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

NCT ID: NCT01739244

Last Updated: 2013-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SYL040012 eye drops dose A

Ocular topical administration of SYL040012 eye drops dose A

Group Type: EXPERIMENTAL

SYL040012

Intervention Type: DRUG

Ocular topical administration of SYL040012 for 14 consecutive days

SYL040012 eye drops dose B

Ocular topical administration of SYL040012 eye drops dose B

Group Type: EXPERIMENTAL

SYL040012

Intervention Type: DRUG

Ocular topical administration of SYL040012 for 14 consecutive days

SYL040012 eye drops dose C

Ocular topical administration of SYL040012 eye drops dose C

Group Type: EXPERIMENTAL

SYL040012

Intervention Type: DRUG

Ocular topical administration of SYL040012 for 14 consecutive days

Placebo

Ocular topical administration of placebo eye drops

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Ocular topical administration of placebo for 14 consecutive days

Interventions

SYL040012

Ocular topical administration of SYL040012 for 14 consecutive days

Intervention Type: DRUG

Placebo

Ocular topical administration of placebo for 14 consecutive days

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sylentis, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

East Tallin Central Hospital

Tallinn, , Estonia

Eye Clinic Dr. Krista Turman

Tallinn, , Estonia

Uniklinik Köln

Cologne, , Germany

Universitaetsklinikum Freiburg

Freiburg im Breisgau, , Germany

Universitaetsklinikum Mainz

Mainz, , Germany

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Spain

Clinica Universidad Navarra

Pamplona, Navarre, Spain

Institut Català de Retina

Barcelona, , Spain

Hospital Universitario Clínico San Carlos

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Instituto de Oftalmobiología Aplicada

Valladolid, , Spain

Countries

Estonia; Germany; Spain

Other Identifiers

SYL040012_III

Identifier Type: -

Identifier Source: org_study_id