Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery

Safety and Efficacy of Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery

Evaluation of the clinical safety and efficacy of loteprednol etabonate in an ophthalmic base, when compared to vehicle for the treatment of inflammation following cataract surgery.

Study Overview

• Status: Completed
• Conditions: Ocular Inflammation
• Intervention / Treatment: Drug: Loteprednol Etabonate; Drug: Vehicle of Ophthalmic Loteprednol Etabonate

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Cornerstone Eye Wear

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects at least 18 years of age
• Subjects who have the ability to understand and sign an informed consent form and provide Health Insurance Portability and Accountability Act (HIPAA) authorization.
• Subjects who are candidate for routine, uncomplicated cataract surgery.
• Subjects who are not of childbearing potential or subjects who have a negative urine pregnancy test result at screening.
• Subjects must be willing and able to comply with all treatment and follow- up procedures.

Exclusion Criteria:

• Subjects who have known hypersensitivity or contraindication to the study drug or its components.
• Subjects who have a history or presence of chronic generalized systemic disease that the investigator feels might increase the risk to the subject or compound the result of the study.
• Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up.
• Subjects with elevated intraocular pressure (>/= 21 mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.
• Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye.
• Subjects who have had ocular surgery in the study eye within 3 months or in the fellow eye within 2 weeks prior to the screening visit.
• Women who are pregnant or breast feeding.
• Subjects who have participated in an investigational drug or device study within the last 30 days.
• Subjects previously randomized in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Loteprednol Etabonate; Loteprednol Etabonate 0.5%	Drug: Loteprednol Etabonate; Loteprednol Etabonate in an ophthalmic base will be administered to study eye 4 times a day(QID) for 14 days.
Placebo Comparator: Vehicle; Vehicle of Ophthalmic Loteprednol Etabonate	Drug: Vehicle of Ophthalmic Loteprednol Etabonate; Vehicle of ophthalmic loteprednol etabonate administered postoperatively to study eye 4 times a day(QID) for 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0	A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.	Postoperative day 8 (Visit 5)
Participants With Grade 0 (no) Pain	Pain: A positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. Grade 0 = None; 1=Minimal; 2=Mild; 3=Moderate; 4=Moderately Severe; 5=Severe	Postoperative day 8 (Visit 5)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit.	A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.	At each visit: Visit 4-7, postoperative days 3-18
Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare	A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.	Postoperative Day 3-18 (Each follow-up Visit 4-7)

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Laura Trusso, Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: June 13, 2008
• First Submitted That Met QC Criteria: June 16, 2008
• First Posted (Estimate): June 17, 2008

Study Record Updates

• Last Update Posted (Estimate): March 24, 2015
• Last Update Submitted That Met QC Criteria: March 4, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Lens Diseases; Inflammation; Cataract; Anti-Allergic Agents; Loteprednol Etabonate
• Other Study ID Numbers: 526