GlaucomaPhase 1/2NCT01227291
SYL040012. Tolerance and Effect on Intraocular Pressure in Subjects With Intraocular Pressure (IOP) >= 21 mm Hg
A Phase 1/2 study testing SYL040012 in people with Glaucoma and Ocular Hypertension, run by Sylentis, S.A. at 2 sites in Spain.
Trial summary
The aim of this study is to evaluate the tolerance and effect on unmedicated subjects with elevated IOP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- SYL040012
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSpain
- Study dates
- Oct 2010to Sep 2012
- Phase
- Phase 1/2
- 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
- Both genders.
- >/= 18 years of age with elevated IOP with OAG diagnosis.
- Subjects must provide signed informed consent prior to participation in any study-related procedures
- IOP >/= 21 mmHg and < 30 mmHg in three different assessment days.
- Normal Ocular test (in both eyes):
- Visual field: 24-2 or equivalent
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- Normal OCT
- BCVA: >/= 0,5 (20/40) Snellen scale, or </=0.3 LogMar.
- Normal Schirmer Test .
- Normal 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.
- Current relevant disease, including respiratory disease, cardiovascular, endocrine, neurological, hematological, renal, neoplastic, hepatopathy, gastrointestinal distress, hypertension or infectious acute processes.
- Previous chronic processes or with rebound characteristics that could interfere with the study according to the investigator's judgment.
- Having used betablockers and corticoids sporadically in the last 15 days whichever the route of administration.
- Previous eye refractive surgery
- Subjects with visual alteration with more than 3 dioptres for hypermetropy and/or astigmatism.
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- Use of contact lenses during the last 7 days before starting the treatment.
- Subjects who has participated in a clinical trial during the past 2 months before study entry.
- Analytic alterations medically relevant, at investigator judgment.
- Positive results in test drug abuse during selection period.
- Subjects with at least 2 visual fields or fiber layer measured in two different days abnormals
- History of ocular infection or inflammation within the past 3 months
- Pachymetry(in the middle of the cornea) >600 microm or < 500 microm.
- Subjects with IOP associated to close angle glaucoma
- History of chronic or severe acute ocular disease (i.e. scleritis, uveitis, blepharitis, conjunctivitis or herpes simplex virus)
- History of intolerance to any of the components of the drug formulation
- Subjects with previous iridotomy with IOP related with close angle glaucoma.
- Previous ocular surgery in glaucoma
- Corneal refractive surgery (e.g., keratotomy, PRK, LASIK, etc)
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034
Clinica Universidad Navarra
Pamplona, Navarre, 31008
About this study
Official title: Study With SYL040012. Tolerance and Effect on Intraocular Pressure in Subjects With IOP >= 21 mm Hg.
The aim of this study is to evaluate the tolerance and effect on unmedicated subjects with elevated IOP.
Read the detailed description
The aim of this study is to evaluate the tolerance and effect on unmedicated subjects with elevated IOP. An unmedicated subject is considered a person without any IOP/glaucoma treatment at least one month before recruitment.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- SYL040012
- Keywords
- Glaucoma, IOP, siRNAs, RNAi, beta inhibitor
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYL040012Drug
Also called No additional names
SYL040012 ophthalmic drops, daily single dose administration
| Study group | Role | What they receive |
|---|---|---|
| SYL040012 | Experimental | SYL040012 Ophthalmic drop administration Receives: Drug: SYL040012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance on ocular surface (ocular and conjunctiva)
Local Tolerance and ocular surface(cornea and conjunctival) on the area of administration 24 hours after last administration of multiple dose during 7 days of administration. It will be performed using a slit lamp which will be performed before, during and after the administration at established times. Adverse events will be registered and the determination of subjective tolerance will use the visual analogical scale (VAS) in cases where a subjects refers them.
Measured: 7 days + 24 hours
Secondary outcomes (1)
Tolerance, Adverse events, Pharmacokinetics and effect
Local Tolerance on the area of administration at 1 hour and 96 hours after the last administered dose: corneal pachymetry, rest of anterior exploration of the eye, visual acuity, eye fundus, clinical exam (including physical exploration, vital signs, analytical blood and urine test, and ECG.
Other parameters: analytics, VAS evaluation, Evaluation of adverse event appearance Pharmacokinetics: SYL040012 blood absorption will be evaluated after topical ocular administration Effect on IOP
Measured: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sylentis, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Javier Moreno, MD, PhD, Principal investigator, Clinica Universidad de NavarraFrancisco Muñoz, MD, PhD, Principal investigator, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01227291
- Sponsor's protocol ID
- SYL040012_II
- Status last verified
- Sep 2012
- First submitted
- 21 Oct 2010
- Last updated
- 27 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study With SYL040012. Tolerance and Effect on Intraocular Pressure in Subjects With IOP >= 21 mm Hg.
- ClinicalTrials.gov ID
- NCT01227291
- Acronym / sponsor ID
- SYL040012_II
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- Glaucoma, IOP, siRNAs, RNAi, beta inhibitor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sylentis, S.A.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 25 Oct 2010 (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 study is to evaluate the tolerance and effect on unmedicated subjects with elevated IOP.
Detailed description
The aim of this study is to evaluate the tolerance and effect on unmedicated subjects with elevated IOP. An unmedicated subject is considered a person without any IOP/glaucoma treatment at least one month before recruitment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SYL040012 | Experimental | Drug: SYL040012SYL040012 Ophthalmic drop administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Both genders.
- >/= 18 years of age with elevated IOP with OAG diagnosis.
- Subjects must provide signed informed consent prior to participation in any study-related procedures
- IOP >/= 21 mmHg and < 30 mmHg in three different assessment days.
- Normal Ocular test (in both eyes):
Key exclusion criteria (19 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.
- Current relevant disease, including respiratory disease, cardiovascular, endocrine, neurological, hematological, renal, neoplastic, hepatopathy, gastrointestinal distress, hypertension or infectious acute processes.
- Previous chronic processes or with rebound characteristics that could interfere with the study according to the investigator's judgment.
- Having used betablockers and corticoids sporadically in the last 15 days whichever the route of administration.
- Previous eye refractive surgery
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 |
|---|---|---|
| SYL040012Also: No additional namesSYL040012 ophthalmic drops, daily single dose administration | Drug | SYL040012 |
Primary outcome
Tolerance on ocular surface (ocular and conjunctiva)
Time frame: 7 days + 24 hours
Local Tolerance and ocular surface(cornea and conjunctival) on the area of administration 24 hours after last administration of multiple dose during 7 days of administration. It will be performed using a slit lamp which will be performed before, during and after the administration at established times. Adverse events will be registered and the determination of subjective tolerance will use the visual analogical scale (VAS) in cases where a subjects refers them.
1 secondary outcome
Tolerance, Adverse events, Pharmacokinetics and effect
Time frame: 11 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 27 Sep 2012.
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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.
Javier Moreno, MD, PhD principal investigator
Clinica Universidad de Navarra
Francisco Muñoz, MD, PhD principal investigator
Hospital Universitario Ramon y Cajal
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SYL040012 in people with Glaucoma and Ocular Hypertension, run by Sylentis, S.A. at 2 sites in Spain.
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 19 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 27 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Tolerance on ocular surface (ocular and conjunctiva) (time frame: 7 days + 24 hours). 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 27 Sep 2012.