Ocular PainPhase 1/2NCT01776658
Pilot Study to Evaluate SYL1001 Safety and Effect in Patients With Ocular Pain
A Phase 1/2 study testing SYL1001 in people with Ocular Pain and Dry Eye Syndrome, run by Sylentis, S.A. at 3 sites in Spain.
Trial summary
The aim of this pilot study is to compare the analgesic effect of SYL1001 versus placebo in patients with ocular pain associated with Dry Eye Syndrome. General and local tolerability are also evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Pain, Dry Eye Syndrome
- What is being tested?
- SYL1001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesSpain
- Study dates
- Nov 2012to Apr 2015
- 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
- Patients of both genders
- Age ≥ 18 years old
- Give written informed consent to participate in the study after having been informed of the study design, objectives and possible derived risks
- Common mild to moderate dry eye symptoms. Persistent daily symptoms for more than three months:
- OSDI scale: 13-30
- VAS scale: 2-7
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- Ocular tests in both eyes:
- Corneal staining with fluorescein. Oxford scale > 0
- Tear Breakup Time Test: (BUT) < 10 seconds
- Schirmer test with anaesthesia < 10 mm/5min
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 whole study.
- Current relevant disease, including respiratory disease, cardiovascular, endocrine, neurological, haematological, renal, neoplasic, hepatopathy, gastrointestinal distress, hypertension, or infectious acute processes.
- Past history of a chronic o recurring condition that could interfere with study according to the investigator's judgement.
- Concomitant use of other drugs with analgesic activity by any route of administration at the enrolment period.
- Changes in any ocular and/or systemic concomitant medication one month prior to the study commencement and during the study development.
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- Changes on the preestablished artificial tears dosage 15 days prior to the study commencement and during the study development.
- Cyclosporine treatment initiation or changes in cyclosporine dosage or dosing regimen during the 6 months prior to enrolment.
- Previous history of drug hypersensitivity.
- Use of contact lenses
- Case history of drug or alcohol abuse or dependence.
- Relevant abnormal laboratory results as judged by the investigator
- Previous refractive surgery
- Participation in a clinical trial within 2 months before the enrolment visit
- Relevant ocular pathology judged by the investigator.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Fundación Jiménez Díaz
Madrid, 28040
Hospital Universitario Clínico San Carlos
Madrid, 28040
Instituto Oftalmológico Fernández-Vega
Oviedo, 33012
About this study
The aim of this pilot study is to compare the analgesic effect of SYL1001 versus placebo in patients with ocular pain associated with Dry Eye Syndrome. General and local tolerability are also evaluated.
- Conditions
- Ocular Pain, Dry Eye Syndrome
- Being tested
- SYL1001, Placebo
- Keywords
- Ocular pain, Dry Eye Syndrome, siRNA, RNAi, TRPV1
- Medical subject headings
- Eye Pain, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYL1001Drug
Ocular topical administration of SYL1001 for 10 consecutive days
PlaceboDrug
Ocular topical administration of placebo for 10 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| SYL1001 eye drops dose A | Experimental | Ocular topical administration of SYL1001 eye drops dose A Receives: Drug: SYL1001 |
| 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.
Changes from Baseline in the Ocular Pain Scores on the Visual Analog Scale (VAS) and in the Ocular Discomfort Scores on the Ocular Surface Disease Index (OSDI) as a Measure of SYL1001 Analgesic Effect versus Placebo.
Measured: 10 days + (4-10 days)
Simple Corneal and Conjunctival Evaluation as a Measure of Safety and Tolerability using Ophthalmic Dyes and a Slit Lamp
Measured: 10 days + (4-10 days)
Secondary outcomes (2)
Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability
Measured: 10 days + (96-240 hours)
Evaluation of Vital Signs, Blood, Urine and Ocular Parameters Alterations (IOP, Visual Acuity, Anterior Segment Exploration) Possibly Related to the Investigational Product
Measured: 10 days + (96-240 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ocular PainStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 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
- NCT01776658
- Sponsor's protocol ID
- SYL1001_II
- Status last verified
- May 2015
- First submitted
- 14 Nov 2012
- Last updated
- 25 May 2015
- Results posted
- No
Publications
Benitez-Del-Castillo JM, Moreno-Montanes J, Jimenez-Alfaro I, Munoz-Negrete FJ, Turman K, Palumaa K, Sadaba B, Gonzalez MV, Ruz V, Vargas B, Paneda C, Martinez T, Bleau AM, Jimenez AI. Safety and Efficacy Clinical Trials for SYL1001, a Novel Short Interfering RNA for the Treatment of Dry Eye Disease. Invest Ophthalmol Vis Sci. 2016 Nov 1;57(14):6447-6454. doi: 10.1167/iovs.16-20303.
