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

NCT01227291 | Completed Phase 1 DMC

• 1 other identifier: SYL040012_II
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Glaucoma; Ocular Hypertension

Keywords

Glaucoma; IOP; siRNAs; RNAi; beta inhibitor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Tolerance, Adverse events, Pharmacokinetics and effect

  11 days

Study Arms (1)

SYL040012

EXPERIMENTAL

SYL040012 Ophthalmic drop administration

Drug: SYL040012

Interventions

SYL040012 DRUG

SYL040012 ophthalmic drops, daily single dose administration

Also known as: No additional names

SYL040012

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sylentis, S.A.: lead

Study Sites (2)

Hospital Universitario Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

Clinica Universidad Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Javier Moreno, MD, PhD

  Clinica Universidad de Navarra

  PRINCIPAL INVESTIGATOR

• Francisco Muñoz, MD, PhD

  Hospital Universitario Ramon y Cajal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2010
• First Posted: October 25, 2010
• Study Start: October 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 27, 2012

Record last verified: 2012-09

Locations

ES (2)