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SYL040012. Tolerance and Effect on Intraocular Pressure in Subjects With Intraocular Pressure (IOP) >= 21 mm Hg

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
SYL040012
Sponsored by
Sylentis, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, IOP, siRNAs, RNAi, beta inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Both genders.
  • >/= 18 years of age with elevated IOP with OAG diagnosis.
  • Subjects must provide signed informed consent prior to participation in any study-related procedures
  • IOP >/= 21 mmHg and < 30 mmHg in three different assessment days.

  • Normal Ocular test (in both eyes):

    • Visual field: 24-2 or equivalent
    • Normal OCT
    • BCVA: >/= 0,5 (20/40) Snellen scale, or </=0.3 LogMar.
    • Normal Schirmer Test .
    • Normal funduscopy.

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, hematological, renal, neoplastic, hepatopathy, gastrointestinal distress, hypertension or infectious acute processes.
  • Previous chronic processes or with rebound characteristics that could interfere with the study according to the investigator's judgment.
  • Having used betablockers and corticoids sporadically in the last 15 days whichever the route of administration.
  • Previous eye refractive surgery
  • Subjects with visual alteration with more than 3 dioptres for hypermetropy and/or astigmatism.
  • Use of contact lenses during the last 7 days before starting the treatment.
  • Subjects who has participated in a clinical trial during the past 2 months before study entry.
  • Analytic alterations medically relevant, at investigator judgment.
  • Positive results in test drug abuse during selection period.
  • Subjects with at least 2 visual fields or fiber layer measured in two different days abnormals
  • History of ocular infection or inflammation within the past 3 months
  • Pachymetry(in the middle of the cornea) >600 microm or < 500 microm.
  • Subjects with IOP associated to close angle glaucoma
  • History of chronic or severe acute ocular disease (i.e. scleritis, uveitis, blepharitis, conjunctivitis or herpes simplex virus)
  • History of intolerance to any of the components of the drug formulation
  • Subjects with previous iridotomy with IOP related with close angle glaucoma.
  • Previous ocular surgery in glaucoma
  • Corneal refractive surgery (e.g., keratotomy, PRK, LASIK, etc)

Sites / Locations

  • Clinica Universidad Navarra
  • Hospital Universitario Ramón y Cajal

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SYL040012

Arm Description

SYL040012 Ophthalmic drop administration

Outcomes

Primary Outcome Measures

Tolerance on ocular surface (ocular and conjunctiva)
Local Tolerance and ocular surface(cornea and conjunctival) on the area of administration 24 hours after last administration of multiple dose during 7 days of 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 (VAS) in cases where a subjects refers them.

Secondary Outcome Measures

Tolerance, Adverse events, Pharmacokinetics and effect
Local Tolerance on the area of administration at 1 hour and 96 hours after the last administered dose: corneal pachymetry, rest of anterior exploration of the eye, visual acuity, eye fundus, clinical exam (including physical exploration, vital signs, analytical blood and urine test, and ECG. Other parameters: analytics, VAS evaluation, Evaluation of adverse event appearance Pharmacokinetics: SYL040012 blood absorption will be evaluated after topical ocular administration Effect on IOP

Full Information

First Posted
October 21, 2010
Last Updated
September 26, 2012
Sponsor
Sylentis, S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01227291
Brief Title
SYL040012. Tolerance and Effect on Intraocular Pressure in Subjects With Intraocular Pressure (IOP) >= 21 mm Hg
Official Title
Study With SYL040012. Tolerance and Effect on Intraocular Pressure in Subjects With IOP >= 21 mm Hg.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sylentis, S.A.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to evaluate the tolerance and effect on unmedicated subjects with elevated IOP.
Detailed Description
The aim of this study is to evaluate the tolerance and effect on unmedicated subjects with elevated IOP. An unmedicated subject is considered a person without any IOP/glaucoma treatment at least one month before recruitment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension
Keywords
Glaucoma, IOP, siRNAs, RNAi, beta inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SYL040012
Arm Type
Experimental
Arm Description
SYL040012 Ophthalmic drop administration
Intervention Type
Drug
Intervention Name(s)
SYL040012
Other Intervention Name(s)
No additional names
Intervention Description
SYL040012 ophthalmic drops, daily single dose administration
Primary Outcome Measure Information:
Title
Tolerance on ocular surface (ocular and conjunctiva)
Description
Local Tolerance and ocular surface(cornea and conjunctival) on the area of administration 24 hours after last administration of multiple dose during 7 days of 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 (VAS) in cases where a subjects refers them.
Time Frame
7 days + 24 hours
Secondary Outcome Measure Information:
Title
Tolerance, Adverse events, Pharmacokinetics and effect
Description
Local Tolerance on the area of administration at 1 hour and 96 hours after the last administered dose: corneal pachymetry, rest of anterior exploration of the eye, visual acuity, eye fundus, clinical exam (including physical exploration, vital signs, analytical blood and urine test, and ECG. Other parameters: analytics, VAS evaluation, Evaluation of adverse event appearance Pharmacokinetics: SYL040012 blood absorption will be evaluated after topical ocular administration Effect on IOP
Time Frame
11 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both genders. >/= 18 years of age with elevated IOP with OAG diagnosis. Subjects must provide signed informed consent prior to participation in any study-related procedures IOP >/= 21 mmHg and < 30 mmHg in three different assessment days. Normal Ocular test (in both eyes): Visual field: 24-2 or equivalent Normal OCT BCVA: >/= 0,5 (20/40) Snellen scale, or </=0.3 LogMar. Normal Schirmer Test . Normal funduscopy. 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, hematological, renal, neoplastic, hepatopathy, gastrointestinal distress, hypertension or infectious acute processes. Previous chronic processes or with rebound characteristics that could interfere with the study according to the investigator's judgment. Having used betablockers and corticoids sporadically in the last 15 days whichever the route of administration. Previous eye refractive surgery Subjects with visual alteration with more than 3 dioptres for hypermetropy and/or astigmatism. Use of contact lenses during the last 7 days before starting the treatment. Subjects who has participated in a clinical trial during the past 2 months before study entry. Analytic alterations medically relevant, at investigator judgment. Positive results in test drug abuse during selection period. Subjects with at least 2 visual fields or fiber layer measured in two different days abnormals History of ocular infection or inflammation within the past 3 months Pachymetry(in the middle of the cornea) >600 microm or < 500 microm. Subjects with IOP associated to close angle glaucoma History of chronic or severe acute ocular disease (i.e. scleritis, uveitis, blepharitis, conjunctivitis or herpes simplex virus) History of intolerance to any of the components of the drug formulation Subjects with previous iridotomy with IOP related with close angle glaucoma. Previous ocular surgery in glaucoma Corneal refractive surgery (e.g., keratotomy, PRK, LASIK, etc)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Moreno, MD, PhD
Organizational Affiliation
Clinica Universidad de Navarra
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francisco Muñoz, MD, PhD
Organizational Affiliation
Hospital Universitario Ramon y Cajal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Universidad Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain

12. IPD Sharing Statement

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SYL040012. Tolerance and Effect on Intraocular Pressure in Subjects With Intraocular Pressure (IOP) >= 21 mm Hg

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