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

NCT00699153 | Completed Phase 3 Results

• 1 other identifier: 526
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ocular Inflammation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit.

  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

  Postoperative Day 3-18 (Each follow-up Visit 4-7)

Study Arms (2)

Loteprednol Etabonate

EXPERIMENTAL

Loteprednol Etabonate 0.5%

Drug: Loteprednol Etabonate

Vehicle

PLACEBO COMPARATOR

Vehicle of Ophthalmic Loteprednol Etabonate

Drug: Vehicle of Ophthalmic Loteprednol Etabonate

Interventions

Loteprednol Etabonate DRUG

Loteprednol Etabonate in an ophthalmic base will be administered to study eye 4 times a day(QID) for 14 days.

Loteprednol Etabonate

Vehicle of Ophthalmic Loteprednol Etabonate DRUG

Vehicle of ophthalmic loteprednol etabonate administered postoperatively to study eye 4 times a day(QID) for 14 days.

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Cornerstone Eye Wear

High Point, North Carolina, 27262, United States

Location

MeSH Terms

Interventions

Loteprednol Etabonate

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Laura Trusso, MS.
• Organization: Bausch & Lomb, Inc.

laura.trusso@bausch.com

(585) 338-5561

Study Officials

• Laura Trusso

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2008
• First Posted: June 17, 2008
• Study Start: June 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: June 1, 2009
• Last Updated: March 24, 2015
• Results First Posted: September 23, 2010

Record last verified: 2015-03

Locations

US (1)