Clinical trial NCT01227291: SYL040012. Tolerance and Effect on Intraocular Pressure in Subjects With Intraocular Pressure (IOP) >= 21 mm Hg
Official title: Study With SYL040012. Tolerance and Effect on Intraocular Pressure in Subjects With IOP >= 21 mm Hg.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Glaucoma
Ocular Hypertension
Keywords: Glaucoma
IOP
siRNAs
RNAi
beta inhibitor
Lead sponsor: Sylentis, S.A.
Sponsor class: INDUSTRY
First posted: 2010-10-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Tolerance on ocular surface (ocular and conjunctiva)
timeFrame: 7 days + 24 hours
Secondary outcomes:
measure: Tolerance, Adverse events, Pharmacokinetics and effect
timeFrame: 11 days
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Clinica Universidad Navarra
state: Navarra
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
Study officials:
affiliation: Clinica Universidad de Navarra
name: Javier Moreno, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Ramon y Cajal
name: Francisco Muñoz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: