Moderate to severe dry eye disease (DED) MedDRA version: 19.1 Level: PT Classification code 10013774 Term: Dry eye System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: SYL1001
Product Code: SYL1001
Pharmaceutical Form: Eye drops, solution in single-dose container
INN or Proposed INN: SYL1001
CAS Number: 1848239-71-3
Current Sponsor code: SYL1001
Concen
Sponsors
Sylentis SAU - PharmaMar Group
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
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 from enrolment until after the final visit. Medically acceptable contraceptive methods include vasectomised sexual partner, bilateral tubal ligation, intrauterine devices or implants, normal or low dose combination oral pills, injectable contraceptive, ethinylestradiol transdermal system intravaginal devices and documented use of condoms. True sexual abstinence (starting from enrollment until after the follow-up visit) is also an acceptable contraceptive method. 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 participated in SYL1001_IV trial. 15. Non-compliance after the run-in period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Day 28;Main Objective: Assessment of efficacy of SYL1001 at 11.25 mg/mL on signs and symptoms of DED;Secondary Objective: Safety assessment : local and systemic tolerability, and Adverse Events;Primary end point(s): o Change from Baseline in Visual Analogue Scale (VAS) scores for eye discomfort/pain after 28 days of treatment o Change from Baseline in Corneal Fluorescein Staining (CFS) total scores obtained on the Oxford scale after 28 days of treatment o Change from Baseline in conjunctival hyperaemia scores based on the McMonnies scale after 28 days of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Day 14 and Day 28 Throughout the study for tolerability and Adverse Events;Secondary end point(s): o Change from baseline in VAS scores for eye discomfort/pain at Day 14 o Change from baseline in each of the scores of the dry eye symptoms index (DESI) after 14 and 28 days of treatment o Change from baseline in CFS total scores obtained on the Oxford scale ater 14 days of treatment o Change from baseline in CFS central, nasal, temporal, superior and inferior scoring after 14 and 28 days of treatment o Change from baseline in conjunctival hyperaemia scores based on the McMonnies scale after 14 days of treatment o Change from baseline in Tear break-up lime (TBUT) and conjunctival staining scores after 14 and 28 days of treatment o Change from baseline in Schirmer's tests values at Days 14 and 28. o Number of artificial tears drops per day o Assessment of the impact of treatment on the QoL (NEI-VFQ) questionnaire at Day 28. o Assessment of the impact of treatment on local and systemic tolerability. o Assessment of other Adverse Events (AEs) occurrence | — |
Countries
Estonia, Germany, Italy, Portugal, Slovakia, Spain
Contacts
Public ContactRegulatory Affairs
Sylentis
Outcome results
None listed