Dose Finding Clinical Trial With SYL040012 to Evaluate the Tolerability and Effect on Intraocular Pressure in Subjects With Ocular Hypertension or Open Angle Glaucoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sylentis, S.A.
ClinicalTrials.gov Identifier:
NCT01739244
First received: November 12, 2012
Last updated: June 7, 2013
Last verified: June 2013
  Purpose

The aim of this dose-finding clinical trial is to evaluate the systemic tolerability, local tolerability and intraocular pressure lowering effect of three different doses of SYL040012 in subjects with ocular hypertension or open-angle glaucoma.


Condition Intervention Phase
Ocular Hypertension
Open Angle Glaucoma
Drug: SYL040012
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dose Finding Clinical Trial With SYL040012 to Evaluate the Tolerability and Effect on Intraocular Pressure in Subjects With Ocular Hypertension or Open Angle Glaucoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Difference in AUC between IOP Curve Obtained at the Established Time Points and the Same Curve Performed at Baseline Period [ Time Frame: 14 days + (4-7 days) ] [ Designated as safety issue: No ]
  • Simple Corneal and Conjunctival Evaluation [ Time Frame: 15 days + (3-6 days) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Visual acuity, anterior segment and ocular fundus examination as measures of local tolerability. [ Time Frame: 14 days + (4-7 days) ] [ Designated as safety issue: Yes ]
  • Physical exploration and laboratory tests as measurements of general tolerability [ Time Frame: 14 days + (4-7 days) ] [ Designated as safety issue: Yes ]
  • Assessment of Adverse Events Appearance [ Time Frame: 14 days + (4-7 days) ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: July 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SYL040012 eye drops dose A
Ocular topical administration of SYL040012 eye drops dose A
Drug: SYL040012
Ocular topical administration of SYL040012 for 14 consecutive days
Experimental: SYL040012 eye drops dose B
Ocular topical administration of SYL040012 eye drops dose B
Drug: SYL040012
Ocular topical administration of SYL040012 for 14 consecutive days
Experimental: SYL040012 eye drops dose C
Ocular topical administration of SYL040012 eye drops dose C
Drug: SYL040012
Ocular topical administration of SYL040012 for 14 consecutive days
Placebo Comparator: Placebo
Ocular topical administration of placebo eye drops
Drug: Placebo
Ocular topical administration of placebo for 14 consecutive days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must provide signed informed consent prior to participation in any study-related procedures.
  • Male and female subjects in good or fair general health as assessed by the investigator.
  • ≥18 years of age.
  • Previous history or newly diagnosed elevated IOP (≥21 mmHg) with or without open-angle glaucoma in both eyes.
  • Normal result, or result typical for open-angle glaucoma of the following assessments in both eyes or available results in writing within the last 3 months prior to baseline period i.e. up to 4 months before Day 1, on condition that no new ocular signs or symptoms (e.g. marked deterioration of vision, eye pain) has occurred since then which would justify a repeat examination:
  • Visual field 24-2 or equivalent
  • Optical coherence tomography (OCT)
  • Best corrected visual acuity ≥0.5 (20/40) on the Snellen chart, or ≤ 0.3 logMAR
  • Schirmer test (lacrimation)
  • 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.
  • Females of childbearing potential not willing to use a medically acceptable contraceptive method from enrolment until after the follow-up visit.
  • Any current disease or condition that might compromise the respiratory, cardiovascular, endocrine, neurological, haematological, renal, or gastrointestinal function.
  • Previous chronic processes or with rebound characteristics that could interfere with the study according to the investigator's judgment.
  • Body temperature.
  • Intolerability of any components of SYL040012 or placebo.
  • Unable to comply with the clinical trial requirements as judged by the investigator.
  • Beta blockers or corticosteroids use (other than cutaneous or intra-articular) for the treatment of concurrent diseases, even if sporadically, or any ocular or nasal vasoconstrictor treatment in the last 15 days prior to the first investigational product administration
  • Previous refractive surgery; cataract extraction in the last 6 months
  • Previous surgery for glaucoma.
  • Participation in a clinical trial within 2 months before the enrolment visit
  • Use of any other investigational product within 60 days before the enrolment visit.
  • Other drugs for the treatment of concurrent diseases are allowed. However, their dosages should be kept constant throughout the study.
  • Use of contact lenses in the last 7 days prior to the first investigational product administration and wearing contact lenses throughout the trial
  • History of ocular infection or inflammation within the last 3 months before the enrolment visit
  • Angle-closure or pigmentary glaucoma.
  • Chronic or current acute eye diseases such as scleritis, uveitis, blepharitis, conjunctivitis, or ocular Herpes simplex virus infection
  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: NCT01739244

Locations
Estonia
East Tallin Central Hospital
Tallin, Estonia, 10138
Eye Clinic Dr. Krista Turman
Tallin, Estonia, 13419
Germany
Universitaetsklinikum Freiburg
Freiburg, Germany, 79106
Uniklinik Köln
Köln, Germany, 50937
Universitaetsklinikum Mainz
Mainz, Germany, 55131
Spain
Clinica Universidad Navarra
Pamplona, Navarra, Spain, 31008
Institut Català de Retina
Barcelona, Spain, 08022
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Hospital Universitario Clínico San Carlos
Madrid, Spain, 28040
Instituto de Oftalmobiología Aplicada
Valladolid, Spain, 47011
Sponsors and Collaborators
Sylentis, S.A.
  More Information

No publications provided

Responsible Party: Sylentis, S.A.
ClinicalTrials.gov Identifier: NCT01739244     History of Changes
Other Study ID Numbers: SYL040012_III
Study First Received: November 12, 2012
Last Updated: June 7, 2013
Health Authority: Spain: Spanish Agency of Medicines
Spain: Ethics Committee
Estonia: Research Ethics Committee
Estonia: The State Agency of Medicine
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Sylentis, S.A.:
Glaucoma
Open Angle Glaucoma
Ocular Hypertension
IOP
RNAi
siRNA
beta inhibitor

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 18, 2014