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

Phase 2

Completed

• Conditions: Ocular Hypertension; Open Angle Glaucoma
• Interventions: Drug: SYL040012; Drug: Placebo

• Registration Number: NCT01739244
• Lead Sponsor: Sylentis, S.A.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-11-12
• Study First Submitted QC: 2012-11-28
• Study First Posted: 2012-12-03
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-07
• Last Update Posted: 2013-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SYL040012 eye drops dose A	SYL040012	Ocular topical administration of SYL040012 eye drops dose A
SYL040012 eye drops dose B	SYL040012	Ocular topical administration of SYL040012 eye drops dose B
SYL040012 eye drops dose C	SYL040012	Ocular topical administration of SYL040012 eye drops dose C
Placebo	Placebo	Ocular topical administration of placebo eye drops

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (11)

Institut Català de Retina; 🇪🇸 Barcelona, Spain

Clinica Universidad Navarra; 🇪🇸 Pamplona, Navarra, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Uniklinik Köln; 🇩🇪 Köln, Germany

East Tallin Central Hospital; 🇪🇪 Tallin, Estonia

Instituto de Oftalmobiología Aplicada; 🇪🇸 Valladolid, Spain

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Universitaetsklinikum Mainz; 🇩🇪 Mainz, Germany

Universitaetsklinikum Freiburg; 🇩🇪 Freiburg, Germany

Hospital Universitario Clínico San Carlos; 🇪🇸 Madrid, Spain

Eye Clinic Dr. Krista Turman; 🇪🇪 Tallin, Estonia