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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01776658
Recruitment Status : Completed
First Posted : January 28, 2013
Last Update Posted : May 25, 2015
Information provided by (Responsible Party):
Sylentis, S.A.

Brief 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.

Condition or disease Intervention/treatment Phase
Ocular Pain Dry Eye Syndrome Drug: SYL1001 Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : November 2012
Actual Primary Completion Date : April 2015

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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) ]
  2. 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 :
  1. Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability [ Time Frame: 10 days + (96-240 hours) ]
  2. 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) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01776658

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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.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sylentis, S.A. Identifier: NCT01776658    
Other Study ID Numbers: SYL1001_II
First Posted: January 28, 2013    Key Record Dates
Last Update Posted: May 25, 2015
Last Verified: May 2015
Keywords provided by Sylentis, S.A.:
Ocular pain
Dry Eye Syndrome
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Pain
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Eye Manifestations
Signs and Symptoms
Neurologic Manifestations
Ophthalmic Solutions
Pharmaceutical Solutions