Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery

NCT00645671 | Completed Phase 3 Results

• 1 other identifier: 525
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the clinical safety and efficacy of Loteprednol Etabonate Ophthalmic Ointment, 0.5% vs. vehicle for the treatment of inflammation following cataract surgery

Conditions

Ocular Inflammation

Outcome Measures

Primary Outcomes (2)

• Subjects 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)

• Grade 0 for 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)

• Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit.

  At each follow-up visit through day18 (Visit 7)

• Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare

  Baseline and each follow-up visit through day18 (Visit 7)

Study Arms (2)

Loteprednol Etabonate

EXPERIMENTAL

Loteprednol etabonate 0.5% ophthalmic ointment

Drug: 0.5% Loteprednol Etabonate Ophthalmic Ointment

Vehicle

PLACEBO COMPARATOR

Vehicle of loteprednol etabonate ointment

Drug: Vehicle of Loteprednol Etabonate Ophthalmic Ointment

Interventions

0.5% Loteprednol Etabonate Ophthalmic Ointment DRUG

1/2 inch ribbon four times a day for 14 days

Loteprednol Etabonate

Vehicle of Loteprednol Etabonate Ophthalmic Ointment DRUG

1/2 inch ribbon four times a day 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 who are candidate for routine, uncomplicated cataract surgery
• Subjects who, in the Investigator's opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye.

You may not qualify if:

• Subjects who will require concurrent ocular therapy with NSAIDs, mast cell stabilizers, antihistamines, decongestants, or immunosuppressants (e.g., Restasis), or with ocular or systemic corticosteroids
• Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components
• Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye
• Subjects who have had ocular surgery (including laser surgery) in the study eye within 3 months or in the fellow eye within 2 weeks prior to the Screening Visit

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

John Hunkeler, MD

Overland Park, Kansas, 66210, United States

Location

Results Point of Contact

• Title: Dr. Tuyen Ong
• Organization: Bausch & Lomb

Tuyen.Ong@bausch.com

(973) 360-6389

Study Officials

• Alyson J Berliner, MD/PhD

  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: March 13, 2008
• First Posted: March 28, 2008
• Study Start: March 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: March 24, 2015
• Results First Posted: September 23, 2010

Record last verified: 2015-03

Locations

US (1)