SYL040012. Tolerance and Effect on Intraocular Pressure in Subjects With Intraocular Pressure (IOP) >= 21 mm Hg
This study has been completed.
Information provided by (Responsible Party):
First received: October 21, 2010
Last updated: September 26, 2012
Last verified: September 2012
The aim of this study is to evaluate the tolerance and effect on unmedicated subjects with elevated IOP.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Study With SYL040012. Tolerance and Effect on Intraocular Pressure in Subjects With IOP >= 21 mm Hg.
Primary Outcome Measures:
- Tolerance on ocular surface (ocular and conjunctiva) [ Time Frame: 7 days + 24 hours ] [ Designated as safety issue: Yes ]
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.
Secondary Outcome Measures:
- Tolerance, Adverse events, Pharmacokinetics and effect [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]
Local Tolerance on the area of administration at 1 hour and 96 hours after the last administered dose: corneal pachymetry, rest of anterior exploration of the eye, visual acuity, eye fundus, clinical exam (including physical exploration, vital signs, analytical blood and urine test, and ECG.
Other parameters: analytics, VAS evaluation, Evaluation of adverse event appearance Pharmacokinetics: SYL040012 blood absorption will be evaluated after topical ocular administration Effect on IOP
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2012 (Final data collection date for primary outcome measure)
SYL040012 Ophthalmic drop administration
SYL040012 ophthalmic drops, daily single dose administration
Other Name: No additional names
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227291
|Clinica Universidad Navarra
|Pamplona, Navarra, Spain, 31008 |
|Hospital Universitario Ramón y Cajal
|Madrid, Spain, 28034 |
||Javier Moreno, MD, PhD
||Clinica Universidad de Navarra
||Francisco Muñoz, MD, PhD
||Hospital Ramón y Cajal
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 21, 2010
||September 26, 2012
||Spain: Spanish Agency of Medicines
Keywords provided by Sylentis, S.A.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 23, 2013