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

Phase 3

Completed

Conditions: Health Condition 1: null- GlaucomaOcular HypertensionHealth Condition 2: H401- Open-angle glaucoma

Registration Number: CTRI/2011/11/002160

Lead Sponsor: Merck Sharp and Dohme

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 248

Inclusion Criteria

Patient has been diagnosed with primary open-angle glaucoma pigmentary glaucoma capsular glaucoma/pseudoexfoliation or ocular hypertension

- Patient 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)

- Patient is able to discontinue all topical and/or systemic ocular hypotensive medication during the washout period (up to 4 week pre-study)

- Patient has a best-corrected early treatment of diabetic retinopathy study (ETDRS) visual acuity of 20/80 or better in each eye

- Patient is willing and able to avoid wearing contact lenses from 4 weeks prior to dosing with study medication through 24 hours after final dosing

- Patient is willing and able to self-administer or has an able person available on a daily basis to assist with administration of study medications

- Patient with reproductive potential must use highly effective methods of birth control (hormonal contraceptives intrauterine device diaphragm condoms and vasectomy) within the projected duration of the study

- Patient is able to refrigerate study drug at home

Exclusion Criteria

- Patient has a mean intra ocular pressure (IOP) greater than or equal to 36 mmHg in either eye at screening

- Patient is unable to use study medication in the affected eye(s)

- Patient has a history of any inflammatory ocular surface disease or a history of anterior or posterior uveitis in either eye within 6 months prior to screening

- Patient has a history of retinal detachment proliferative diabetic retinopathy or any progressive retinal disease

- Patient has significant visual field loss or evidence of progressive visual loss with in the last year

- Patient has had intraocular surgery in either eye in the last 4 months

- Patient has had any glaucoma surgery, refractive surgery, or penetrating keratoplasty in either eye

- Patient is currently on two or more anti-glaucoma medications (except Cosopt(TM) or its generic formulation)

- Patient has previously used tafluprost

- Patient has a history of cardiovascular disorder within 6 months of screening

- Patient has a history of bronchial asthma wheezing chronic obstructive pulmonary disease (COPD) or other pulmonary disease abnormal chest x-ray or has current active pneumonia

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean diurnal change in intra ocular pressure (IOP)Timepoint: From baseline to Week 4;Mean diurnal change in intra ocular pressure (IOP)Timepoint: From baseline to Week 4

Secondary Outcome Measures