Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT01254604
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01254604
Study Brief:
Protocol Section:
NCT01254604