Dose Finding Clinical Trial with SYL040012 in subjects with ocular hypertensio

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 84

Inclusion Criteria

1.Signed informed consent prior to any clinical trial-related procedures.
2.Male and female subjects in good or fair general health as assessed by the investigator.
3.Age ?18 years.
4.Previous history or newly diagnosed IOP (?21 mmHg) with or without open-angle glaucoma in both eyes.
5.Normal result, or result typical for open-angle glaucoma of the following assessments in both eyes or available results in writting 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 (24-2 Humphrey visual field SITA test, about 5 minutes per eye).
-Optical coherence tomography (OCT).
-Best corrected visual acuity ?0.5 (20/40) on the Snellen chart, or ?0.3 logMAR.
-Schirmer test (lacrimation).
-Funduscopy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Exclusion criteria related to general health
1.Pregnant or breastfeeding females or females with a positive urine pregnancy test at the baseline period and on Day 1 of the treatment period.
2.Females of childbearing potential not willing to use a medically acceptable contraceptive method from enrolment until after the follow-up visit.
?Females of childbearing potential are defined as females who are not post menopausal (amenorrheic without an alternative medical cause) or have not been irreversibly surgical sterilised by hysterectomy, bilateral oophorectomy or bilateral salpingectomy.
?Medically acceptable contraceptive methods include vasectomised sexual partner, tubal occlusion, intrauterine device (copper banded coils only), intrauterine system (for example, Mirena), Depo-Provera, implants (Implanon, Norplan), normal and low dose combined oral pills, ethinylestradiol transdermal system (Evra Patch), and intravaginal device (NuvaRing). True sexual abstinence (starting from enrolment until after the follow-up visit) is also an acceptable contraceptive method.
3.Any current disease or condition that might compromise the respiratory, cardiovascular, endocrine, neurological, haematological, renal, or gastrointestinal function (unless deemed not clinically significant by the investigator and sponsor) such as, but not limited to, uncontrolled arterial hypertension (defined as systolic blood pressure [SBP] >160 mmHg or diastolic blood pressure [DBP] >95 mmHg with or without treatment), acute infection in any of the above mentioned systems, uncontrolled type 1 or type 2 diabetes (defined as persistently varying glucose values, receiving multiple insulin injections per day), bronchial asthma requiring frequent use of corticosteroids, or heart failure (New York Heart Association [NYHA] ?grade 2).
4.Past history of a chronic or recurring condition that could interfere with treatment according to the investigator?s judgement. History of cancer in the last 5 years (except for cutaneous basal or squamous cell carcinoma resolved by excision).
5.Body temperature (axillary, oral or external auditory canal) ?37.5°C (only to be checked at the enrolment visit).
6.Intolerability of any components of SYL040012 or placebo.
7.Unable to comply with the clinical trial requirements as judged by the investigator.

Exclusion criteria related to medications or procedures
8.Beta blockers or corticosteroids (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
9.Previous refractive surgery; cataract extraction in the last 6 months.
10.Previous surgery for glaucoma.
11.Participation in a clinical trial within 2 months before the enrolment visit.
12.Use of any other investigational product within 60 days before the enrolment visit.
13.Other drugs for the treatment of concurrent diseases are allowed. However, their dosages should be kept constant throughout the study.

Exclusion criteria related to ocular conditions
14. Use of contact lenses in the last 7 days prior to the first investigational product administration and wearing contact lenses throughout the trial.
15.History of ocular infection or inflammation within the last 3 months before the enrolment visit.
16.Pachymetry result (in the middle of the cornea) >620 micron or <500 micron.
17.Angle-closure or pigmentary

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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