Overview

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

Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sylentis, S.A.
Treatments:
Ophthalmic Solutions
Tetrahydrozoline
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