Clinical trial NCT01739244: Dose Finding Clinical Trial With SYL040012 to Evaluate the Tolerability and Effect on Intraocular Pressure in Subjects With Ocular Hypertension or Open Angle Glaucoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ocular Hypertension
Open Angle Glaucoma
Keywords: Glaucoma
Open Angle Glaucoma
Ocular Hypertension
IOP
RNAi
siRNA
beta inhibitor
Lead sponsor: Sylentis, S.A.
Sponsor class: INDUSTRY
First posted: 2012-12-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Difference in AUC between IOP Curve Obtained at the Established Time Points and the Same Curve Performed at Baseline Period
timeFrame: 14 days + (4-7 days)
measure: Simple Corneal and Conjunctival Evaluation
timeFrame: 15 days + (3-6 days)
Secondary outcomes:
measure: Visual acuity, anterior segment and ocular fundus examination as measures of local tolerability.
timeFrame: 14 days + (4-7 days)
measure: Physical exploration and laboratory tests as measurements of general tolerability
timeFrame: 14 days + (4-7 days)
measure: Assessment of Adverse Events Appearance
timeFrame: 14 days + (4-7 days)
Other outcomes:
Locations:
city: Tallin
country: Estonia
facility: East Tallin Central Hospital
city: Tallin
country: Estonia
facility: Eye Clinic Dr. Krista Turman
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg
city: Köln
country: Germany
facility: Uniklinik Köln
city: Mainz
country: Germany
facility: Universitaetsklinikum Mainz
city: Pamplona
country: Spain
facility: Clinica Universidad Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Institut Català de Retina
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Valladolid
country: Spain
facility: Instituto de Oftalmobiología Aplicada
Study officials:
References: