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

• Register: ClinicalTrials.gov
• Last refreshed on: 18 April 2016
• Main ID: NCT02455999
• Date of registration: 20/05/2015
• Prospective Registration: Yes
• Primary sponsor: Sylentis, S.A.
• Public title: Dose-finding Study to Assess the Safety and Effect of SYL1001 in Patients With Ocular Pain
• Date of first enrolment: June 2015
• Target sample size: 66
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02455999
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Estonia, Spain

Key inclusion & exclusion criteria

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:

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Dry Eye Syndrome

Ocular Pain

Intervention(s)

Drug: SYL1001

Drug: Placebo

Primary Outcome(s)

Change from the baseline scoring of eye pain on the Visual Analogue Scale (VAS) [Time Frame: 10 consecutive days]

Change from the baseline scoring of ocular discomfort in the Ocular Surface Disease Index (OSDI) [Time Frame: 10 consecutive days]

Frequency of occurrence of conjunctival hyperaemia [Time Frame: 10 consecutive days]

Change from the baseline scoring after fluorescein staining of the cornea [Time Frame: 10 consecutive days]

Secondary Outcome(s)

Change from baseline in standard ocular parameters [Time Frame: 10 consecutive days]

Change from baseline in standard laboratory parameters [Time Frame: 10 consecutive days]

Assessment of Adverse Events (AEs) as a measure of SYL1001 safety [Time Frame: 20 consecutive days]

Change from baseline in vital signs [Time Frame: 10 consecutive days]

Secondary ID(s)

SYL1001_III

Source(s) of Monetary Support

Please refer to primary and secondary sponsors