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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01739244
• Other study ID #: SYL040012_III
• Status: Completed
• Phase: Phase 2
• First received: November 12, 2012
• Last updated: June 7, 2013
• Start date: July 2012
• Est. completion date: May 2013

Study information

• Verified date: June 2013
• Source: Sylentis, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of MedicinesSpain: Ethics CommitteeEstonia: Research Ethics CommitteeEstonia: The State Agency of MedicineGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open Angle Glaucoma

Intervention

Drug:
• SYL040012
Ocular topical administration of SYL040012 for 14 consecutive days
• Placebo
Ocular topical administration of placebo for 14 consecutive days

Locations

Country	Name	City	State
Estonia	East Tallin Central Hospital	Tallin
Estonia	Eye Clinic Dr. Krista Turman	Tallin
Germany	Universitaetsklinikum Freiburg	Freiburg
Germany	Uniklinik Köln	Köln
Germany	Universitaetsklinikum Mainz	Mainz
Spain	Institut Català de Retina	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Clínico San Carlos	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Clinica Universidad Navarra	Pamplona	Navarra
Spain	Instituto de Oftalmobiología Aplicada	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Sylentis, S.A.

Countries where clinical trial is conducted

Estonia,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	Simple Corneal and Conjunctival Evaluation		15 days + (3-6 days)	Yes
Secondary	Visual acuity, anterior segment and ocular fundus examination as measures of local tolerability.		14 days + (4-7 days)	Yes
Secondary	Physical exploration and laboratory tests as measurements of general tolerability		14 days + (4-7 days)	Yes
Secondary	Assessment of Adverse Events Appearance		14 days + (4-7 days)	Yes