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OpenTrials
Completed

NCT Number: NCT01736527

Tear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% Following a Single Instillation

To assess the levels of loteprednol etabonate (LE) in tear fluid following a single topical instillation of LE ophthalmic gel 0.5% formulation to healthy volunteers.

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Key information

Conditions

Pharmacokinetics

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bausch & Lomb Research Clinic

Rochester, New York, 14609, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects must be healthy volunteers with physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
  • Subjects must have a best-corrected visual acuity of 20/20 or better in each eye.
  • Subjects must have no active ocular disease or allergic conjunctivitis.
  • Subjects must have a Schirmer test (without anesthesia) of ≥ 10mm in 5 minutes.
  • Subjects must not be using any topical ocular medications or systemic medication other than acetaminophen.
  • Male subjects or female subjects who are not of childbearing potential. Female subjects are considered to not be of childbearing potential if they are postmenopausal for at least 12 months or permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy)

Exclusion criteria

  • Subjects having an intraocular pressure less than 5 mmHg or greater than 22 mmHg or any type of glaucoma.
  • Subjects with a history of ocular trauma, infection, or inflammation within the last 3 months.
  • Subjects having any contraindication to the use of, or known sensitivity or allergy to, the study drug(s) or their components.
  • Subjects wearing contact lenses on the day of Visit 2 and/or Visit 3 of the study
  • Subjects having, at the Investigator's discretion, the presence of any significant illness that could be expected to interfere with the study.

Treatment and study plan

LE Gel

Drug

Single drop of LE Gel 0.5% administered to the study eye on visit 2

Other names: Lotemax

Primary outcomes

  1. Tear Fluid Levels

    Time frame: 6 hours

    Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose

  2. Tear Fluid Levels

    Time frame: 9 hours

    Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose

  3. Tear Fluid Levels

    Time frame: 12 hours

    Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose

  4. Tear Fluid Levels

    Time frame: 24 hours

    Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

Tear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% at 6, 9, 12, and 24 Hours Following a Single Instillation in Healthy Volunteers

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 29, 2012
Registry last updated
Nov 8, 2013

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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