Phase 3
Completed N=190
Preservative-Free Tafluprost (MK-2452) for the Treatment of Open-Angle Glaucoma or Ocular Hypertension (MK-2452-002)
Source: ClinicalTrials.gov NCT01254604 ↗Enrolled (actual)
190
Serious AEs
0.5%
Results posted
May 2014
Primary outcomePrimary: Mean Diurnal IOP Change From Baseline at Week 4 - Study Eye — -8.3; -6.6 mmHg
Summary
This study will test the hypothesis that preservative-free tafluprost (MK-2452) is non-inferior to preservative-free timolol maleate with respect to the diurnal intraocular pressure (IOP) change from baseline after 4 weeks of therapy in participants with open-angle glaucoma or ocular hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Diurnal IOP Change From Baseline at Week 4 - Study Eye |
-8.3; -6.6 | — |
| PRIMARY Number of Participants With an Adverse Event (AE) |
28; 32 | — |
| PRIMARY Number of Participants Who Discontinued Study Drug Due to an AE |
3; 2 | — |
| SECONDARY Number of Participants With ≥25% Reduction in IOP From Baseline to Week 4 - Study Eye |
65; 48 | — |
Eligibility Criteria
Inclusion Criteria
- Participant has been diagnosed with primary open-angle glaucoma, pigmentary glaucoma, capsular glaucoma/pseudoexfoliation, or ocular hypertension
- Has been using ocular hypotensive medication on a stable treatment regimen for at least 30 days prior to screening, or is treatment-naive (has never used or has not used ocular hypotensive medication for the last 4 weeks prior to screening)
- Able to discontinue all topical and/or systemic ocular hypotensive medication during the washout period (up to 4 weeks pre-study)
- Best-corrected early treatment of diabetic retinopathy study (ETDRS) visual acuity of 20/80 or better in each eye
- Willing and able to avoid wearing contact lenses from 4 weeks prior to dosing with study medication through 24 hours after final dosing
- Willing and able to self-administer or has an able person available on a daily basis to assist with administration of study medications
- Participant with reproductive potential must agree to remain abstinent (unless abstinence is not a locally acceptable method of contraception) or use highly effective methods of birth control (hormonal contraceptives, intrauterine device, diaphragm, condoms and vasectomy) within the projected duration of the study
- Able to refrigerate study drug at home.
Exclusion Criteria
- Mean IOP >36 mmHg in either eye at screening
- Unable to use study medication in the affected eye(s)
- History of any inflammatory ocular surface disease or a history of anterior or posterior uveitis in either eye within 6 months prior to screening
- History of retinal detachment, proliferative diabetic retinopathy, or any progressive retinal disease
- Significant visual field loss or evidence of progressive visual loss within the last year
- Intraocular surgery in either eye in the last 4 months
- Any glaucoma surgery, refractive surgery, or penetrating keratoplasty in either eye
- Currently on two or more anti-glaucoma medications (except Cosopt™ or its generic formulation)
- Previously used tafluprost
- History of cardiovascular disorder within 6 months of screening
- History of bronchial asthma, wheezing, chronic obstructive pulmonary disease (COPD) or other pulmonary disease, abnormal chest x-ray, or has current active pneumonia.
Data sourced from ClinicalTrials.gov (NCT01254604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.