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

Study Overview
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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.

Conditions
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Ocular Pain, Dry Eye Syndrome

Intervention / Treatment
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* Drug: SYL1001
* Drug: SYL1001
* Drug: Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SYL1001 eye drops dose C<br>SYL1001 eye drops dose C administration via the ophthalmic route | Drug: SYL1001<br>* SYL1001 eye drops dose C administration for 10 consecutive days<br>|
| Experimental: SYL1001 eye drops dose D<br>SYL1001 eye drops dose D administration via the ophthalmic route | Drug: SYL1001<br>* SYL1001 eye drops dose D administration for 10 consecutive days<br>|
| Placebo Comparator: Placebo<br>Placebo eye drops administration via the ophthalmic route | Drug: Placebo<br>* Placebo eye drops administration for 10 consecutive days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |