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COSOPT-S® Treatment Versus Acetazolamide Before Trabeculectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01228149
First Posted: October 26, 2010
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Katrin Lorenz, Johannes Gutenberg University Mainz
August 20, 2010
October 26, 2010
April 27, 2015
April 14, 2017
August 1, 2017
August 2010
April 2014   (Final data collection date for primary outcome measure)
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
Mean IOP reduction (ΔIOP) three months after trabeculectomy in comparison to the mean preoperative IOP [ Time Frame: 12 weeks ]
measurement of eye pressure in mmHg
Complete list of historical versions of study NCT01228149 on ClinicalTrials.gov Archive Site
  • 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 is best and 6 worse). Every single item/score is transformed to a scale between 0 and 100 (0 best, 100 worse). 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)
Safety of Both Treatment Arms [ Time Frame: 12 weeks ]

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

Not Provided
Not Provided
 
COSOPT-S® Treatment Versus Acetazolamide Before Trabeculectomy
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Glaucoma
  • 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
  • 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
  • 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.
    Intervention: Drug: Trabeculectomy with preoperative Diamox/DexaEDO treatment
  • Experimental: Cosopt S
    Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days before trabeculectomy.
    Intervention: Drug: Trabeculectomy with preoperative Cosopt S treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
April 2014
April 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01228149
35131; EUDRA CT 2010-019975-30
Yes
Not Provided
Not Provided
Katrin Lorenz, Johannes Gutenberg University Mainz
Katrin Lorenz
Not Provided
Principal Investigator: Katrin Lorenz, MD Johannes Gutenberg University Mainz
Johannes Gutenberg University Mainz
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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