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

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sylentis, S.A.

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
• 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)