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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Ocular Pain Dry Eye Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SYL1001 eye drops dose C

SYL1001 eye drops dose C administration via the ophthalmic route

Group Type EXPERIMENTAL

SYL1001

Intervention Type DRUG

SYL1001 eye drops dose C administration for 10 consecutive days

SYL1001 eye drops dose D

SYL1001 eye drops dose D administration via the ophthalmic route

Group Type EXPERIMENTAL

SYL1001

Intervention Type DRUG

SYL1001 eye drops dose D administration for 10 consecutive days

Placebo

Placebo eye drops administration via the ophthalmic route

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo eye drops administration for 10 consecutive days

Interventions

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SYL1001

SYL1001 eye drops dose C administration for 10 consecutive days

Intervention Type DRUG

SYL1001

SYL1001 eye drops dose D administration for 10 consecutive days

Intervention Type DRUG

Placebo

Placebo eye drops administration for 10 consecutive days

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No