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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Cosopt S | Experimental | Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days before trabeculectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Needling | number of patients requirering needling | 12 weeks |
| Number of Necessary 5-Fluorouracil (5FU) Injections | Number of post-operative necessary 5-Fluorouracil (5FU) injections at week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katrin Lorenz, MD | Johannes Gutenberg University Mainz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site, Department of Ophthalmology, University Medical Center Johannes Gutenberg University Mainz | Mainz | 55131 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diamox/DexaEDO | Patients receive oral acetazolamide starting 28 days preoperatively. 7 days preoperatively dexamethasone eyedrops without preservatives are applied additionally. Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed. |
| FG001 | Cosopt S | Patients receive Cosopt S eye drops starting 28 days preoperatively Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diamox/DexaEDO | Patients receive Diamox (oral acetazolamide) starting 28 days preoperatively. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally. Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | In total 62 patients were randomized, 30 to COSOPT-S®, 32 to DIAMOX+Dexa edo® (intention-to-treat (ITT) population. Per-protocol (PP) population (treated >8 days and did not take any medication that interfered with the study): n=58 patients: 27 p. in COSOPT-S®, 31 p. in DIAMOX+Dexa edo®. Analysis population: patients who completed the study n=53 | Posted | Mean | 95% Confidence Interval | mmHg | 12 weeks |
|
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Adverse Event data were colleted from patients with at least one documented treatment with study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diamox/DexaEDO | Patients receive Diamox (oral acetazolamide) starting 28 days preoperatively. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally. Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorders | Cardiac disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual acuity reduced | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dr. Katrin Lorenz | Dept. of Ophthalmology, University Medical Center Mainz | 00496131174069 | lorenz@augen.klinik.uni-mainz.de |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014130 | Trabeculectomy |
| ID | Term |
|---|---|
| D018463 | Filtering Surgery |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| Trabeculectomy with preoperative Cosopt S treatment | Drug | Filtrating glaucoma surgery, preoperative treatment with Cosopt S (dorzolamide/timolol) 28 day prior surgery. |
|
|
| 12 weeks |
| Ocular Hypotension Rate | Ocular hypotension rate (0-5 mmHg of the study eye) indicated by the number of patients with ocular hypertension | 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. | 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:
For the change in the filtration bleb classification (only thickness at visit 5/week 12 mentioned below) descriptive statistics were presented only. | 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. | 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. | 24 weeks |
| Number of Suture Lyses | Number of suture lyses at visit 5 (week 12 after surgery) | week 12 |
| Cosopt S |
Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days preoperatively Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| OG001 | Cosopt S | Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days preoperatively Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed. |
|
|
| Secondary | Number of Needling | number of patients requirering needling | Patients of the PP population | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Number of Necessary 5-Fluorouracil (5FU) Injections | Number of post-operative necessary 5-Fluorouracil (5FU) injections at week 12 | PP Population (n=58) | Posted | Mean | Standard Deviation | number of injections | 12 weeks |
|
|
|
| Secondary | Ocular Hypotension Rate | Ocular hypotension rate (0-5 mmHg of the study eye) indicated by the number of patients with ocular hypertension | PP Population | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Secondary | 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. | PP Population | Posted | Mean | 95% Confidence Interval | mmHg | 28 days |
|
|
|
| Secondary | 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:
For the change in the filtration bleb classification (only thickness at visit 5/week 12 mentioned below) descriptive statistics were presented only. | PP Population | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Secondary | 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. | ITT Population | Posted | Mean | Standard Deviation | scores on a scale | 12 weeks |
|
|
|
| Secondary | 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. | ITT population | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Secondary | Number of Suture Lyses | Number of suture lyses at visit 5 (week 12 after surgery) | Intention-to- treat population | Posted | Count of Participants | Participants | week 12 |
|
|
|
| 4 |
| 31 |
| 30 |
| 31 |
| EG001 | Cosopt S | Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days preoperatively Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed. | 3 | 28 | 23 | 28 |
| Iris incaceration | Eye disorders |
|
| Iris neovascularisation | Eye disorders |
|
| Meniscus injury | Injury, poisoning and procedural complications |
|
| Intraocular pressure increased | Investigations |
|
| Musculoskeletal and connective tissue | Investigations |
|
| Osteoarthritis | Investigations |
|
| Neoplasm skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Haemorrhoid operation | Surgical and medical procedures |
|
| Paraesthesia | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Non-systematic Assessment |
|
| Foreign body in eye | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Atrial faibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Weight decreased | Investigations | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Blood pressure fluctuation | Vascular disorders | Non-systematic Assessment |
|
| Anxietry disorder | Psychiatric disorders | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Conjunctivitis bacterial | Infections and infestations | Non-systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| neoplasm skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Eye operation complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Corneal epithelial defect | Eye disorders | Systematic Assessment |
|
| erythema of eyelid | Eye disorders | Non-systematic Assessment |
|
| corneal erosion | Eye disorders | Systematic Assessment |
|
| eyelid oedema | Eye disorders | Non-systematic Assessment |
|
| intraocular pressure increased | Investigations | Systematic Assessment |
|
| corneal defect | Eye disorders | Systematic Assessment |
|
| conjunctival haemmorrhage | Eye disorders | Systematic Assessment |
|
| eye irritation | Eye disorders | Non-systematic Assessment |
|
| Hyphaema | Eye disorders | Non-systematic Assessment |
|
| Blepharitis | Eye disorders | Non-systematic Assessment |
|
| Choroidal detachment | Eye disorders | Non-systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | Non-systematic Assessment |
|
| Corneal oedema | Eye disorders | Non-systematic Assessment |
|
| Foreign body sensation in eye | Eye disorders | Non-systematic Assessment |
|
| Iris incaeceration | Eye disorders | Non-systematic Assessment |
|
| Iris Neovascularization | Eye disorders | Non-systematic Assessment |
|
| Keratitis | Eye disorders | Non-systematic Assessment |
|
| Lacrimation increased | Eye disorders | Non-systematic Assessment |
|
| Macular oedema | Eye disorders | Non-systematic Assessment |
|
| Scleral haemorrhage | Eye disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Drug intolerance | General disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Depressed mood | Psychiatric disorders | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Nervousness | Psychiatric disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Fungal infection | Infections and infestations | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Uterine polyp | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Haemorrhoid operation | Surgical and medical procedures | Non-systematic Assessment |
|
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| 1 mm |
|
| Flat |
|
| Missing |
|
| mild |
|
| moderate |
|
| severe |
|
| very severe |
|
| Visit 2 |
|
|
| 3-4 suture lyses |
|