CompletedInterventionalPhase 1Updated Oct 22, 2010
Pilot Study to Evaluate SYL1001 Safety and Effect in Patients With Ocular Pain | NCT01776658 | Trialant
CompletedInterventionalPhase 1Phase 2Updated May 25, 2015
Pilot Study to Evaluate SYL1001 Safety and Effect in Patients With Ocular Pain
ClinicalTrials.gov ID
NCT01776658
Lead Sponsor
Sylentis, S.A.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1Phase 2
Enrollment
60Actual
Last Update Posted
May 25, 2015Estimated
Start Date
Nov 2012
Primary Completion Date
Apr 2015Actual
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.
Ocular Pain
Dry Eye Syndrome
SYL1001
Placebo
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.