Ocular HypertensionPhase 2NCT01739244
Dose Finding Clinical Trial With SYL040012 to Evaluate the Tolerability and Effect on Intraocular Pressure in Subjects With Ocular Hypertension or Open Angle Glaucoma
A Phase 2 study testing SYL040012 in people with Ocular Hypertension and Open Angle Glaucoma, run by Sylentis, S.A. at 11 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Hypertension, Open Angle Glaucoma
- What is being tested?
- SYL040012
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 11 sitesin 3 countries
- Study dates
- Jul 2012to May 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Optical coherence tomography (OCT)
- Best corrected visual acuity ≥0.5 (20/40) on the Snellen chart, or ≤ 0.3 logMAR
- Schirmer test (lacrimation)
- Funduscopy
Who cannot join
- 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.
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- 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
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
Spain6 sites
Institut Català de Retina
Barcelona, 08022
Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034
Hospital Universitario Clínico San Carlos
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Clinica Universidad Navarra
Pamplona, Navarre, 31008
Instituto de Oftalmobiología Aplicada
Valladolid, 47011
Germany3 sites
Uniklinik Köln
Cologne, 50937
Universitaetsklinikum Freiburg
Freiburg im Breisgau, 79106
Universitaetsklinikum Mainz
Mainz, 55131
Estonia2 sites
East Tallin Central Hospital
Tallinn, 10138
Eye Clinic Dr. Krista Turman
Tallinn, 13419
About this study
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
- Being tested
- SYL040012, Placebo
- Keywords
- Glaucoma, Open Angle Glaucoma, Ocular Hypertension, IOP, RNAi, siRNA, beta inhibitor
- Medical subject headings
- Ocular Hypertension, Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYL040012Drug
Ocular topical administration of SYL040012 for 14 consecutive days
PlaceboDrug
Ocular topical administration of placebo for 14 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| SYL040012 eye drops dose A | Experimental | Ocular topical administration of SYL040012 eye drops dose A Receives: Drug: SYL040012 |
| SYL040012 eye drops dose B | Experimental | Ocular topical administration of SYL040012 eye drops dose B Receives: Drug: SYL040012 |
| SYL040012 eye drops dose C | Experimental | Ocular topical administration of SYL040012 eye drops dose C Receives: Drug: SYL040012 |
| Placebo | Placebo comparator | Ocular topical administration of placebo eye drops Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in AUC between IOP Curve Obtained at the Established Time Points and the Same Curve Performed at Baseline Period
Measured: 14 days + (4-7 days)
Simple Corneal and Conjunctival Evaluation
Measured: 15 days + (3-6 days)
Secondary outcomes (3)
Visual acuity, anterior segment and ocular fundus examination as measures of local tolerability.
Measured: 14 days + (4-7 days)
Physical exploration and laboratory tests as measurements of general tolerability
Measured: 14 days + (4-7 days)
Assessment of Adverse Events Appearance
Measured: 14 days + (4-7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2012 (estimated)
- Study startJul 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sylentis, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739244
- Sponsor's protocol ID
- SYL040012_III
- Status last verified
- Jun 2013
- First submitted
- 12 Nov 2012
- Last updated
- 10 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01739244
- Acronym / sponsor ID
- SYL040012_III
- Conditions
- Ocular Hypertension, Open Angle Glaucoma
- Keywords
- Glaucoma, Open Angle Glaucoma, Ocular Hypertension, IOP, RNAi, siRNA, beta inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sylentis, S.A.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 3 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SYL040012 eye drops dose A | Experimental | Drug: SYL040012Ocular topical administration of SYL040012 eye drops dose A |
| SYL040012 eye drops dose B | Experimental | Drug: SYL040012Ocular topical administration of SYL040012 eye drops dose B |
| SYL040012 eye drops dose C | Experimental | Drug: SYL040012Ocular topical administration of SYL040012 eye drops dose C |
| Placebo | Placebo comparator | Drug: PlaceboOcular topical administration of placebo eye drops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYL040012Ocular topical administration of SYL040012 for 14 consecutive days | Drug | SYL040012 eye drops dose A, SYL040012 eye drops dose B, SYL040012 eye drops dose C |
| PlaceboOcular topical administration of placebo for 14 consecutive days | Drug | Placebo |
Primary outcome
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)
Simple Corneal and Conjunctival Evaluation
Time frame: 15 days + (3-6 days)
3 secondary outcomes
Visual acuity, anterior segment and ocular fundus examination as measures of local tolerability.
Time frame: 14 days + (4-7 days)
Physical exploration and laboratory tests as measurements of general tolerability
Time frame: 14 days + (4-7 days)
Assessment of Adverse Events Appearance
Time frame: 14 days + (4-7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SYL040012 in people with Ocular Hypertension and Open Angle Glaucoma, run by Sylentis, S.A. at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain, Germany, Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2013.