Open Angle GlaucomaPhase 2SYLTAGNCT02250612
SYL040012, Treatment for Open Angle Glaucoma
A Phase 2 study testing 1 drop of 0.375% SYL040012 (bamosiran), 1 drop of 0.750% SYL040012 (bamosiran) and 1 drop of 1.125% SYL040012 (bamosiran) in people with Open Angle Glaucoma and Ocular Hypertension, run by Sylentis, S.A. at 21 sites in 4 countries.
Trial summary
The purpose of this double-masked, randomized, controlled study is to assess the safety and ocular hypotensive efficacy of four different doses of SYL040012 (bamosiran) eye drops compared to Timolol maleate 0.5% after 28 treatment days in patients with elevated intraocular pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- 1 drop of 0.375% SYL040012 (bamosiran), 1 drop of 0.750% SYL040012 (bamosiran) and 1 drop of 1.125% SYL040012 (bamosiran)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 21 sitesin 4 countries
- Study dates
- Oct 2014to Jan 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients older than 18 years of either sex
- Good or fair general health as assessed by the investigator.
- Signed informed consent prior to any clinical trial-related procedures
- Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT)
- Post-washout mean IOP above target range
- BCVA 1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200)
Show all 9Show fewer
- Stable visual field
- Central corneal thickness 480-620 μm
- Shaffer gonioscopic grade of ≥ 3 (in at least 3 quadrants) in both eyes
Who cannot join
- Pregnant or breastfeeding females
- Females of childbearing potential not willing to use a medically acceptable contraceptive method
- Clinically significant systemic disease
- Changes of systemic medication that could have a substantial effect on IOP
- Known hypersensitivity to any component of the formulations
- Unable to comply with the clinical trial requirements
Show all 15Show fewer
- Clinically significant abnormalities in laboratory tests
- Severe visual field defect
- Any secondary glaucoma
- Pseudoexfoliation or pigment dispersion component, history of angle closure or narrow angles.
- IOP ≥ 35 mm Hg in any eye
- Previous non-laser glaucoma surgery or glaucoma laser procedures (e.g., laser trabeculoplasty) and refractive surgery
- Any ocular surgery or laser treatment, cataract extraction or ocular trauma within 6 months prior to Baseline
- Evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at baseline (Visit 0), or a history of herpes simplex keratitis
- Clinically significant ocular disease
Trial locations and contacts
21 sites in 4 countries.
21 sites in 4 countries
Spain9 sites
Hospital Clinic
Barcelona, 08036
Hospital de Jerez
Jerez de la Frontera, Cádiz, 11407
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Universitario Clínico San Carlos
Madrid, 28040
Clinica Universidad Navarra
Pamplona, Navarre, 31008
Complejo Hospitalario de Pontevedra
Pontevedra, 36001
Hospital de Torrevieja
Torrevieja, Alicante, 03186
Instituto de Oftalmobiología Aplicada
Valladolid, 47011
Hospital Universitario Miguel Servet
Zaragoza, 50009
Germany5 sites
Universitaetsklinikum Freiburg
Freiburg im Breisgau, 79106
University Clinic Magdeburg
Magdeburg, 39106
Klinikum der Universität München
München, 80336
Universitätsklinikum Münster
Münster, D-48149
University Hospital Regensburg
Regensburg, 93053
United States4 sites
Sall Research Medical Center
Artesia, California, 90701
Taustin Eye Center
Louisville, Kentucky, 40217
Eye Care Centers Management, Inc (Clayton Eye Center)
Morrow, Georgia, 30260
North Bay Eye Associates
Petaluma, California, 94954
Estonia3 sites
East Tallin Central Hospital
Tallinn, 10138
Eye Clinic Dr. Krista Turman
Tallinn, 13419
Tartu University Hospital
Tartu, 50406
About this study
Official title: A Phase II, Observer Masked, Active Controlled Study of SYL040012 for the Treatment of Elevated Intraocular Pressure in Patients With Open-angle Glaucoma or Ocular Hypertension
The purpose of this double-masked, randomized, controlled study is to assess the safety and ocular hypotensive efficacy of four different doses of SYL040012 (bamosiran) eye drops compared to Timolol maleate 0.5% after 28 treatment days in patients with elevated intraocular pressure.
