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OpenTrials
Completed

NCT Number: NCT01493271

A Study of RO5093151 in Patients With Ocular Hypertension Or Open Angle Glaucoma

This randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and the effect of RO5093151 on intraocular pressure in patients with ocular hypertension or open angle glaucoma. Patients will be randomized to receive oral doses of RO5093151 or placebo twice daily. The anticipated time on study treatment is 7 days with the possibility to extend to 28 days.

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Key information

Conditions

Hypertension, Glaucoma, Open-Angle Cardiovascular Diseases Eye Diseases Glaucoma Hypertension Ocular Hypertension Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sofia, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients, at least 21 years of age, inclusive
  • Diagnosis of ocular hypertension or primary open angle glaucoma in at least one eye
  • Able to participate and willing to give informed consent

Exclusion criteria

  • Presence of extreme narrow angle with complete or partial closure
  • Progressive retinal or optic nerve disease from any cause other than glaucoma
  • History or signs of penetrating ocular trauma
  • Uncontrolled hypertension
  • Clinically significant abnormalities in laboratory test results
  • Positive test results on hepatitis B, hepatitis C, or HIV 1 and 2
  • Kidney disease or dysfunction

Treatment and study plan

Placebo

Drug

Placebo to RO5093151

RO5093151

Drug

oral doses twice daily for up to 28 days

Primary outcomes

  1. Change in mean intraocular pressure (IOP) at 1 hour post-dose following 7 days of treatment

    Time frame: Day 7

Secondary outcomes

  1. Change in mean daily intraocular pressure (IOP)

    Time frame: Up to 28 days

  2. Change in mean intraocular pressure (IOP) at each assessment time-points

    Time frame: Up to 28 days

  3. Change in intraocular pressure (IOP) during a placebo lead-in phase

    Time frame: 7 days

  4. Pharmacokinetics (area under the concentration time curve)

    Time frame: Day 7

  5. Urinary ratio of tetrahydrocortisol to tetrahydrocortisone

    Time frame: 7 days

  6. Safety (incidence of adverse events)

    Time frame: Up to 28 days

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Adaptive, Multi-center, Randomized, Investigator-masked, Subject-masked, Multiple-dose, Placebo-controlled, Parallel Study to Investigate Efficacy, Safety, Tolerability and Pharmacokinetics of RO5093151 for up to 28 Days in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 15, 2011
Registry last updated
Nov 2, 2016

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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