PubMed 27893109
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate SYL1001 Safety and Effect in Patients With Ocular Pain
- ClinicalTrials.gov ID
- NCT01776658
- Acronym / sponsor ID
- SYL1001_II
- Conditions
- Ocular Pain, Dry Eye Syndrome
- Keywords
- Ocular pain, Dry Eye Syndrome, siRNA, RNAi, TRPV1
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sylentis, S.A.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Apr 2015 (actual)
- First posted
- 28 Jan 2013 (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 pilot study is to compare the analgesic effect of SYL1001 versus placebo in patients with ocular pain associated with Dry Eye Syndrome. General and local tolerability are also evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SYL1001 eye drops dose A | Experimental | Drug: SYL1001Ocular topical administration of SYL1001 eye drops dose A |
| 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)
- Patients of both genders
- Age ≥ 18 years old
- Give written informed consent to participate in the study after having been informed of the study design, objectives and possible derived risks
- Common mild to moderate dry eye symptoms. Persistent daily symptoms for more than three months:
- OSDI scale: 13-30
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 whole study.
- Current relevant disease, including respiratory disease, cardiovascular, endocrine, neurological, haematological, renal, neoplasic, hepatopathy, gastrointestinal distress, hypertension, or infectious acute processes.
- Past history of a chronic o recurring condition that could interfere with study according to the investigator's judgement.
- Concomitant use of other drugs with analgesic activity by any route of administration at the enrolment period.
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 |
|---|---|---|
| SYL1001Ocular topical administration of SYL1001 for 10 consecutive days | Drug | SYL1001 eye drops dose A |
| PlaceboOcular topical administration of placebo for 10 consecutive days | Drug | Placebo |
Primary outcome
Changes from Baseline in the Ocular Pain Scores on the Visual Analog Scale (VAS) and in the Ocular Discomfort Scores on the Ocular Surface Disease Index (OSDI) as a Measure of SYL1001 Analgesic Effect versus Placebo.
Time frame: 10 days + (4-10 days)
Simple Corneal and Conjunctival Evaluation as a Measure of Safety and Tolerability using Ophthalmic Dyes and a Slit Lamp
Time frame: 10 days + (4-10 days)
2 secondary outcomes
Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability
Time frame: 10 days + (96-240 hours)
Evaluation of Vital Signs, Blood, Urine and Ocular Parameters Alterations (IOP, Visual Acuity, Anterior Segment Exploration) Possibly Related to the Investigational Product
Time frame: 10 days + (96-240 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 25 May 2015.
- Derived from this study: PubMed 27893109Benitez-Del-Castillo JM, Moreno-Montanes J, Jimenez-Alfaro I, Munoz-Negrete FJ, Turman K, Palumaa K, Sadaba B, Gonzalez MV, Ruz V, Vargas B, Paneda C, Martinez T, Bleau AM, Jimenez AI. Safety and Efficacy Clinical Trials for SYL1001, a Novel Short Interfering RNA for the Treatment of Dry Eye Disease. Invest Ophthalmol Vis Sci. 2016 Nov 1;57(14):6447-6454. doi: 10.1167/iovs.16-20303.
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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.
3 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 SYL1001 in people with Ocular Pain and Dry Eye Syndrome, run by Sylentis, S.A. at 3 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 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 25 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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 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?
Changes from Baseline in the Ocular Pain Scores on the Visual Analog Scale (VAS) and in the Ocular Discomfort Scores on the Ocular Surface Disease Index (OSDI) as a Measure of SYL1001 Analgesic Effect versus Placebo. (time frame: 10 days + (4-10 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?
On the ClinicalTrials.gov record for NCT01776658, which also lists 1 linked publication.
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 25 May 2015.