Clinical trial NCT01438281: Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy Volunteers
Official title: Phase I Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ocular Pain
Dry Eye
Keywords: ocular pain
dry eye
siRNA
Lead sponsor: Sylentis, S.A.
Sponsor class: INDUSTRY
First posted: 2011-09-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether SYL1001 is safe for the prevention and treatment of ocular pain and dry eye syndrome.


Eligibility criteria: Inclusion Criteria:

* Subjects must provide signed inform consent prior to participation.
* BMI between 19,5 y 29 kg/m2.
* Normal ocular test in both eyes: IOP \</=21 mmHg. BCVAof \>/=0,8 (20/25)Snellen scale, or \</=0.1 LogMar.
* Normal fluorescein Clearance Test in both eyes.
* Normal funduscopy in both eyes.

Exclusion Criteria:

* Pregnant or breastfeeding females or those with a positive pregnancy test or who will not use a medically acceptable contraceptive method from selection and during the study.
* Current relevant disease.
* Previous chronic processes or with rebound characteristics that could interfere with study according investigator's judgment.
* Volunteers who have received pharmacological treatment, including medicinal plants, during the four weeks previous to beginning the study.
* Having used corticoids sporadically in the last 30 days whichever the route aof administration, or any med by ocular or nasal administration route.
* Case history of hypersensitivity to meds or any other allergic process.
* Visual alterations: previous eye surgery, glaucoma, use of lenses, uveitis or ocular surface pathology (dry eye, blepharitis).
* Volunteers with visual alteration with more than 3 dioptres in either eye.
* Volunteers who has participated in a clinical trial during the past fout months before study entry.
* Blood or derivate transfusion during the six previous months to study entry.
* Case history of drug or alcohol abuse or dependence.
* Positive result in test drug abuse during selection period.
* positive serology results to hepatitis B virus(HbsAg), virus C o VIH.
* Analytic alterations medically relevant, at investigator's judgement.

Primary outcomes:
measure: Local tolerance assessment of cornea and conjunctival sac after administration of one dose of SYL1001 for period 1 and after 7 days of administration of SYL1001 with one dose per day for period 2.
timeFrame: Period I: 3 days, Period II: 11 days
Secondary outcomes:
measure: General tolerance assessment after administration of one dose of SYL1001 (period 1) and after 7 days administration (period 2)
timeFrame: Period I: 3 days; Period II: 11 days
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
Study officials:
affiliation: Clinica Universidad de Navarra
name: Belen Sadaba, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Benitez-Del-Castillo JM, Moreno-Montanes J, Jimenez-Alfaro I, Munoz-Negrete FJ, Turman K, Palumaa K, Sadaba B, Gonzalez MV, Ruz V, Vargas B, Paneda C, Martinez T, Bleau AM, Jimenez AI. Safety and Efficacy Clinical Trials for SYL1001, a Novel Short Interfering RNA for the Treatment of Dry Eye Disease. Invest Ophthalmol Vis Sci. 2016 Nov 1;57(14):6447-6454. doi: 10.1167/iovs.16-20303.