SYL040012. Tolerance and Effect on Intraocular Pressure i... | NCT01227291

NCT01227291

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
SYL040012	Experimental	SYL040012 Ophthalmic drop administration	Drug: SYL040012

Name	Type	Description	Arm Group Labels	Other Names
SYL040012	Drug	SYL040012 ophthalmic drops, daily single dose administration	SYL040012

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Tolerance, Adverse events, Pharmacokinetics and effect	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

Eligibility Module

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)

Name	Affiliation	Role
Javier Moreno, MD, PhD	Clinica Universidad de Navarra	Principal Investigator
Francisco Muñoz, MD, PhD	Hospital Universitario Ramon y Cajal	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario Ramón y Cajal		Madrid	Madrid	28034	Spain
Clinica Universidad Navarra

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension