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

Phase 1

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: LE Gel

• Registration Number: NCT01736527
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2012-11-27
• Study First Submitted QC: 2012-11-28
• Study First Posted: 2012-11-29
• Study Start: 2013-01
• Primary Completion: 2013-01
• Study Completion: 2013-04
• Status Verified: 2013-08
• Results First Submitted: 2013-08-27
• Results First Submitted QC: 2013-08-27
• Last Update Submitted: 2013-08-27
• Results First Posted: 2013-11-08
• Last Update Posted: 2013-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LE Gel	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.

Primary Outcome Measures

Name	Time	Method
Tear Fluid Levels	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

Trial Locations

Locations (1)

Bausch & Lomb Research Clinic; 🇺🇸 Rochester, New York, United States