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

Sylentis

Status and phase

Completed

Phase 2

Phase 1

Conditions

Ocular Pain

Dry Eye Syndrome

Treatments

Drug: SYL1001

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01776658

SYL1001_II

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.