Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy Volunteers

Phase 1

Completed

• Conditions: Ocular Pain; Dry Eye
• Interventions: Drug: SYL1001

• Registration Number: NCT01438281
• Lead Sponsor: Sylentis, S.A.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-09-14
• Study First Submitted QC: 2011-09-21
• Study First Posted: 2011-09-22
• Primary Completion: 2011-11
• Study Completion: 2012-06
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-16
• Last Update Posted: 2012-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SYL1001	SYL1001	-

Primary Outcome Measures

Name	Time	Method
Local tolerance assessment of cornea and conjunctival sac after administration of one dose of SYL1001 for period 1 and after 7 days of administration of SYL1001 with one dose per day for period 2.	Period I: 3 days, Period II: 11 days	Local tolerance and ocular surface (cornea and conjunctival) on the area of administration 24 hours after last 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 in cases where asubjects refers them

Secondary Outcome Measures

Name	Time	Method
General tolerance assessment after administration of one dose of SYL1001 (period 1) and after 7 days administration (period 2)	Period I: 3 days; Period II: 11 days	Corneal pachymetry eye exploration BCVA (best corrected visual acuity) eye fundus evaluation Clinical exploration Side effects

Trial Locations

Locations (1)

Clinica Universidad de Navarra; 🇪🇸 Pamplona, Navarra, Spain