Ocular HypertensionPhase 1NCT00990743
Tolerance and Effect on Intraocular Pressure After Administration of SYL040012
A Phase 1 study testing SYL040012 in people with Ocular Hypertension and Glaucoma, run by Sylentis, S.A. at 1 site in Spain.
Trial summary
The purpose of this study is to determine whether SYL040012 is safe for the treatment of ocular hypertension and glaucoma. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Ocular Hypertension, Glaucoma
- What is being tested?
- SYL040012
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2009to Jun 2010
- Phase
- Phase 1
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers, any gender
- 18 to 45 years of age,
- Subjects must provide signed informed consent prior to participation in any study-related procedures
- Body Mass Index between 19,5 and 29 kg/m2
- IOP </= 21 mmHg in both eyes
- Have a BCVA (Best corrected visual acuity) of >/= 0.8 (20/25) (Snellen scale), or </= 0.1 (LogMar units)in both eyes
- Normal Fluorescein Clearance Test in both eyes
- Normal funduscopy in both eyes
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, haematological, renal, neoplastic, hepatopathy, gastrointestinal distress, hypertension, or infectious acute processes
- Previous chronic processes or with rebound characteristics that could interfere with study according to the investigator's judgment.
- Volunteers who have received pharmacological treatment, including medicinal plants, during the four weeks previous to beginning the study.
- Having used anti-cholinergics, betablockers and corticoids sporadically in the last 30 days whichever the route of administration, or any med by ocular or nasal administration route.
- Case history of hypersensitivity to meds or any other allergic process
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- Visual alterations: Previous eye surgery, glaucoma, uveitis or ocular surface pathology (dry eye, blepharitis).
- Volunteers with visual alteration with more than 3 dioptres in either eye
- Use of contact lenses
- Volunteer who has participated in a clinical trial during the past four months before study entry.
- Blood or derivate transfusion during the six previous months to study entry
- Case history of drug or alcohol abuse or dependence.
- Positive result in test drug abuse during selection period
- Positive serology results to hepatitis B virus (HbsAg), virus C or HIV
- Analytic alterations medically relevant, at investigator's judgement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study With SYL040012. Tolerance and Effect on Intraocular Pressure
The purpose of this study is to determine whether SYL040012 is safe for the treatment of ocular hypertension and glaucoma.
- Conditions
- Ocular Hypertension, Glaucoma
- Being tested
- SYL040012
- Keywords
- Ocular hypertension, Glaucoma, Beta-blocker
- Medical subject headings
- Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYL040012Drug
Administration of single and multiple doses of SYL040012 in ophthalmic drops solution
| Study group | Role | What they receive |
|---|---|---|
| SYL040012 | Experimental | Not described Receives: Drug: SYL040012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part I: Local tolerance after administration of one dose of SYL040012.
Measured: Part I: 3 days
Part II: Local tolerance after 7 days administration of SYL040012 with one dose per day.
Measured: Part II: 11 days
Secondary outcomes (2)
Period I: Local Tolerance Assessment, Effect Assessment & Pharmacokinetic description after administration of one dose of SYL040012.Side effects. Analytics.
Measured: Part I: 1 hour, 1, 2, 3, days
Period II:Tolerance assessment, Pharmacokinetic description, Effect assessment on the IOP after 7 days administration. Side effects. Analytics
Measured: Part II: After each administration, at time 1 and 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2010
- Study completionJun 2010
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sylentis, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Belen Sadaba, MD, PhD, Principal investigator, Clínica Universitaria de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990743
- Sponsor's protocol ID
- 2008-008204-41
- Other IDs
- CUNFI-0511-0814, 2008
- Status last verified
- Oct 2010
- First submitted
- 5 Oct 2009
- Last updated
- 22 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study With SYL040012. Tolerance and Effect on Intraocular Pressure
- ClinicalTrials.gov ID
- NCT00990743
- Acronym / sponsor ID
- 2008-008204-41
- Conditions
- Ocular Hypertension, Glaucoma
- Keywords
- Ocular hypertension, Glaucoma, Beta-blocker
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sylentis, S.A.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 7 Oct 2009 (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 purpose of this study is to determine whether SYL040012 is safe for the treatment of ocular hypertension and glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SYL040012 | Experimental | Drug: SYL040012 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy volunteers, any gender
- 18 to 45 years of age,
- Subjects must provide signed informed consent prior to participation in any study-related procedures
- Body Mass Index between 19,5 and 29 kg/m2
- IOP </= 21 mmHg in both eyes
Key exclusion criteria (15 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, haematological, renal, neoplastic, hepatopathy, gastrointestinal distress, hypertension, or infectious acute processes
- Previous chronic processes or with rebound characteristics that could interfere with study according to the investigator's judgment.
- Volunteers who have received pharmacological treatment, including medicinal plants, during the four weeks previous to beginning the study.
- Having used anti-cholinergics, betablockers and corticoids sporadically in the last 30 days whichever the route of administration, or any med by ocular or nasal administration route.
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 |
|---|---|---|
| SYL040012Administration of single and multiple doses of SYL040012 in ophthalmic drops solution | Drug | SYL040012 |
Primary outcome
Part I: Local tolerance after administration of one dose of SYL040012.
Time frame: Part I: 3 days
Part II: Local tolerance after 7 days administration of SYL040012 with one dose per day.
Time frame: Part II: 11 days
2 secondary outcomes
Period I: Local Tolerance Assessment, Effect Assessment & Pharmacokinetic description after administration of one dose of SYL040012.Side effects. Analytics.
Time frame: Part I: 1 hour, 1, 2, 3, days
Period II:Tolerance assessment, Pharmacokinetic description, Effect assessment on the IOP after 7 days administration. Side effects. Analytics
Time frame: Part II: After each administration, at time 1 and 96 hours
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 22 Oct 2010.
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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.
Belen Sadaba, MD, PhD principal investigator
Clínica Universitaria de Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SYL040012 in people with Ocular Hypertension and Glaucoma, run by Sylentis, S.A. at 1 site 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 8 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 22 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
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?
Part I: Local tolerance after administration of one dose of SYL040012. (time frame: Part I: 3 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 22 Oct 2010.