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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01227291
• Other study ID #: SYL040012_II
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 21, 2010
• Last updated: September 26, 2012
• Start date: October 2010
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: Sylentis, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Ocular Hypertension

Intervention

Drug:
• SYL040012
SYL040012 ophthalmic drops, daily single dose administration

Locations

Country	Name	City	State
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Clinica Universidad Navarra	Pamplona	Navarra

Sponsors (1)

Lead Sponsor	Collaborator
Sylentis, S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	11 days	Yes