Trial · NCT01026831
Preservative-Free MK2452 (Tafluprost) for Open-Angle Glaucoma/Ocular Hypertension (MK2452-001)(COMPLETED)
NCT01026831, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2011-09-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Preservative-Free MK2452 (Tafluprost) for Open-Angle Glaucoma/Ocular Hypertension (MK2452-001)(COMPLETED). Trials, record NCT01026831. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01026831
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Preservative-Free MK2452 (Tafluprost) for Open-Angle Glaucoma/Ocular Hypertension (MK2452-001)(COMPLETED)
- NCT number
- NCT01026831
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 643 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Interventions
- Preservative-Free Tafluprost, Comparator: timolol
- First posted
- 2009-12-04
- Last updated
- 2017-06-21
- Results first posted
- 2011-09-13
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12) | Baseline, Weeks 2, 6, and 12. | IOP was measured using a Goldmann applanation tonometer. The primary evaluation was based on the study eye (the worse eye based on the 0800 hour IOP baseline or the right eye when both eyes had the same IOP). IOP change from baseline was calculated using the baseline IOP at each time point (0800 hours at baseline to 0800 hours at Week 2, 6, and 12; 1000 hours at baseline to 1000 hours at Week 2, 6, and 12; 1600 hours at baseline to 1600 hours at Week 2, 6, and 12). Lowering elevated IOP is a treatment goal of glaucoma. |
| Other | Baseline IOP | Baseline | IOP was measured using a Goldmann applanation tonometer. The primary evaluation was based on the study eye (the worse eye based on the 0800 hour IOP baseline or the right eye when both eyes had the same IOP). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12) | Baseline, Weeks 2, 6, and 12. | The Per-Protocol (PP) approach excluded all patients with important protocol violations and was performed for the efficacy endpoints. The PP population excluded patients due to important deviations from the protocol that may have substantially affected the results of the primary endpoints. | mmHg | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Baseline IOP | Baseline | The Per-Protocol (PP) approach excluded all patients with important protocol violations and was performed for the efficacy endpoints. The PP population excluded patients due to important deviations from the protocol that may have substantially affected the results of the primary endpoints. | mmHg | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12) | Tafluprost | Week 2 - 0800 (n=280; n=295) | -7.1 | 95% Confidence Interval -7.5 to -6.8 | mmHg |
| Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12) | Timolol Maleate | Week 2 - 0800 (n=280; n=295) | -6.8 | 95% Confidence Interval -7.1 to -6.5 | mmHg |
| Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12) | Tafluprost | Week 2 - 1000 (n=293; n=305) | -6.8 | 95% Confidence Interval -7.1 to -6.5 | mmHg |
| Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12) | Timolol Maleate | Week 2 - 1000 (n=293; n=305) | -6.1 | 95% Confidence Interval -6.4 to -5.8 | mmHg |
| Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12) | Tafluprost | Week 2 - 1600 (n=289; n=302) | -6.2 | 95% Confidence Interval -6.5 to -5.9 | mmHg |
| Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12) | Timolol Maleate | Week 2 - 1600 (n=289; n=302) | -5.3 | 95% Confidence Interval -5.7 to -5.0 | mmHg |
| Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12) | Tafluprost | Week 6 - 0800 (n=294; n=308) | -7.3 | 95% Confidence Interval -7.6 to -6.9 | mmHg |
| Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12) | Timolol Maleate | Week 6 - 0800 (n=294; n=308) | -7.4 | 95% Confidence Interval -7.7 to -7.1 | mmHg |
| Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12) | Tafluprost | Week 6 - 1000 (n=298; n=312) | -7.0 | 95% Confidence Interval -7.3 to -6.7 | mmHg |
| Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12) | Timolol Maleate | Week 6 - 1000 (n=298; n=312) | -6.6 | 95% Confidence Interval -6.9 to -6.3 | mmHg |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tafluprost | 320 | |
| Overall Study | STARTED | Timolol Maleate | 323 | |
| Overall Study | COMPLETED | Tafluprost | 306 | |
| Overall Study | COMPLETED | Timolol Maleate | 312 | |
| Overall Study | NOT COMPLETED | Tafluprost | 14 | |
| Overall Study | NOT COMPLETED | Timolol Maleate | 11 |
Source ClinicalTrials.gov
Adverse events18
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 |
|---|---|---|---|---|---|---|
| serious | atrial fibrillation | Cardiac disorders | Tafluprost | 1 | 320 | 1 |
| serious | atrial fibrillation | Cardiac disorders | Timolol Maleate | 1 | 323 | 1 |
| serious | myocardial infarction | Cardiac disorders | Tafluprost | 1 | 320 | 1 |
| serious | myocardial infarction | Cardiac disorders | Timolol Maleate | 0 | 323 | 0 |
| serious | retinal detachment | Eye disorders | Tafluprost | 0 | 320 | 0 |
| serious | retinal detachment | Eye disorders | Timolol Maleate | 1 | 323 | 1 |
| serious | colitis | Gastrointestinal disorders | Tafluprost | 0 | 320 | 0 |
| serious | colitis | Gastrointestinal disorders | Timolol Maleate | 1 | 323 | 1 |
| serious | hernia | General disorders | Tafluprost | 0 | 320 | 0 |
| serious | hernia | General disorders | Timolol Maleate | 1 | 323 | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tafluprost | ||
| Total, all-cause mortality | Timolol Maleate | ||
| Total, other adverse events | Tafluprost | 0 | 320 |
| Total, other adverse events | Timolol Maleate | 0 | 323 |
| Total, serious adverse events | Tafluprost | 2 | 320 |
| Total, serious adverse events | Timolol Maleate | 7 | 323 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22310086 | DERIVED |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Tafluprost vs Timolol Maleate: serious adverse events |
Source 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/NCT01026831
GET https://conductscience.org/api/trials/v1/NCT01026831/results?page=2