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

NCT01739244 | Completed Phase 2

• 1 other identifier: SYL040012_III
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 9

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.

Conditions

Ocular Hypertension; Open Angle Glaucoma

Keywords

Glaucoma; Open Angle Glaucoma; Ocular Hypertension; IOP; RNAi; siRNA; beta inhibitor

Outcome Measures

Primary Outcomes (2)

• Difference in AUC between IOP Curve Obtained at the Established Time Points and the Same Curve Performed at Baseline Period

  14 days + (4-7 days)

• Simple Corneal and Conjunctival Evaluation

  15 days + (3-6 days)

Secondary Outcomes (3)

• Visual acuity, anterior segment and ocular fundus examination as measures of local tolerability.

  14 days + (4-7 days)

• Physical exploration and laboratory tests as measurements of general tolerability

  14 days + (4-7 days)

• Assessment of Adverse Events Appearance

  14 days + (4-7 days)

Study Arms (4)

SYL040012 eye drops dose A

EXPERIMENTAL

Ocular topical administration of SYL040012 eye drops dose A

Drug: SYL040012

SYL040012 eye drops dose B

EXPERIMENTAL

Ocular topical administration of SYL040012 eye drops dose B

Drug: SYL040012

SYL040012 eye drops dose C

EXPERIMENTAL

Ocular topical administration of SYL040012 eye drops dose C

Drug: SYL040012

Placebo

PLACEBO COMPARATOR

Ocular topical administration of placebo eye drops

Drug: Placebo

Interventions

SYL040012 DRUG

Ocular topical administration of SYL040012 for 14 consecutive days

SYL040012 eye drops dose A; SYL040012 eye drops dose B; SYL040012 eye drops dose C

Placebo DRUG

Ocular topical administration of placebo for 14 consecutive days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sylentis, S.A.: lead

Study Sites (11)

East Tallin Central Hospital

Tallinn, 10138, Estonia

Location

Eye Clinic Dr. Krista Turman

Tallinn, 13419, Estonia

Location

Uniklinik Köln

Cologne, 50937, Germany

Location

Universitaetsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Universitaetsklinikum Mainz

Mainz, 55131, Germany

Location

Hospital Universitario Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

Clinica Universidad Navarra

Pamplona, Navarre, 31008, Spain

Location

Institut Català de Retina

Barcelona, 08022, Spain

Location

Hospital Universitario Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Instituto de Oftalmobiología Aplicada

Valladolid, 47011, Spain

Location

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma, Open-Angle; Glaucoma

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2012
• First Posted: December 3, 2012
• Study Start: July 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 10, 2013

Record last verified: 2013-06

Locations

ES (6); DE (3)