Skip to main content
OpenTrials
Completed

NCT Number: NCT00990743

Tolerance and Effect on Intraocular Pressure After Administration of SYL040012

The purpose of this study is to determine whether SYL040012 is safe for the treatment of ocular hypertension and glaucoma.

Completed

Looking for future studies?

Notify Me

Key information

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

  • Healthy volunteers, any gender
  • 18 to 45 years of age,
  • Subjects must provide signed informed consent prior to participation in any study-related procedures
  • Body Mass Index between 19,5 and 29 kg/m2
  • IOP </= 21 mmHg in both eyes
  • Have a BCVA (Best corrected visual acuity) of >/= 0.8 (20/25) (Snellen scale), or </= 0.1 (LogMar units)in both eyes
  • 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. Females of childbearing potential who will not use a medically acceptable contraceptive method from selection and during the hole study.
  • Current relevant disease, including respiratory disease, cardiovascular, endocrine, neurological, haematological, renal, neoplastic, hepatopathy, gastrointestinal distress, hypertension, or infectious acute processes
  • Previous chronic processes or with rebound characteristics that could interfere with study according to the investigator's judgment.
  • Volunteers who have received pharmacological treatment, including medicinal plants, during the four weeks previous to beginning the study.
  • Having used anti-cholinergics, betablockers and corticoids sporadically in the last 30 days whichever the route of 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, uveitis or ocular surface pathology (dry eye, blepharitis).
  • Volunteers with visual alteration with more than 3 dioptres in either eye
  • Use of contact lenses
  • Volunteer who has participated in a clinical trial during the past four 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 or HIV
  • Analytic alterations medically relevant, at investigator's judgement.

Treatment and study plan

SYL040012

Drug

Administration of single and multiple doses of SYL040012 in ophthalmic drops solution

Primary outcomes

  1. Part I: Local tolerance after administration of one dose of SYL040012.

    Time frame: Part I: 3 days

  2. Part II: Local tolerance after 7 days administration of SYL040012 with one dose per day.

    Time frame: Part II: 11 days

Secondary outcomes

  1. Period I: Local Tolerance Assessment, Effect Assessment & Pharmacokinetic description after administration of one dose of SYL040012.Side effects. Analytics.

    Time frame: Part I: 1 hour, 1, 2, 3, days

  2. Period II:Tolerance assessment, Pharmacokinetic description, Effect assessment on the IOP after 7 days administration. Side effects. Analytics

    Time frame: Part II: After each administration, at time 1 and 96 hours

Sponsors and collaborators

Lead sponsor

Sylentis, S.A.

Industry

Registry information

Official study title

Phase I Study With SYL040012. Tolerance and Effect on Intraocular Pressure

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 7, 2009
Registry last updated
Oct 22, 2010

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.

Published trials that share one or more normalized conditions with this study.