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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sylentis, S.A.
ClinicalTrials.gov Identifier:
NCT01227291
First received: October 21, 2010
Last updated: September 26, 2012
Last verified: September 2012
  Purpose

The aim of this study is to evaluate the tolerance and effect on unmedicated subjects with elevated IOP.


Condition Intervention Phase
Glaucoma
Ocular Hypertension
Drug: SYL040012
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study With SYL040012. Tolerance and Effect on Intraocular Pressure in Subjects With IOP >= 21 mm Hg.

Resource links provided by NLM:


Further study details as provided by Sylentis, S.A.:

Primary Outcome Measures:
  • Tolerance on ocular surface (ocular and conjunctiva) [ Time Frame: 7 days + 24 hours ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]

    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



Enrollment: 30
Study Start Date: October 2010
Study Completion Date: September 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SYL040012
SYL040012 Ophthalmic drop administration
Drug: SYL040012
SYL040012 ophthalmic drops, daily single dose administration
Other Name: No additional names

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01227291

Locations
Spain
Clinica Universidad Navarra
Pamplona, Navarra, Spain, 31008
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Sponsors and Collaborators
Sylentis, S.A.
Investigators
Principal Investigator: Javier Moreno, MD, PhD Clinica Universidad de Navarra
Principal Investigator: Francisco Muñoz, MD, PhD Hospital Universitario Ramon y Cajal
  More Information

No publications provided

Responsible Party: Sylentis, S.A.
ClinicalTrials.gov Identifier: NCT01227291     History of Changes
Other Study ID Numbers: SYL040012_II
Study First Received: October 21, 2010
Last Updated: September 26, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Sylentis, S.A.:
Glaucoma
IOP
siRNAs
RNAi
beta inhibitor

Additional relevant MeSH terms:
Hypertension
Glaucoma
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 16, 2014