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

Sponsor

Sylentis, S.A. (Industry)

Overall Status

Completed

CT.gov ID

NCT02455999

Collaborator

(none)

Enrollment

Locations

Arms

Patients Per Site

Study Details

Study Description

Brief Summary

The aim of this pilot study is to compare the analgesic effect of two strengths of SYL1001 eye drops versus placebo in patients with ocular pain associated with Dry Eye Syndrome. General and local tolerability are also evaluated.

Condition or Disease	Intervention/Treatment	Phase
Ocular Pain Dry Eye Syndrome	Drug: SYL1001 Drug: SYL1001 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Jun 1, 2015

Actual Primary Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SYL1001 eye drops dose C SYL1001 eye drops dose C administration via the ophthalmic route	Drug: SYL1001 SYL1001 eye drops dose C administration for 10 consecutive days
Experimental: SYL1001 eye drops dose D SYL1001 eye drops dose D administration via the ophthalmic route	Drug: SYL1001 SYL1001 eye drops dose D administration for 10 consecutive days
Placebo Comparator: Placebo Placebo eye drops administration via the ophthalmic route	Drug: Placebo Placebo eye drops administration for 10 consecutive days

Arm

Intervention/Treatment

Experimental: SYL1001 eye drops dose C

SYL1001 eye drops dose C administration via the ophthalmic route

Drug: SYL1001

SYL1001 eye drops dose C administration for 10 consecutive days

Experimental: SYL1001 eye drops dose D

SYL1001 eye drops dose D administration via the ophthalmic route

Drug: SYL1001

SYL1001 eye drops dose D administration for 10 consecutive days

Placebo Comparator: Placebo

Placebo eye drops administration via the ophthalmic route

Drug: Placebo

Placebo eye drops administration for 10 consecutive days

Outcome Measures

Primary Outcome Measures

Change from the baseline scoring of eye pain on the Visual Analogue Scale (VAS) [10 consecutive days]
Change from the baseline scoring of ocular discomfort in the Ocular Surface Disease Index (OSDI) [10 consecutive days]
Change from the baseline scoring after fluorescein staining of the cornea [10 consecutive days]
Frequency of occurrence of conjunctival hyperaemia [10 consecutive days]

Secondary Outcome Measures

Change from baseline in vital signs [10 consecutive days]
Change from baseline in standard laboratory parameters [10 consecutive days]
Assessment of Adverse Events (AEs) as a measure of SYL1001 safety [20 consecutive days]
Change from baseline in standard ocular parameters [10 consecutive days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	East Tallinn Central Hospital	Tallinn	Estonia	10138
2	Eye Clinic Dr. Krista Turman	Tallinn	Estonia	13419
3	Hospital Universitario Ramón y Cajal	Madrid	Spain	28034
4	Fundación Jiménez Díaz	Madrid	Spain	28040
5	Hospital U. Clínico San Carlos	Madrid	Spain	28040
6	Clínica Universidad de Navarra	Pamplona	Spain	31008

Sponsors and Collaborators

Sylentis, S.A.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sylentis, S.A.

ClinicalTrials.gov Identifier:

NCT02455999

Other Study ID Numbers:

SYL1001_III

First Posted:

May 28, 2015

Last Update Posted:

Apr 5, 2016

Last Verified:

Apr 1, 2016

Additional relevant MeSH terms:

Dry Eye Syndromes

Eye Pain

Study Results

No Results Posted as of Apr 5, 2016