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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01736527
First received: November 27, 2012
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Pharmacokinetics
Drug: LE Gel
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official 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

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Tear Fluid Levels [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    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

  • Tear Fluid Levels [ Time Frame: 9 hours ] [ Designated as safety issue: No ]
    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

  • Tear Fluid Levels [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    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

  • Tear Fluid Levels [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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


Enrollment: 12
Study Start Date: January 2013
Study Completion Date: April 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LE Gel
A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.
Drug: LE Gel
Single drop of LE Gel 0.5% administered to the study eye on visit 2
Other Name: Lotemax

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01736527

Locations
United States, New York
Bausch & Lomb Research Clinic
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Principal Investigator: Jeffery Schafer, OD, MS Bausch & Lomb Incorporated
Study Director: Raphaele Siou Mermet, MD, MS Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01736527     History of Changes
Other Study ID Numbers: 808
Study First Received: November 27, 2012
Results First Received: August 27, 2013
Last Updated: August 27, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Loteprednol etabonate
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 02, 2014