Trial · NCT01228149
COSOPT-S® Treatment Versus Acetazolamide Before Trabeculectomy
NCT01228149, Phase 4, Completed, Katrin Lorenz; results first posted 2017-04-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. COSOPT-S® Treatment Versus Acetazolamide Before Trabeculectomy. Trials, record NCT01228149. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01228149
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- COSOPT-S® Treatment Versus Acetazolamide Before Trabeculectomy
- NCT number
- NCT01228149
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 62 participants, actual
- Lead sponsor
- Katrin Lorenz
- Conditions
- Glaucoma
- Interventions
- Trabeculectomy with preoperative Diamox/DexaEDO treatment, Trabeculectomy with preoperative Cosopt S treatment
- First posted
- 2010-10-26
- Last updated
- 2017-08-01
- Results first posted
- 2017-04-14
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Intraocular Pressure (IOP) (ΔIOP) Three Months After Trabeculectomy in Comparison to the Mean Preoperative IOP | 12 weeks | Change in IOP (ΔIOP) three months after trabeculectomy in comparison to the mean preoperative IOP at one day prior surgery |
| Secondary | Number of Needling | 12 weeks | number of patients requirering needling |
| Secondary | Number of Necessary 5-Fluorouracil (5FU) Injections | 12 weeks | Number of post-operative necessary 5-Fluorouracil (5FU) injections at week 12 |
| Secondary | Ocular Hypotension Rate | 24 weeks | Ocular hypotension rate (0-5 mmHg of the study eye) indicated by the number of patients with ocular hypertension |
| Secondary | Change in IOP Between Visit 1 and 2 | 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. |
| Secondary | Filtration Bleb Classification | 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. |
| Secondary | Change in Quality of Life | 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. |
| Secondary | Change in Conjunctival Redness | 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. |
| Secondary | Number of Suture Lyses | week 12 | Number of suture lyses at visit 5 (week 12 after surgery) |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Intraocular Pressure (IOP) (ΔIOP) Three Months After Trabeculectomy in Comparison to the Mean Preoperative IOP | 12 weeks | 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 | mmHg | MEAN |
| SECONDARY | Number of Needling | 12 weeks | Patients of the PP population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Necessary 5-Fluorouracil (5FU) Injections | 12 weeks | PP Population (n=58) | number of injections | MEAN |
| SECONDARY | Ocular Hypotension Rate | 24 weeks | PP Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in IOP Between Visit 1 and 2 | 28 days | PP Population | mmHg | MEAN |
| SECONDARY | Filtration Bleb Classification | 24 weeks | PP Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Quality of Life | 12 weeks | ITT Population | scores on a scale | MEAN |
| SECONDARY | Change in Conjunctival Redness | 24 weeks | ITT population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Suture Lyses | week 12 | Intention-to- treat population | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Intraocular Pressure (IOP) (ΔIOP) Three Months After Trabeculectomy in Comparison to the Mean Preoperative IOP | Diamox/DexaEDO | 8.30 | 95% Confidence Interval 6.85 to 9.75 | mmHg | |
| Change in Intraocular Pressure (IOP) (ΔIOP) Three Months After Trabeculectomy in Comparison to the Mean Preoperative IOP | Cosopt S | 8.12 | 95% Confidence Interval 6.67 to 9.58 | mmHg | |
| Number of Needling | Diamox/DexaEDO | 0 | Participants | ||
| Number of Needling | Cosopt S | 2 | Participants | ||
| Number of Necessary 5-Fluorouracil (5FU) Injections | Diamox/DexaEDO | 5.14 | Standard Deviation 2.61 | number of injections | |
| Number of Necessary 5-Fluorouracil (5FU) Injections | Cosopt S | 5.26 | Standard Deviation 3.13 | number of injections | |
| Ocular Hypotension Rate | Diamox/DexaEDO | 5 | Participants | ||
| Ocular Hypotension Rate | Cosopt S | 3 | Participants | ||
| Change in IOP Between Visit 1 and 2 | Diamox/DexaEDO | 8.19 | 95% Confidence Interval 5.77 to 10.61 | mmHg | |
| Change in IOP Between Visit 1 and 2 | Cosopt S | 1.88 | 95% Confidence Interval -0.59 to 4.34 | mmHg |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Diamox/DexaEDO | 32 | |
| Overall Study | STARTED | Cosopt S | 30 | |
| Overall Study | COMPLETED | Diamox/DexaEDO | 27 | |
| Overall Study | COMPLETED | Cosopt S | 26 | |
| Overall Study | NOT COMPLETED | Diamox/DexaEDO | 5 | |
| Overall Study | NOT COMPLETED | Cosopt S | 4 |
Source ClinicalTrials.gov
Adverse events144
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Visual acuity reduced | Eye disorders | Diamox/DexaEDO | 15 | 31 | |
| other | Visual acuity reduced | Eye disorders | Cosopt S | 15 | 28 | |
| other | Paraesthesia | Nervous system disorders | Diamox/DexaEDO | 14 | 31 | |
| other | Paraesthesia | Nervous system disorders | Cosopt S | 0 | 28 | |
| other | Headache | Nervous system disorders | Diamox/DexaEDO | 3 | 31 | |
| other | Headache | Nervous system disorders | Cosopt S | 2 | 28 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Diamox/DexaEDO | 5 | 31 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Cosopt S | 0 | 28 | |
| other | Foreign body in eye | Injury, poisoning and procedural complications | Diamox/DexaEDO | 0 | 31 | |
| other | Foreign body in eye | Injury, poisoning and procedural complications | Cosopt S | 1 | 28 |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Diamox/DexaEDO | ||
| Total, all-cause mortality | Cosopt S | ||
| Total, other adverse events | Diamox/DexaEDO | 30 | 31 |
| Total, other adverse events | Cosopt S | 23 | 28 |
| Total, serious adverse events | Diamox/DexaEDO | 4 | 31 |
| Total, serious adverse events | Cosopt S | 3 | 28 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Diamox/DexaEDO vs Cosopt S: Number of Needling | Trial comparisons |
| Diamox/DexaEDO vs Cosopt S: Ocular Hypotension Rate | Trial comparisons |
| Diamox/DexaEDO vs Cosopt S: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01228149
GET https://conductscience.org/api/trials/v1/NCT01228149/results?page=2