A double-masked study of SYL1001 in patients with moderate tosevere dry eye disease (DED).

Phase 1

Conditions: Moderate to severe dry eye disease (DED)
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2016-003903-79-IT

Lead Sponsor: SYLENTIS S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 289

Inclusion Criteria

1)Patient is a male or a female aged = 18 years at screening visit. 2) Have given their written consent to participate in the study,
after having received all information relating to the design, aims and possible
risks resulting therefrom. 3)Common symptoms of persistent, daily, moderate to severe dry eye
lasting more than six months. 4)Use of artificial tears during the last 30 days prior to the selection phase
5)VAS scale for eye discomfort/pain between 30 - 80 in one of the eyes and = 20 in the fellow eye.
6)CFS = 2 and = 4 on the Oxford scale (0-5) in at least 1 eye region in the eye with the highest VAS scoring for eye
discomfort/pain. 7)TBUT < 10 seconds in the eye with the highest VAS scoring for eye discomfort/pain. TBUT =1 in both eyes.
8)Hyperemia score =1 (McMonnies scale) in the eye with the highest VAS scoring for eye discomfort/pain. 9)Schirmer's test
without anesthesia = 2 and < 10 mm/5min in the eye with the highest VAS scoring for eye discomfort/pain. Value = 2 in the fellow
eye. 10)Corrected visual acuity = 0.7 logMAR (20/100 Snellen or 50 ETDRS) in both eyes.11)If the subject is selected in a French
site, he/she must be covered by a National Social Security System at screening visit.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

1)Pregnant or breastfeeding females or females with a positive pregnancy test at the screening visits. 2)Females of childbearing
potential not willing to use
a medically acceptable contraceptive method (definition in section 6.3) from enrolment until after the final visit. 3)Current,
previous chronic or recurrent medical condition which, according to the investigator, might impact the interpretation of the study
results or put the subject at risk.4)Current concomitant use of any medications with analgesic activity (such as regular pain killer
users) by any route of administration at the time of entry into the study and during the study. 5)Change in concomitant systemic
medication one month before the study and during the study that might impact the interpretation of the results according to the
investigator. 6)Concomitant treatment with cyclosporine, tacrolimus, sirolimus (systemic or ophthalmic) for the previous 2 months
before entering the study. 7)Any eye concomitant treatment at the time of entry into the study. Unpreserved artificial tears will be
provided by the Sponsor to use throughout the study. A maximum of 4 daily drops is allowed. 8)History of hypersensitivity to
SYL1001, to any component of the formulation or to ophthalmic diagnostic agents. 9)Use of contact lenses or punctual plugs
during the treatment and the previous 7 days (prior to treatment initiation). 10)Clinically significant laboratory abnormalities
according to investigator's opinion. 11)Previous refractive surgery, cornea transplant. Meibomian gland dysfunction or history of lid
malposition (ectropion, entropion, ptosis) that may affect acurate assessment of the disease and/or mask the effects of the drug.
12)Any other ocular surgery in the past 1 year. 13)Any other eye disease that is significant in the investigator's opinion.
14)Currently participating or having participated in another clinical trial within the 2 months prior to inclusion. Patient that already
participatedin SYL1001_IV trial.15) Non-compliance after the run-in period.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method