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Being tested
- 1 drop of 0.375% SYL040012 (bamosiran), 1 drop of 0.750% SYL040012 (bamosiran), 1 drop of 1.125% SYL040012 (bamosiran), 1 drop of 1.5% SYL040012 (bamosiran), 1 drop of 0.5 % timolol maleate
- Keywords
- SYL040012, bamosiran, siRNA, RNAi, Glaucoma, Ocular hypertension
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 drop of 0.375% SYL040012 (bamosiran)Drug
1 drop of 0.750% SYL040012 (bamosiran)Drug
1 drop of 1.125% SYL040012 (bamosiran)Drug
1 drop of 1.5% SYL040012 (bamosiran)Drug
1 drop of 0.5 % timolol maleateDrug
| Study group | Role | What they receive |
|---|---|---|
| SYL040012 (bamosiran) 0.375% eye drops | Experimental | 1 drop in each eye once daily for 28 consecutive days Receives: Drug: 1 drop of 0.375% SYL040012 (bamosiran) |
| SYL040012 (bamosiran) 0.750% eye drops | Experimental | 1 drop in each eye once daily for 28 consecutive days Receives: Drug: 1 drop of 0.750% SYL040012 (bamosiran) |
| SYL040012 (bamosiran) 1.125% eye drops | Experimental | 1 drop in each eye once daily for 28 consecutive days Receives: Drug: 1 drop of 1.125% SYL040012 (bamosiran) |
| SYL040012 (bamosiran) 1.5% eye drops | Experimental | 1 drop in each eye once daily for 28 consecutive days Receives: Drug: 1 drop of 1.5% SYL040012 (bamosiran) |
| Timolol maleate 0.5% ophthalmic solution | Active comparator | 1 drop in each eye twice daily for 28 consecutive days Receives: Drug: 1 drop of 0.5 % timolol maleate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm
Measured: Baseline and Day 28
Secondary outcomes (2)
Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm
Measured: Baseline and Day 14
Change From Baseline in the Glaucoma Quality of Life Questionnaire (GQL-15) Scores Within Each Treatment Arm
The GQL-15 is a 15 item, 4-domain tool. GQL-15 scoring ranges from 0 to 75. Higher scores indicate poorer quality of life.
Measured: Baseline and Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Open Angle GlaucomaStudies 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
- 184 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
- NCT02250612
- Sponsor's protocol ID
- SYL040012_IV
- Other IDs
- 2013-002947-27
- Acronym
- SYLTAG
- Status last verified
- Dec 2020
- First submitted
- 5 Sep 2014
- Last updated
- 6 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Observer Masked, Active Controlled Study of SYL040012 for the Treatment of Elevated Intraocular Pressure in Patients With Open-angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT02250612
- Acronym / sponsor ID
- SYLTAG / SYL040012_IV
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Keywords
- SYL040012, bamosiran, siRNA, RNAi, Glaucoma, Ocular hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Sylentis, S.A.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 26 Sep 2014 (estimated)
- Results
- Posted 4 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this double-masked, randomized, controlled study is to assess the safety and ocular hypotensive efficacy of four different doses of SYL040012 (bamosiran) eye drops compared to Timolol maleate 0.5% after 28 treatment days in patients with elevated intraocular pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| SYL040012 (bamosiran) 0.375% eye drops | Experimental | Drug: 1 drop of 0.375% SYL040012 (bamosiran)1 drop in each eye once daily for 28 consecutive days |
| SYL040012 (bamosiran) 0.750% eye drops | Experimental | Drug: 1 drop of 0.750% SYL040012 (bamosiran)1 drop in each eye once daily for 28 consecutive days |
| SYL040012 (bamosiran) 1.125% eye drops | Experimental | Drug: 1 drop of 1.125% SYL040012 (bamosiran)1 drop in each eye once daily for 28 consecutive days |
| SYL040012 (bamosiran) 1.5% eye drops | Experimental | Drug: 1 drop of 1.5% SYL040012 (bamosiran)1 drop in each eye once daily for 28 consecutive days |
| Timolol maleate 0.5% ophthalmic solution | Active comparator | Drug: 1 drop of 0.5 % timolol maleate1 drop in each eye twice daily for 28 consecutive days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients older than 18 years of either sex
- Good or fair general health as assessed by the investigator.
- Signed informed consent prior to any clinical trial-related procedures
- Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT)
- Post-washout mean IOP above target range
Key exclusion criteria (15 listed)
- Pregnant or breastfeeding females
- Females of childbearing potential not willing to use a medically acceptable contraceptive method
- Clinically significant systemic disease
- Changes of systemic medication that could have a substantial effect on IOP
- Known hypersensitivity to any component of the formulations
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 |
|---|---|---|
| 1 drop of 0.375% SYL040012 (bamosiran) | Drug | SYL040012 (bamosiran) 0.375% eye drops |
| 1 drop of 0.750% SYL040012 (bamosiran) | Drug | SYL040012 (bamosiran) 0.750% eye drops |
| 1 drop of 1.125% SYL040012 (bamosiran) | Drug | SYL040012 (bamosiran) 1.125% eye drops |
| 1 drop of 1.5% SYL040012 (bamosiran) | Drug | SYL040012 (bamosiran) 1.5% eye drops |
| 1 drop of 0.5 % timolol maleate | Drug | Timolol maleate 0.5% ophthalmic solution |
Primary outcome
Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm
Time frame: Baseline and Day 28
2 secondary outcomes
Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm
Time frame: Baseline and Day 14
Change From Baseline in the Glaucoma Quality of Life Questionnaire (GQL-15) Scores Within Each Treatment Arm
Time frame: Baseline and Day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
21 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1 drop of 0.375% SYL040012 (bamosiran), 1 drop of 0.750% SYL040012 (bamosiran) and 1 drop of 1.125% SYL040012 (bamosiran) in people with Open Angle Glaucoma and Ocular Hypertension, run by Sylentis, S.A. at 21 sites in 4 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 9 inclusion and 15 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 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Spain, Germany, United States, 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. 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?
Yes. Results are posted in the registry (first posted 4 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm (time frame: Baseline and Day 28). 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 6 Jan 2021.