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Pilot Study to Evaluate SYL1001 Safety and Effect in Patients With Ocular Pain

This study has been completed.
Information provided by (Responsible Party):
Sylentis, S.A. Identifier:
First received: November 14, 2012
Last updated: May 22, 2015
Last verified: May 2015
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.

Condition Intervention Phase
Ocular Pain Dry Eye Syndrome Drug: SYL1001 Drug: Placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Sylentis, S.A.:

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • 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) ]

Enrollment: 60
Study Start Date: November 2012
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SYL1001 eye drops dose A
Ocular topical administration of SYL1001 eye drops dose A
Drug: SYL1001
Ocular topical administration of SYL1001 for 10 consecutive days
Placebo Comparator: Placebo
Ocular topical administration of placebo eye drops
Drug: Placebo
Ocular topical administration of placebo for 10 consecutive days


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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.
  • 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01776658

Fundación Jiménez Díaz
Madrid, Spain, 28040
Hospital Universitario Clínico San Carlos
Madrid, Spain, 28040
Instituto Oftalmológico Fernández-Vega
Oviedo, Spain, 33012
Sponsors and Collaborators
Sylentis, S.A.
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sylentis, S.A. Identifier: NCT01776658     History of Changes
Other Study ID Numbers: SYL1001_II
Study First Received: November 14, 2012
Last Updated: May 22, 2015

Keywords provided by Sylentis, S.A.:
Ocular pain
Dry Eye Syndrome

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Pain
Lacrimal Apparatus Diseases
Eye Diseases
Conjunctival Diseases
Corneal Diseases
Neurologic Manifestations
Nervous System Diseases
Eye Manifestations
Signs and Symptoms
Ophthalmic Solutions
Pharmaceutical Solutions processed this record on July 27, 2017