Clinical trial NCT01254604: Preservative-Free Tafluprost (MK-2452) for the Treatment of Open-Angle Glaucoma or Ocular Hypertension (MK-2452-002)
Official title: A Phase III, Randomized, Active Comparator-Controlled, Four-Week, Double-Masked Clinical Trial to Compare the Efficacy and Safety of Preservative-Free MK-2452 (0.0015%) and Preservative-Free Timolol Maleate (0.5%) in Patients With Open-Angle Glaucoma or Ocular Hypertension in India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Ocular Hypertension
Keywords: Tafluprost
Glaucoma
Ocular Hypertension
Timolol
Eye Disorder
Preservative-Free
Prostaglandin Analogue
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-12-06
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Mean Diurnal IOP Change From Baseline at Week 4 - Study Eye
timeFrame: Baseline and Week 4
measure: Number of Participants With an Adverse Event (AE)
timeFrame: Up to 14 days after Week 4 visit
measure: Number of Participants Who Discontinued Study Drug Due to an AE
timeFrame: Up to Week 4
Secondary outcomes:
measure: Number of Participants With ≥25% Reduction in IOP From Baseline to Week 4 - Study Eye
timeFrame: Baseline and Week 4
Other outcomes:
Locations:
Study officials:
References:
citation: Chabi A, Baranak C, Lupinacci R, Herring WJ. Preservative-free tafluprost in the treatment of open-angle glaucoma or ocular hypertension in India: a phase III clinical trial. Int J Clin Pract. 2016 Jul;70(7):577-86. doi: 10.1111/ijcp.12815. Epub 2016 Jun 13.