NCT01026831

Preservative-Free MK2452 (Tafluprost) for Open-Angle Glaucoma/Ocular Hypertension (MK2452-001)(COMPLETED)

Completed Phase 3 Results posted Last updated 21 June 2017

What this trial tests

Phase 3 trial testing Preservative-Free Tafluprost in Open-angle Glaucoma in 643 participants. Completed in 17 September 2010.

Timeline

6 January 2010

Primary endpoint
17 September 2010

17 September 2010

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	643
Start date	6 January 2010
Primary completion	17 September 2010
Estimated completion	17 September 2010

Drugs / interventions tested

• Preservative-Free Tafluprost — full drug profile →
• Comparator: timolol — full drug profile →

Conditions studied

• Open-angle Glaucoma — all drugs for Open-angle Glaucoma →
• Ocular Hypertension — all drugs for Ocular Hypertension →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

18 and older, any sex, with Open-angle Glaucoma or Ocular Hypertension. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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) Primary · 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.

Week 2 - 0800 (n=280; n=295)

Group	Value	95% CI
Tafluprost	-7.1	-7.5 – -6.8
Timolol Maleate	-6.8	-7.1 – -6.5

Week 2 - 1000 (n=293; n=305)

Group	Value	95% CI
Tafluprost	-6.8	-7.1 – -6.5
Timolol Maleate	-6.1	-6.4 – -5.8

Week 2 - 1600 (n=289; n=302)

Group	Value	95% CI
Tafluprost	-6.2	-6.5 – -5.9
Timolol Maleate	-5.3	-5.7 – -5.0

Week 6 - 0800 (n=294; n=308)

Group	Value	95% CI
Tafluprost	-7.3	-7.6 – -6.9
Timolol Maleate	-7.4	-7.7 – -7.1

Week 6 - 1000 (n=298; n=312)

Group	Value	95% CI
Tafluprost	-7.0	-7.3 – -6.7
Timolol Maleate	-6.6	-6.9 – -6.3

Week 6 - 1600 (n=295; n=310)

Group	Value	95% CI
Tafluprost	-6.3	-6.7 – -6.0
Timolol Maleate	-5.5	-5.9 – -5.2

Week 12 - 0800 (n=296; n=308)

Group	Value	95% CI
Tafluprost	-7.4	-7.8 – -7.1
Timolol Maleate	-7.5	-7.8 – -7.1

Week 12 - 1000 (n=298; n=312)

Group	Value	95% CI
Tafluprost	-7.0	-7.4 – -6.7
Timolol Maleate	-6.6	-7.0 – -6.3

Baseline IOP Secondary · 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).

Baseline 0800 timepoint (n=299; n=313)

Group	Value	95% CI
Tafluprost	26.1	25.8 – 26.4
Timolol Maleate	26.0	25.7 – 26.2

Baseline 1000 timepoint (n=299; n=313)

Group	Value	95% CI
Tafluprost	24.8	24.5 – 25.2
Timolol Maleate	24.6	24.2 – 24.9

Baseline 1600 timepoint (n=296; n=312)

Group	Value	95% CI
Tafluprost	23.8	23.4 – 24.2
Timolol Maleate	23.5	23.2 – 23.9

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tafluprost

Serious: 2/320 (1%)

Deaths: —

Timolol Maleate

Serious: 7/323 (2%)

Deaths: —

Serious adverse events (9 terms)

Reaction	System	Tafluprost	Timolol Maleate
atrial fibrillation	Cardiac disorders	—	—
myocardial infarction	Cardiac disorders	—	—
retinal detachment	Eye disorders	—	—
colitis	Gastrointestinal disorders	—	—
hernia	General disorders	—	—
fracture	Injury, poisoning and procedural complications	—	—
joint dislocation	Injury, poisoning and procedural complications	—	—
tendon rupture	Injury, poisoning and procedural complications	—	—
pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: atrial fibrillation, myocardial infarction, retinal detachment, colitis, hernia, fracture, joint dislocation, tendon rupture.

Data from ClinicalTrials.gov NCT01026831 adverse events section.

Sponsor's own description

This study was to compare the safety and efficacy of the preservative-free formulation of 0.0015% MK2452 (tafluprost) and preservative-free 0.5% timolol maleate in patients with open-angle glaucoma and ocular hypertension. This study was to demonstrate that the preservative-free formulation of 0.0015% tafluprost is non-inferior to preservative-free 0.5% timolol maleate.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.