Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy Volunteers

Sylentis

Status and phase

Completed

Phase 1

Conditions

Ocular Pain

Dry Eye

Treatments

Drug: SYL1001

Study type

Interventional

Funder types

Industry

Identifiers

SYL1001_I

2010-023113-56 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine whether SYL1001 is safe for the prevention and treatment of ocular pain and dry eye syndrome.

Enrollment

30 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subjects must provide signed inform consent prior to participation.
BMI between 19,5 y 29 kg/m2.
Normal ocular test in both eyes: IOP </=21 mmHg. BCVAof >/=0,8 (20/25)Snellen scale, or </=0.1 LogMar.
Normal fluorescein Clearance Test in both eyes.
Normal funduscopy in both eyes.

Exclusion criteria

Pregnant or breastfeeding females or those with a positive pregnancy test or who will not use a medically acceptable contraceptive method from selection and during the study.
Current relevant disease.
Previous chronic processes or with rebound characteristics that could interfere with study according investigator's judgment.
Volunteers who have received pharmacological treatment, including medicinal plants, during the four weeks previous to beginning the study.
Having used corticoids sporadically in the last 30 days whichever the route aof administration, or any med by ocular or nasal administration route.
Case history of hypersensitivity to meds or any other allergic process.
Visual alterations: previous eye surgery, glaucoma, use of lenses, uveitis or ocular surface pathology (dry eye, blepharitis).
Volunteers with visual alteration with more than 3 dioptres in either eye.
Volunteers who has participated in a clinical trial during the past fout months before study entry.
Blood or derivate transfusion during the six previous months to study entry.
Case history of drug or alcohol abuse or dependence.
Positive result in test drug abuse during selection period.
positive serology results to hepatitis B virus(HbsAg), virus C o VIH.
Analytic alterations medically relevant, at investigator's judgement.