The purpose of this study is to evaluate the effect on 24-hour IOP reduction of netarsudil-latanoprost fixed combination in one eye compared to latanoprost alone in the contralateral eye, dosed daily, 1 drop at night (QD, PM) in adult subjects, at least 18 years of age, with open angle glaucoma (OAG) or ocular hypertension (OHT).
This will be a double-masked, paired-contralateral, descriptive study to evaluate the effect on 24-hour IOP reduction of netarsudil-latanoprost fixed combination in one eye compared to latanoprost alone in the contralateral eye, dosed daily, 1 drop at night (QD, PM) in adult subjects, at least 18 years of age, with open angle glaucoma (OAG) or ocular hypertension (OHT). Study medication will be administered for 14 consecutive days, although the total time of subject participation in the study (including washout from prior treatment, if necessary) may be up to 10 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Subjects will receive netarsudil-latanoprost fixed combination ophthalmic solution 0.02%/0.005% in one eye and compare it to latanoprost 0.005% in the contralateral eye
latanoprost 0.005% solution will be applied in the contralateral eye, once daily, QD (PM) for 14 days
Mayo Clinic in Rochester
Rochester, Minnesota, United States
RECRUITINGChange in mean Intraocular Pressure (IOP)
Change in mean IOP from baseline at each time point for Latanoprost
Time frame: Change in mean IOP after 2 weeks of treatment with Latanoprost compared to baseline
Change in mean IOP
Change in mean IOP from baseline at each time point for Rocklatan
Time frame: Change in mean IOP after 2 weeks of treatment with Rocklatan compared to baseline
Change in mean IOP
Change in mean IOP from Latanoprost at each time point for Rocklatan
Time frame: Change in mean IOP from baseline after 2 weeks of treatment with latanoprost minus change in mean IOP from baseline after 2 weeks of treatment with Rocklatan
Change in mean nocturnal IOP
Change in mean nocturnal IOP (both absolute and % change) from baseline for Latanoprost
Time frame: Mean nocturnal IOP will be calculated based on the time points during the sleeping hours (11 PM - 7 AM) after 2 weeks of treatment with Latanoprost compared to baseline
Change in mean nocturnal IOP
Change in mean nocturnal IOP (both absolute and % change) from baseline for Rocklatan
Time frame: Mean nocturnal IOP will be calculated based on the time points during the sleeping hours (11 PM - 7 AM) after 2 weeks of treatment with Rocklatan compared to baseline
Change in mean diurnal IOP
Change in mean diurnal IOP (both absolute and % change) from baseline for Latanoprost
Time frame: Mean diurnal IOP will be calculated based on the time points during the sleeping hours (7 AM - 11 PM) after 2 weeks of treatment with Latanoprost compared to baseline
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Change in mean diurnal IOP
Change in mean diurnal IOP (both absolute and % change) from baseline for Rocklatan
Time frame: Mean diurnal IOP will be calculated based on the time points during the sleeping hours (7 AM - 11 PM) after 2 weeks of treatment with Rocklatan compared to baseline