SYL040012. Tolerance and Effect on Intraocular Pressure in Subjects With Intraocular Pressure (IOP) >= 21 mm Hg

Study With SYL040012. Tolerance and Effect on Intraocular Pressure in Subjects With IOP >= 21 mm Hg.

The aim of this study is to evaluate the tolerance and effect on unmedicated subjects with elevated IOP.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma
• Intervention / Treatment: Drug: SYL040012

Detailed Description

The aim of this study is to evaluate the tolerance and effect on unmedicated subjects with elevated IOP. An unmedicated subject is considered a person without any IOP/glaucoma treatment at least one month before recruitment.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universidad Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Both genders.
• >/= 18 years of age with elevated IOP with OAG diagnosis.
• Subjects must provide signed informed consent prior to participation in any study-related procedures
• IOP >/= 21 mmHg and < 30 mmHg in three different assessment days.

• Normal Ocular test (in both eyes):

  • Visual field: 24-2 or equivalent
  • Normal OCT
  • BCVA: >/= 0,5 (20/40) Snellen scale, or </=0.3 LogMar.
  • Normal Schirmer Test .
  • Normal funduscopy.

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 hole study.
• Current relevant disease, including respiratory disease, cardiovascular, endocrine, neurological, hematological, renal, neoplastic, hepatopathy, gastrointestinal distress, hypertension or infectious acute processes.
• Previous chronic processes or with rebound characteristics that could interfere with the study according to the investigator's judgment.
• Having used betablockers and corticoids sporadically in the last 15 days whichever the route of administration.
• Previous eye refractive surgery
• Subjects with visual alteration with more than 3 dioptres for hypermetropy and/or astigmatism.
• Use of contact lenses during the last 7 days before starting the treatment.
• Subjects who has participated in a clinical trial during the past 2 months before study entry.
• Analytic alterations medically relevant, at investigator judgment.
• Positive results in test drug abuse during selection period.
• Subjects with at least 2 visual fields or fiber layer measured in two different days abnormals
• History of ocular infection or inflammation within the past 3 months
• Pachymetry(in the middle of the cornea) >600 microm or < 500 microm.
• Subjects with IOP associated to close angle glaucoma
• History of chronic or severe acute ocular disease (i.e. scleritis, uveitis, blepharitis, conjunctivitis or herpes simplex virus)
• History of intolerance to any of the components of the drug formulation
• Subjects with previous iridotomy with IOP related with close angle glaucoma.
• Previous ocular surgery in glaucoma
• Corneal refractive surgery (e.g., keratotomy, PRK, LASIK, etc)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SYL040012; SYL040012 Ophthalmic drop administration	Drug: SYL040012; SYL040012 ophthalmic drops, daily single dose administration; Other Names: No additional names

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerance on ocular surface (ocular and conjunctiva)	Local Tolerance and ocular surface(cornea and conjunctival) on the area of administration 24 hours after last administration of multiple dose during 7 days of administration. It will be performed using a slit lamp which will be performed before, during and after the administration at established times. Adverse events will be registered and the determination of subjective tolerance will use the visual analogical scale (VAS) in cases where a subjects refers them.	7 days + 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerance, Adverse events, Pharmacokinetics and effect	Local Tolerance on the area of administration at 1 hour and 96 hours after the last administered dose: corneal pachymetry, rest of anterior exploration of the eye, visual acuity, eye fundus, clinical exam (including physical exploration, vital signs, analytical blood and urine test, and ECG. Other parameters: analytics, VAS evaluation, Evaluation of adverse event appearance Pharmacokinetics: SYL040012 blood absorption will be evaluated after topical ocular administration Effect on IOP	11 days

Collaborators and Investigators

• Sponsor: Sylentis, S.A.
• Investigators: Principal Investigator: Javier Moreno, MD, PhD, Clinica Universidad de Navarra; Principal Investigator: Francisco Muñoz, MD, PhD, Hospital Universitario Ramon y Cajal

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: October 21, 2010
• First Submitted That Met QC Criteria: October 22, 2010
• First Posted (Estimate): October 25, 2010

Study Record Updates

• Last Update Posted (Estimate): September 27, 2012
• Last Update Submitted That Met QC Criteria: September 26, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Glaucoma; IOP; siRNAs; RNAi; beta inhibitor
• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Ocular Hypertension
• Other Study ID Numbers: SYL040012_II

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No