NCT00990743

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 5, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

October 22, 2010

Status Verified

October 1, 2010

Enrollment Period

9 months

First QC Date

October 5, 2009

Last Update Submit

October 21, 2010

Conditions

Ocular HypertensionGlaucoma

Keywords

Ocular hypertensionGlaucomaBeta-blocker

Outcome Measures

Primary Outcomes (2)

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

    Part I: 3 days

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

    Part II: 11 days

Secondary Outcomes (2)

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

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

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

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

Study Arms (1)

SYL040012

EXPERIMENTAL
Drug: SYL040012

Interventions

SYL040012DRUG

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

SYL040012

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers, any gender
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Ocular HypertensionGlaucoma

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Belen Sadaba, MD, PhD

    ClĂ­nica Universitaria de Navarra

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 5, 2009

First Posted

October 7, 2009

Study Start

September 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

October 22, 2010

Record last verified: 2010-10

Locations

ES(1)