Safety, Tolerability and Pharmacokinetic Profile of SYL1801 Eye Drops

Safety, Tolerability and Pharmacokinetic Profile of Different Doses of SYL1801 Ophthalmic Solution in Healthy Volunteers

Study of the safety, tolerability and pharmacokinetic profile of different doses of SYL1801 eye drops in healthy volunteers.

Inclusion Criteria:

• Signed informed consent
• Body mass index (BMI) between 19.5 and 29.0 kg/m2
• Intraocular pressure (IOP) <=21 mmHg
• Best Corrected Visual Acuity (BCVA) >= 70 ETDRS
• Normal corneal and conjunctival assessment
• Normal funduscopy

Exclusion Criteria:

• Pregnant or breastfeeding females or those with a positive pregnancy test. Females of childbearing potential who will not use a medically acceptable contraceptive method
• Current relevant diseases according to the investigator's judgement.
• Previous relevant chronic processes according to the investigator's judgement
• Relevant visual alterations according to the investigator's judgement
• Administration of systemic medications
• Case history of hypersensitivity to medicinal products or any other allergic process
• Participation in any clinical study with an investigational drug/device within 3 months prior to the first day of dosing.