Ocular PainPhase 2NCT02455999
Dose-finding Study to Assess the Safety and Effect of SYL1001 in Patients With Ocular Pain
A Phase 2 study testing SYL1001 in people with Ocular Pain and Dry Eye Syndrome, run by Sylentis, S.A. at 6 sites in 2 countries.
Trial summary
The aim of this pilot study is to compare the analgesic effect of two strengths of SYL1001 eye drops 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
- 66 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jun 2015to Mar 2016
- 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
- Give written informed consent to participate in the study, after having received all information relating to the design, aims and possible risks resulting therefrom.
- Common symptoms of persistent, daily, mild to moderate dry eye lasting more than three months: OSDI scale between 13-70 and VAS scale between 2 -7.
- Eye tests in both eyes: Corneal fluorescein staining (Oxford scale > 0), Tear break-up time < 10 seconds and Schirmer's test with anaesthesia < 10 mm/5min.
Who cannot join
- Women who are pregnant or breastfeeding or who have a positive urine pregnancy test. Women who do not commit to use a medically acceptable method of contraception from the time of selection and throughout the study.
- Any current, relevant disease, including respiratory disease, cardiovascular disease, endocrine disease, neurological disease, haematological disease, kidney disease, oncological disease, liver disease, gastrointestinal dysfunction, hypertension or active acute infectious processes.
- Previous chronic or recurrent processes which, according to the investigator, could affect the development of the study.
- Concomitant use of other medications with analgesic activity by any route of administration at the time of entry into the study.
- Change in any concomitant eye and/or systemic medication of the patient one month before the study and during the study.
- Changes in the pre-established administration schedule of artificial tears during the 15 days before the study and during the 10 days of the study.
Show all 14Show fewer
- Initiation of treatment with cyclosporine or changes in the dosage or administration schedule of cyclosporine within the 6 months before inclusion in the study.
- History of hypersensitivity to drugs.
- Use of contact lenses during the treatment and previous 15 days.
- History of drug abuse or drug or alcohol dependence.
- Laboratory abnormalities which, in the investigator's opinion, are clinically significant.
- Previous refractive surgery.
- Having participated in another clinical trial within the 2 months prior to inclusion.
- Another eye disease that is significant in the investigator's opinion.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Spain4 sites
Hospital Universitario Ramón y Cajal
Madrid, 28034
Fundación Jiménez Díaz
Madrid, 28040
Hospital U. Clínico San Carlos
Madrid, 28040
Clínica Universidad de Navarra
Pamplona, 31008
Estonia2 sites
East Tallinn Central Hospital
Tallinn, 10138
Eye Clinic Dr. Krista Turman
Tallinn, 13419
About this study
The aim of this pilot study is to compare the analgesic effect of two strengths of SYL1001 eye drops 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
- 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
SYL1001 eye drops dose C administration for 10 consecutive days
SYL1001Drug
SYL1001 eye drops dose D administration for 10 consecutive days
PlaceboDrug
Placebo eye drops administration for 10 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| SYL1001 eye drops dose C | Experimental | SYL1001 eye drops dose C administration via the ophthalmic route Receives: Drug: SYL1001 |
| SYL1001 eye drops dose D | Experimental | SYL1001 eye drops dose D administration via the ophthalmic route Receives: Drug: SYL1001 |
| Placebo | Placebo comparator | Placebo eye drops administration via the ophthalmic route Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from the baseline scoring of eye pain on the Visual Analogue Scale (VAS)
Measured: 10 consecutive days
Change from the baseline scoring of ocular discomfort in the Ocular Surface Disease Index (OSDI)
Measured: 10 consecutive days
Change from the baseline scoring after fluorescein staining of the cornea
Measured: 10 consecutive days
Frequency of occurrence of conjunctival hyperaemia
Measured: 10 consecutive days
Secondary outcomes (4)
Change from baseline in vital signs
Measured: 10 consecutive days
Change from baseline in standard laboratory parameters
Measured: 10 consecutive days
Assessment of Adverse Events (AEs) as a measure of SYL1001 safety
Measured: 20 consecutive days
Change from baseline in standard ocular parameters
Measured: 10 consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2016
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 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
- NCT02455999
- Sponsor's protocol ID
- SYL1001_III
- Status last verified
- Apr 2016
- First submitted
- 20 May 2015
- Last updated
- 5 Apr 2016
- 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 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-finding Study to Assess the Safety and Effect of SYL1001 in Patients With Ocular Pain
- ClinicalTrials.gov ID
- NCT02455999
- Acronym / sponsor ID
- SYL1001_III
- Conditions
- Ocular Pain, Dry Eye Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Sylentis, S.A.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Mar 2016 (actual)
- First posted
- 28 May 2015 (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 two strengths of SYL1001 eye drops 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
- 3
| Arm | Type | Receives |
|---|---|---|
| SYL1001 eye drops dose C | Experimental | Drug: SYL1001SYL1001 eye drops dose C administration via the ophthalmic route |
| SYL1001 eye drops dose D | Experimental | Drug: SYL1001SYL1001 eye drops dose D administration via the ophthalmic route |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo eye drops administration via the ophthalmic route |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Give written informed consent to participate in the study, after having received all information relating to the design, aims and possible risks resulting therefrom.
- Common symptoms of persistent, daily, mild to moderate dry eye lasting more than three months: OSDI scale between 13-70 and VAS scale between 2 -7.
- Eye tests in both eyes: Corneal fluorescein staining (Oxford scale > 0), Tear break-up time < 10 seconds and Schirmer's test with anaesthesia < 10 mm/5min.
Key exclusion criteria (14 listed)
- Women who are pregnant or breastfeeding or who have a positive urine pregnancy test. Women who do not commit to use a medically acceptable method of contraception from the time of selection and throughout the study.
- Any current, relevant disease, including respiratory disease, cardiovascular disease, endocrine disease, neurological disease, haematological disease, kidney disease, oncological disease, liver disease, gastrointestinal dysfunction, hypertension or active acute infectious processes.
- Previous chronic or recurrent processes which, according to the investigator, could affect the development of the study.
- Concomitant use of other medications with analgesic activity by any route of administration at the time of entry into the study.
- Change in any concomitant eye and/or systemic medication of the patient one month before the study and during the study.
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 |
|---|---|---|
| SYL1001SYL1001 eye drops dose C administration for 10 consecutive days | Drug | SYL1001 eye drops dose C |
| SYL1001SYL1001 eye drops dose D administration for 10 consecutive days | Drug | SYL1001 eye drops dose D |
| PlaceboPlacebo eye drops administration for 10 consecutive days | Drug | Placebo |
Primary outcome
Change from the baseline scoring of eye pain on the Visual Analogue Scale (VAS)
Time frame: 10 consecutive days
Change from the baseline scoring of ocular discomfort in the Ocular Surface Disease Index (OSDI)
Time frame: 10 consecutive days
Change from the baseline scoring after fluorescein staining of the cornea
Time frame: 10 consecutive days
Frequency of occurrence of conjunctival hyperaemia
Time frame: 10 consecutive days
4 secondary outcomes
Change from baseline in vital signs
Time frame: 10 consecutive days
Change from baseline in standard laboratory parameters
Time frame: 10 consecutive days
Assessment of Adverse Events (AEs) as a measure of SYL1001 safety
Time frame: 20 consecutive days
Change from baseline in standard ocular parameters
Time frame: 10 consecutive 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 5 Apr 2016.
- 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.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SYL1001 in people with Ocular Pain and Dry Eye Syndrome, run by Sylentis, S.A. at 6 sites in 2 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 3 inclusion and 14 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 5 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain, 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?
Change from the baseline scoring of eye pain on the Visual Analogue Scale (VAS) (time frame: 10 consecutive days). The study lists 4 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 NCT02455999, 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 5 Apr 2016.