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CompletedNCT02455999Updated Apr 5, 2016

Dose-finding Study to Assess the Safety and Effect of SYL1001 in Patients With Ocular Pain

A Phase 2 interventional study of SYL1001 and SYL1001 in Ocular Pain and Dry Eye Syndrome, sponsored by Sylentis, S.A.. Completed at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-05.

Sponsored by Sylentis, S.A. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Ocular Pain
  • Dry Eye Syndrome
03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's enrollment of 66 is close to the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Sylentis, S.A. is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion criteria:

  • 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.
  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    SYL1001 eye drops dose C

    SYL1001 eye drops dose C administration via the ophthalmic route

    Drug: SYL1001

  • Experimental
    SYL1001 eye drops dose D

    SYL1001 eye drops dose D administration via the ophthalmic route

    Drug: SYL1001

  • Placebo comparator
    Placebo

    Placebo eye drops administration via the ophthalmic route

    Drug: Placebo

Interventions

  • DrugSYL1001

    SYL1001 eye drops dose C administration for 10 consecutive days

  • DrugSYL1001

    SYL1001 eye drops dose D administration for 10 consecutive days

  • DrugPlacebo

    Placebo eye drops administration for 10 consecutive days

06

What researchers measure

Primary outcomes

  1. Change from the baseline scoring of eye pain on the Visual Analogue Scale (VAS)

    Time frame: 10 consecutive days

  2. Change from the baseline scoring of ocular discomfort in the Ocular Surface Disease Index (OSDI)

    Time frame: 10 consecutive days

  3. Change from the baseline scoring after fluorescein staining of the cornea

    Time frame: 10 consecutive days

  4. Frequency of occurrence of conjunctival hyperaemia

    Time frame: 10 consecutive days

Secondary outcomes

  1. Change from baseline in vital signs

    Time frame: 10 consecutive days

  2. Change from baseline in standard laboratory parameters

    Time frame: 10 consecutive days

  3. Assessment of Adverse Events (AEs) as a measure of SYL1001 safety

    Time frame: 20 consecutive days

  4. Change from baseline in standard ocular parameters

    Time frame: 10 consecutive days

07

Study locations

6 sites
  • East Tallinn Central Hospital
    Tallinn, 10138, Estonia
  • Eye Clinic Dr. Krista Turman
    Tallinn, 13419, Estonia
  • Hospital Universitario Ramón y Cajal
    Madrid, 28034, Spain
  • Fundación Jiménez Díaz
    Madrid, 28040, Spain
  • Hospital U. Clínico San Carlos
    Madrid, 28040, Spain
  • Clínica Universidad de Navarra
    Pamplona, 31008, Spain
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02455999
Lead sponsor
Sylentis, S.A.
Responsible party
Sponsor
First posted
May 28, 2015
Start date
Jun 2015
Primary completion
Mar 2016
Last update
Apr 5, 2016
View the source record on ClinicalTrials.gov ↗

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