 1=mild, 2=a few corkscrew vessels)
    • identifiability (0=no borders to sides; 1=demarcation nasally or temporally; 2= demarcation to both sides; 3= encapsulated)
    • Thickness (0= a least 3mm; 1=2mm; 2= 1mm; 3=flat)
    • Microcysts (0=no; 1= yes)
    • Transparency (0= highly transparent; 2=moderate; 2=not transparent)
    • Mobility (0= yes; 1= no)
    • Leakage (0=yes, 1=no)

    For the change in the filtration bleb classification (only thickness at visit 5/week 12 mentioned below) descriptive statistics were presented only.


  • Change in Quality of Life [ Time Frame: 12 weeks ]

    Change in quality of life measure by a certified National Eye Institute Visual Functioning Questionnaire containing 25 questions (NEI VFQ-25).Patients tick a score at every question to present their visual functioning (usually from 1-5 or 1-6 in which 1 ist best and 6 worse). Every single item/score is transformed to a scale between 0 and 100. For the total score, the mean of all transformed scores/items is calculated.

    NEI VFQ 25 Quality of Life Questionnaire composite score at V5 (week 12 after surgery).

    Outcome shows mean of differences and 95% confidence intervall.


  • Change in Conjunctival Redness [ Time Frame: 24 weeks ]
    Conjunctival redness (ORA Scale) evaluated from 16 up to 28 days (time window) prior surgery and 1 day prior surgery. The investigator compares patient's study eye with a set of reference photos showing various degrees of redness. Redness was scored on a scale of "none", "mild", "moderate", "severe" and "very severe". Absolute and relative frequencies of visit 1 and 2 were compared descriptively.

  • Number of Suture Lyses [ Time Frame: week 12 ]
    Number of suture lyses at visit 5 (week 12 after surgery)


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: May 29, 2017

Keywords provided by Katrin Lorenz, 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
Dorzolamide
Acetazolamide
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 June 26, 2017