Pilot Study to Evaluate SYL1001 Safety and Effect in Patients With Ocular Pain
This study is currently recruiting participants.
Verified January 2013 by Sylentis, S.A.
Sponsor:
Sylentis, S.A.
Information provided by (Responsible Party):
Sylentis, S.A.
ClinicalTrials.gov Identifier:
NCT01776658
First received: November 14, 2012
Last updated: January 23, 2013
Last verified: January 2013
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Purpose
The aim of this pilot study is to compare the analgesic effect of SYL1001 versus placebo in patients with ocular pain associated with Dry Eye Syndrome. General and local tolerability are also evaluated.
| Condition | Intervention | Phase |
|---|---|---|
|
Ocular Pain Dry Eye Syndrome |
Drug: SYL1001 Drug: Placebo |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Sylentis, S.A.:
Primary Outcome Measures:
- Changes from Baseline in the Ocular Pain Scores on the Visual Analog Scale (VAS) and in the Ocular Discomfort Scores on the Ocular Surface Disease Index (OSDI) as a Measure of SYL1001 Analgesic Effect versus Placebo. [ Time Frame: 10 days + (4-10 days) ] [ Designated as safety issue: No ]
- Simple Corneal and Conjunctival Evaluation as a Measure of Safety and Tolerability using Ophthalmic Dyes and a Slit Lamp [ Time Frame: 10 days + (4-10 days) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability [ Time Frame: 10 days + (96-240 hours) ] [ Designated as safety issue: Yes ]
- Evaluation of Vital Signs, Blood, Urine and Ocular Parameters Alterations (IOP, Visual Acuity, Anterior Segment Exploration) Possibly Related to the Investigational Product [ Time Frame: 10 days + (96-240 hours) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | November 2012 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SYL1001 eye drops dose A
Ocular topical administration of SYL1001 eye drops dose A
|
Drug: SYL1001
Ocular topical administration of SYL1001 for 10 consecutive days
|
|
Placebo Comparator: Placebo
Ocular topical administration of placebo eye drops
|
Drug: Placebo
Ocular topical administration of placebo for 10 consecutive days
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients of both genders
- Age ≥ 18 years old
- Give written informed consent to participate in the study after having been informed of the study design, objectives and possible derived risks
- Common mild to moderate dry eye symptoms. Persistent daily symptoms for more than three months:
- OSDI scale: 13-30
- VAS scale: 2-7
- Ocular tests in both eyes:
- Corneal staining with fluorescein. Oxford scale > 0
- Tear Breakup Time Test: (BUT) < 10 seconds
- Schirmer test with anaesthesia < 10 mm/5min
Exclusion Criteria:
- Pregnant or breastfeeding females or those with a positive pregnancy test.
- Females of childbearing potential who will not use a medically acceptable contraceptive method from selection and during the whole study.
- Current relevant disease, including respiratory disease, cardiovascular, endocrine, neurological, haematological, renal, neoplasic, hepatopathy, gastrointestinal distress, hypertension, or infectious acute processes.
- Past history of a chronic o recurring condition that could interfere with study according to the investigator's judgement.
- Concomitant use of other drugs with analgesic activity by any route of administration at the enrolment period.
- Changes in any ocular and/or systemic concomitant medication one month prior to the study commencement and during the study development.
- Changes on the preestablished artificial tears dosage 15 days prior to the study commencement and during the study development.
- Cyclosporine treatment initiation or changes in cyclosporine dosage or dosing regimen during the 6 months prior to enrolment.
- Previous history of drug hypersensitivity.
- Use of contact lenses
- Case history of drug or alcohol abuse or dependence.
- Relevant abnormal laboratory results as judged by the investigator
- Previous refractive surgery
- Participation in a clinical trial within 2 months before the enrolment visit
- Relevant ocular pathology judged by the investigator.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776658
Contacts
| Contact: Verónica Ruz, PhD | vruz@sylentis.com |
Locations
| Spain | |
| Hospital Universitario Clínico San Carlos | Recruiting |
| Madrid, Spain, 28040 | |
| Fundación Jiménez Díaz | Recruiting |
| Madrid, Spain, 28040 | |
| Instituto Oftalmológico Fernández-Vega | Recruiting |
| Oviedo, Spain, 33012 | |
Sponsors and Collaborators
Sylentis, S.A.
More Information
No publications provided
| Responsible Party: | Sylentis, S.A. |
| ClinicalTrials.gov Identifier: | NCT01776658 History of Changes |
| Other Study ID Numbers: | SYL1001_II |
| Study First Received: | November 14, 2012 |
| Last Updated: | January 23, 2013 |
| Health Authority: | Spain: Agencia Española de Medicamentos y Productos Sanitarios Spain: Comité Ético de Investigación Clínica |
Keywords provided by Sylentis, S.A.:
|
Ocular pain Dry Eye Syndrome siRNA RNAi TRPV1 |
Additional relevant MeSH terms:
|
Dry Eye Syndromes Keratoconjunctivitis Sicca Eye Pain Lacrimal Apparatus Diseases Eye Diseases Keratoconjunctivitis Conjunctivitis |
Conjunctival Diseases Keratitis Corneal Diseases Eye Manifestations Signs and Symptoms Pain |
ClinicalTrials.gov processed this record on June 18, 2013