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Completed

NCT Number: NCT01438281

Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy Volunteers

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

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Key information

Conditions

Ocular Pain Dry Eye Dry Eye Syndromes Eye Diseases Eye Manifestations Eye Pain Lacrimal Apparatus Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SYL1001

Drug

SYL1001 eye drops. topical administration

Primary outcomes

  1. 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.

    Time frame: 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 outcomes

  1. General tolerance assessment after administration of one dose of SYL1001 (period 1) and after 7 days administration (period 2)

    Time frame: Period I: 3 days; Period II: 11 days

    Corneal pachymetry eye exploration BCVA (best corrected visual acuity) eye fundus evaluation Clinical exploration Side effects

Sponsors and collaborators

Lead sponsor

Sylentis, S.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Sep 22, 2011
Registry last updated
Jul 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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