Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy Volunteers

Dry Eye Clinical Trial

Official title:

Phase I Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01438281
• Other study ID #: SYL1001_I
• Secondary ID: 2010-023113-56
• Status: Completed
• Phase: Phase 1
• First received: September 14, 2011
• Last updated: July 16, 2012
• Start date: July 2011
• Est. completion date: June 2012

Study information

• Verified date: July 2012
• Source: Sylentis, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye
• Eye Pain
• Ocular Pain

Intervention

Drug:
• SYL1001
SYL1001 eye drops. topical administration

Locations

Country	Name	City	State
Spain	Clinica Universidad de Navarra	Pamplona	Navarra

Sponsors (1)

Lead Sponsor	Collaborator
Sylentis, S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	Period I: 3 days, Period II: 11 days	Yes
Secondary	General tolerance assessment after administration of one dose of SYL1001 (period 1) and after 7 days administration (period 2)	Corneal pachymetry eye exploration BCVA (best corrected visual acuity) eye fundus evaluation Clinical exploration Side effects	Period I: 3 days; Period II: 11 days	Yes