GlaucomaPhase 4NCT01228149
COSOPT-S® Treatment Versus Acetazolamide Before Trabeculectomy
A Phase 4 study testing Trabeculectomy with preoperative Diamox/DexaEDO treatment and Trabeculectomy with preoperative Cosopt S treatment in people with Glaucoma, run by Katrin Lorenz at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Trabeculectomy with preoperative Diamox/DexaEDO treatment and Trabeculectomy with preoperative Cosopt S treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2010to Apr 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
Germany1 site
Clinical Trial Site, Department of Ophthalmology, University Medical Center Johannes Gutenberg University Mainz
Mainz, 55131
About this study
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
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.
Read the 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.
- Conditions
- Glaucoma
- Being tested
- Trabeculectomy with preoperative Diamox/DexaEDO treatment, Trabeculectomy with preoperative Cosopt S treatment
- Keywords
- glaucoma, trabeculectomy, intraocular pressure
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trabeculectomy with preoperative Diamox/DexaEDO treatmentDrug
Also called Filtrating glaucoma surgery
Filtrating glaucoma surgery, preoperative treatment with Diamox (acetazolamide) 28 day prior surgery. DexaEDO (dexamethasone) 7 days prior surgery
Trabeculectomy with preoperative Cosopt S treatmentDrug
Also called Filtrating glaucoma surgery
Filtrating glaucoma surgery, preoperative treatment with Cosopt S (dorzolamide/timolol) 28 day prior surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Trabeculectomy with preoperative Diamox/DexaEDO treatment |
| Cosopt S | Experimental | Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days before trabeculectomy. Receives: Drug: Trabeculectomy with preoperative Cosopt S treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (8)
Number of Needling
number of patients requirering needling
Measured: 12 weeks
Number of Necessary 5-Fluorouracil (5FU) Injections
Number of post-operative necessary 5-Fluorouracil (5FU) injections at week 12
Measured: 12 weeks
Ocular Hypotension Rate
Ocular hypotension rate (0-5 mmHg of the study eye) indicated by the number of patients with ocular hypertension
Measured: 24 weeks
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.
Measured: 28 days
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.
Measured: 24 weeks
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.
Measured: 12 weeks
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.
Measured: 24 weeks
Number of Suture Lyses
Number of suture lyses at visit 5 (week 12 after surgery)
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Katrin Lorenz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Katrin Lorenz, Johannes Gutenberg University Mainz
- Investigators
- Katrin Lorenz, MD, Principal investigator, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228149
- Sponsor's protocol ID
- 35131; EUDRA CT 2010-019975-30
- Status last verified
- Mar 2017
- First submitted
- 20 Aug 2010
- Last updated
- 1 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01228149
- Acronym / sponsor ID
- 35131; EUDRA CT 2010-019975-30
- Conditions
- Glaucoma
- Keywords
- glaucoma, trabeculectomy, intraocular pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Katrin LorenzUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 26 Oct 2010 (estimated)
- Results
- Posted 14 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diamox/DexaEDO | Active comparator | Drug: Trabeculectomy with preoperative Diamox/DexaEDO treatmentPatients 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. |
| Cosopt S | Experimental | Drug: Trabeculectomy with preoperative Cosopt S treatmentPatients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days before trabeculectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trabeculectomy with preoperative Diamox/DexaEDO treatmentAlso: Filtrating glaucoma surgeryFiltrating glaucoma surgery, preoperative treatment with Diamox (acetazolamide) 28 day prior surgery. DexaEDO (dexamethasone) 7 days prior surgery | Drug | Diamox/DexaEDO |
| Trabeculectomy with preoperative Cosopt S treatmentAlso: Filtrating glaucoma surgeryFiltrating glaucoma surgery, preoperative treatment with Cosopt S (dorzolamide/timolol) 28 day prior surgery. | Drug | Cosopt S |
Primary outcome
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
8 secondary outcomes
Number of Needling
Time frame: 12 weeks
Number of Necessary 5-Fluorouracil (5FU) Injections
Time frame: 12 weeks
Ocular Hypotension Rate
Time frame: 24 weeks
Change in IOP Between Visit 1 and 2
Time frame: 28 days
Filtration Bleb Classification
Time frame: 24 weeks
Change in Quality of Life
Time frame: 12 weeks
Change in Conjunctival Redness
Time frame: 24 weeks
Number of Suture Lyses
Time frame: week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katrin Lorenz, MD principal investigator
Johannes Gutenberg University Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trabeculectomy with preoperative Diamox/DexaEDO treatment and Trabeculectomy with preoperative Cosopt S treatment in people with Glaucoma, run by Katrin Lorenz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intraocular Pressure (IOP) (ΔIOP) Three Months After Trabeculectomy in Comparison to the Mean Preoperative IOP (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.