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

Sylentis

Status and phase

Completed

Phase 2

Phase 1

Conditions

Glaucoma

Ocular Hypertension

Treatments

Drug: SYL040012

Study type

Interventional

Funder types

Industry

Identifiers

NCT01227291

SYL040012_II

Details and patient eligibility

About

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

Full 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)