A double-masked study of SYL1001 in patients with moderate to severe dry eye disease

Phase 1

• Conditions: Moderate to severe dry eye disease (DED); MedDRA version: 19.1Level: PTClassification code 10013774Term: Dry eyeSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2016-003903-79-ES
• Lead Sponsor: Sylentis SAU - PharmaMar Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-10
• Study Completion: 2018-11-16
• Last Update Posted: 8 October 2021

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 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified