Back to resultsCOSOPT-S® Treatment Versus Acetazolamide Before Trabeculectomy
Primary Purpose
Glaucoma
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Trabeculectomy with preoperative Diamox/DexaEDO treatment
Trabeculectomy with preoperative Cosopt S treatment
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring glaucoma, trabeculectomy, intraocular pressure
Eligibility 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
Sites / Locations
- Clinical Trial Site, Department of Ophthalmology, University Medical Center Johannes Gutenberg University Mainz
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Diamox/DexaEDO
Cosopt S
Arm 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.
Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days before trabeculectomy.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Number of Needling
number of patients requirering needling
Number of Necessary 5-Fluorouracil (5FU) Injections
Number of post-operative necessary 5-Fluorouracil (5FU) injections at week 12
Ocular Hypotension Rate
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
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
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
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
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
Number of suture lyses at visit 5 (week 12 after surgery)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01228149
Brief Title
COSOPT-S® Treatment Versus Acetazolamide Before Trabeculectomy
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Katrin Lorenz
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
glaucoma, trabeculectomy, intraocular pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diamox/DexaEDO
Arm Type
Active Comparator
Arm 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.
Arm Title
Cosopt S
Arm Type
Experimental
Arm Description
Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days before trabeculectomy.
Intervention Type
Drug
Intervention Name(s)
Trabeculectomy with preoperative Diamox/DexaEDO treatment
Other Intervention Name(s)
Filtrating glaucoma surgery
Intervention Description
Filtrating glaucoma surgery, preoperative treatment with Diamox (acetazolamide) 28 day prior surgery. DexaEDO (dexamethasone) 7 days prior surgery
Intervention Type
Drug
Intervention Name(s)
Trabeculectomy with preoperative Cosopt S treatment
Other Intervention Name(s)
Filtrating glaucoma surgery
Intervention Description
Filtrating glaucoma surgery, preoperative treatment with Cosopt S (dorzolamide/timolol) 28 day prior surgery.
Primary Outcome Measure Information:
Title
Change in Intraocular Pressure (IOP) (ΔIOP) Three Months After Trabeculectomy in Comparison to the Mean Preoperative IOP
Description
Change in IOP (ΔIOP) three months after trabeculectomy in comparison to the mean preoperative IOP at one day prior surgery
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of Needling
Description
number of patients requirering needling
Time Frame
12 weeks
Title
Number of Necessary 5-Fluorouracil (5FU) Injections
Description
Number of post-operative necessary 5-Fluorouracil (5FU) injections at week 12
Time Frame
12 weeks
Title
Ocular Hypotension Rate
Description
Ocular hypotension rate (0-5 mmHg of the study eye) indicated by the number of patients with ocular hypertension
Time Frame
24 weeks
Title
Change in IOP Between Visit 1 and 2
Description
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.
Time Frame
28 days
Title
Filtration Bleb Classification
Description
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.
Time Frame
24 weeks
Title
Change in Quality of Life
Description
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.
Time Frame
12 weeks
Title
Change in Conjunctival Redness
Description
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.
Time Frame
24 weeks
Title
Number of Suture Lyses
Description
Number of suture lyses at visit 5 (week 12 after surgery)
Time Frame
week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katrin Lorenz, MD
Organizational Affiliation
Johannes Gutenberg University Mainz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Trial Site, Department of Ophthalmology, University Medical Center Johannes Gutenberg University Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
12. IPD Sharing Statement
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COSOPT-S® Treatment Versus Acetazolamide Before Trabeculectomy
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