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To evaluate the effect on trabecular outflow facility of Netarsudil ophthalmic solution 0.02% compared to placebo
Full description
Trabecular outflow facility is a measure of aqueous humor dynamics; effect of netarsudil on this parameter as well as on intraocular pressure and episcleral venous pressure was evaluated in this study. Netarsudil treatment was given in one eye and placebo given in contralateral eye for 7 consecutive days.
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Inclusion criteria
Exclusion criteria
Ophthalmic:
Clinically significant ocular disease
Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles
Intraocular pressure ≥30 mmHg in either eye
A difference in IOP between eyes >4mmHg at qualification visit
Use of more than two ocular hypotensive medications within 30 days of screening
Known hypersensitivity to any component of the formulation
Previous glaucoma surgery or refractive surgery
Keratorefractive surgery in either eye
Report of ocular injury in either eye within the six months prior to screening or ocular or non-refractive surgery within 3 months prior to screening
Recent or current ocular infection or inflammation in either eye
Use of ocular medication in either eye of any kind within 30 days of screening
Mean central corneal thickness greater than 620 μm in either eye
Any abnormality preventing reliable applanation tonometry of either eye
Lack of suitable episcleral vein prior to performing Episcleral Venus Pressure (EVP) measurement (applicable to 1 site only)
Systemic:
Clinically significant abnormalities within 6 weeks prior to screening
Clinically significant systemic disease
Participation in any investigational study within 60 days prior to screening
Use of systemic medication that could have an effect on intraocular pressure within 30 days prior to screening
Women of childbearing potential who were pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
Primary purpose
Allocation
Interventional model
Masking
20 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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