Back to resultsTolerance and Effect on Intraocular Pressure After Administration of SYL040012
Primary Purpose
Ocular Hypertension, Glaucoma
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
SYL040012
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Hypertension focused on measuring Ocular hypertension, Glaucoma, Beta-blocker
Eligibility Criteria
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.
Sites / Locations
- Clinica Universidad de Navarra
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SYL040012
Arm Description
Outcomes
Primary Outcome Measures
Part I: Local tolerance after administration of one dose of SYL040012.
Part II: Local tolerance after 7 days administration of SYL040012 with one dose per day.
Secondary Outcome Measures
Period I: Local Tolerance Assessment, Effect Assessment & Pharmacokinetic description after administration of one dose of SYL040012.Side effects. Analytics.
Period II:Tolerance assessment, Pharmacokinetic description, Effect assessment on the IOP after 7 days administration. Side effects. Analytics
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00990743
Brief Title
Tolerance and Effect on Intraocular Pressure After Administration of SYL040012
Official Title
Phase I Study With SYL040012. Tolerance and Effect on Intraocular Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sylentis, S.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether SYL040012 is safe for the treatment of ocular hypertension and glaucoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Glaucoma
Keywords
Ocular hypertension, Glaucoma, Beta-blocker
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SYL040012
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SYL040012
Intervention Description
Administration of single and multiple doses of SYL040012 in ophthalmic drops solution
Primary Outcome Measure Information:
Title
Part I: Local tolerance after administration of one dose of SYL040012.
Time Frame
Part I: 3 days
Title
Part II: Local tolerance after 7 days administration of SYL040012 with one dose per day.
Time Frame
Part II: 11 days
Secondary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Belen Sadaba, MD, PhD
Organizational Affiliation
Clínica Universitaria de Navarra
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Tolerance and Effect on Intraocular Pressure After Administration of SYL040012
We'll reach out to this number within 24 hrs