Preservative-Free Tafluprost (MK-2452) for the Treatment of Open-Angle Glaucoma or Ocular Hypertension (MK-2452-002)

Condition(s) targeted: Glaucoma; Ocular Hypertension

Intervention: Preservative-Free Tafluprost or vehicle (Drug); Preservative-Free Timolol maleate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

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.

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Mean Diurnal IOP Change From Baseline at Week 4 - Study Eye

Number of Participants With an Adverse Event (AE)

Number of Participants Who Discontinued Study Drug Due to an AE

Secondary outcome: Number of Participants With ≥25% Reduction in IOP From Baseline to Week 4 - Study Eye

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Starting date: December 2011
Last updated: March 24, 2015