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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ocular Hypertension, Open Angle Glaucoma

Intervention / Treatment
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* Drug: SYL040012
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SYL040012 eye drops dose A<br>Ocular topical administration of SYL040012 eye drops dose A | Drug: SYL040012<br>* Ocular topical administration of SYL040012 for 14 consecutive days<br>|
| Experimental: SYL040012 eye drops dose B<br>Ocular topical administration of SYL040012 eye drops dose B | Drug: SYL040012<br>* Ocular topical administration of SYL040012 for 14 consecutive days<br>|
| Experimental: SYL040012 eye drops dose C<br>Ocular topical administration of SYL040012 eye drops dose C | Drug: SYL040012<br>* Ocular topical administration of SYL040012 for 14 consecutive days<br>|
| Placebo Comparator: Placebo<br>Ocular topical administration of placebo eye drops | Drug: Placebo<br>* Ocular topical administration of placebo for 14 consecutive days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, Open Angle Glaucoma, Ocular Hypertension, IOP, RNAi, siRNA, beta inhibitor