Dose Finding Clinical Trial With SYL040012 to Evaluate the Tolerability and Effect on Intraocular Pressure in Subjects With Ocular Hypertension or Open Angle Glaucoma
Primary Purpose
Ocular Hypertension, Open Angle Glaucoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SYL040012
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Hypertension focused on measuring Glaucoma, Open Angle Glaucoma, Ocular Hypertension, IOP, RNAi, siRNA, beta inhibitor
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
Sites / Locations
- East Tallin Central Hospital
- Eye Clinic Dr. Krista Turman
- Universitaetsklinikum Freiburg
- Uniklinik Köln
- Universitaetsklinikum Mainz
- Clinica Universidad Navarra
- Institut Català de Retina
- Hospital Universitario Ramón y Cajal
- Hospital Universitario Clínico San Carlos
- Hospital Universitario 12 de Octubre
- Instituto de Oftalmobiología Aplicada
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
SYL040012 eye drops dose A
SYL040012 eye drops dose B
SYL040012 eye drops dose C
Placebo
Arm Description
Ocular topical administration of SYL040012 eye drops dose A
Ocular topical administration of SYL040012 eye drops dose B
Ocular topical administration of SYL040012 eye drops dose C
Ocular topical administration of placebo eye drops
Outcomes
Primary Outcome Measures
Difference in AUC between IOP Curve Obtained at the Established Time Points and the Same Curve Performed at Baseline Period
Simple Corneal and Conjunctival Evaluation
Secondary Outcome Measures
Visual acuity, anterior segment and ocular fundus examination as measures of local tolerability.
Physical exploration and laboratory tests as measurements of general tolerability
Assessment of Adverse Events Appearance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01739244
Brief Title
Dose Finding Clinical Trial With SYL040012 to Evaluate the Tolerability and Effect on Intraocular Pressure in Subjects With Ocular Hypertension or Open Angle Glaucoma
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sylentis, S.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Open Angle Glaucoma
Keywords
Glaucoma, Open Angle Glaucoma, Ocular Hypertension, IOP, RNAi, siRNA, beta inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SYL040012 eye drops dose A
Arm Type
Experimental
Arm Description
Ocular topical administration of SYL040012 eye drops dose A
Arm Title
SYL040012 eye drops dose B
Arm Type
Experimental
Arm Description
Ocular topical administration of SYL040012 eye drops dose B
Arm Title
SYL040012 eye drops dose C
Arm Type
Experimental
Arm Description
Ocular topical administration of SYL040012 eye drops dose C
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Ocular topical administration of placebo eye drops
Intervention Type
Drug
Intervention Name(s)
SYL040012
Intervention Description
Ocular topical administration of SYL040012 for 14 consecutive days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Ocular topical administration of placebo for 14 consecutive days
Primary Outcome Measure Information:
Title
Difference in AUC between IOP Curve Obtained at the Established Time Points and the Same Curve Performed at Baseline Period
Time Frame
14 days + (4-7 days)
Title
Simple Corneal and Conjunctival Evaluation
Time Frame
15 days + (3-6 days)
Secondary Outcome Measure Information:
Title
Visual acuity, anterior segment and ocular fundus examination as measures of local tolerability.
Time Frame
14 days + (4-7 days)
Title
Physical exploration and laboratory tests as measurements of general tolerability
Time Frame
14 days + (4-7 days)
Title
Assessment of Adverse Events Appearance
Time Frame
14 days + (4-7 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
East Tallin Central Hospital
City
Tallin
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Eye Clinic Dr. Krista Turman
City
Tallin
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Universitaetsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Uniklinik Köln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitaetsklinikum Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Clinica Universidad Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Institut Català de Retina
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Instituto de Oftalmobiología Aplicada
City
Valladolid
ZIP/Postal Code
47011
Country
Spain
12. IPD Sharing Statement
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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
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