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

NCT ID: NCT01227291

Last Updated: 2012-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-09-30

Brief Summary

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

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.

Conditions

Glaucoma; Ocular Hypertension

Keywords

Glaucoma; IOP; siRNAs; RNAi; beta inhibitor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SYL040012

SYL040012 Ophthalmic drop administration

Group Type: EXPERIMENTAL

SYL040012

Intervention Type: DRUG

SYL040012 ophthalmic drops, daily single dose administration

Interventions

SYL040012

SYL040012 ophthalmic drops, daily single dose administration

Intervention Type: DRUG

Other Intervention Names

No additional names

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sylentis, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Javier Moreno, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinica Universidad de Navarra

Francisco Muñoz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Ramon y Cajal

Locations

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Spain

Clinica Universidad Navarra

Pamplona, Navarre, Spain

Countries

Spain

Other Identifiers

SYL040012_II

Identifier Type: -

Identifier Source: org_study_id