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

NCT ID: NCT01736527

Last Updated: 2013-11-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pharmacokinetics

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

LE Gel

Intervention Type DRUG

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

Interventions

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LE Gel

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

Intervention Type DRUG

Other Intervention Names

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Lotemax

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffery Schafer, OD, MS

Role: PRINCIPAL_INVESTIGATOR

Bausch & Lomb Incorporated

Raphaele Siou Mermet, MD, MS

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

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Bausch & Lomb Research Clinic

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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808

Identifier Type: -

Identifier Source: org_study_id