Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy Volunteers

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sylentis, S.A.

Criteria

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/=0,8 (20/25)Snellen scale, or
• 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.