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Completed

NCT Number: NCT01227291

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

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

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospital Universitario Ramón y Cajal, Madrid, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

SYL040012

Drug

SYL040012 ophthalmic drops, daily single dose administration

Other names: No additional names

Primary outcomes

  1. Tolerance on ocular surface (ocular and conjunctiva)

    Time frame: 7 days + 24 hours

    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 outcomes

  1. Tolerance, Adverse events, Pharmacokinetics and effect

    Time frame: 11 days

    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

Sponsors and collaborators

Lead sponsor

Sylentis, S.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 25, 2010
Registry last updated
Sep 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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