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

Pharmacokinetics Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01736527
• Other study ID #: 808
• Status: Completed
• Phase: Phase 1
• First received: November 27, 2012
• Last updated: August 27, 2013
• Start date: January 2013
• Est. completion date: April 2013

Study information

• Verified date: August 2013
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

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

Locations

Country	Name	City	State
United States	Bausch & Lomb Research Clinic	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear Fluid Levels	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	6 hours	No
Primary	Tear Fluid Levels	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	9 hours	No
Primary	Tear Fluid Levels	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	12 hours	No
Primary	Tear Fluid Levels	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	24 hours	No