The aim of this study is to evaluate the tolerance and effect on unmedicated subjects with elevated IOP.
The aim of this study is to evaluate the tolerance and effect on unmedicated subjects with elevated IOP. An unmedicated subject is considered a person without any IOP/glaucoma treatment at least one month before recruitment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
SYL040012 ophthalmic drops, daily single dose administration
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain
Clinica Universidad Navarra
Pamplona, Navarre, Spain
Tolerance on ocular surface (ocular and conjunctiva)
Local Tolerance and ocular surface(cornea and conjunctival) on the area of administration 24 hours after last administration of multiple dose during 7 days of administration. It will be performed using a slit lamp which will be performed before, during and after the administration at established times. Adverse events will be registered and the determination of subjective tolerance will use the visual analogical scale (VAS) in cases where a subjects refers them.
Time frame: 7 days + 24 hours
Tolerance, Adverse events, Pharmacokinetics and effect
Local Tolerance on the area of administration at 1 hour and 96 hours after the last administered dose: corneal pachymetry, rest of anterior exploration of the eye, visual acuity, eye fundus, clinical exam (including physical exploration, vital signs, analytical blood and urine test, and ECG. Other parameters: analytics, VAS evaluation, Evaluation of adverse event appearance Pharmacokinetics: SYL040012 blood absorption will be evaluated after topical ocular administration Effect on IOP
Time frame: 11 days
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