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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00645671
First received: March 13, 2008
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

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


Condition Intervention Phase
Ocular Inflammation
Drug: 0.5% Loteprednol Etabonate Ophthalmic Ointment
Drug: Vehicle of Loteprednol Etabonate Ophthalmic Ointment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Multicenter, Double-Masked, Parallel-Group Clinical Safety and Efficacy Evaluation of Loteprednol Etabonate Ophthalmic Ointment, 0.5% Versus Vehicle for the Treatment of Inflammation Following Cataract Surgery

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Subjects With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0. [ Time Frame: Postoperative Day 8 (Visit 5) ] [ Designated as safety issue: No ]
    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.

  • Grade 0 for Pain [ Time Frame: Postoperative Day 8 (Visit 5) ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit. [ Time Frame: At each follow-up visit through day18 (Visit 7) ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare [ Time Frame: Baseline and each follow-up visit through day18 (Visit 7) ] [ Designated as safety issue: No ]
    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.


Enrollment: 400
Study Start Date: March 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Loteprednol Etabonate
Loteprednol etabonate 0.5% ophthalmic ointment
Drug: 0.5% Loteprednol Etabonate Ophthalmic Ointment
1/2 inch ribbon four times a day for 14 days
Placebo Comparator: Vehicle
Vehicle of loteprednol etabonate ointment
Drug: Vehicle of Loteprednol Etabonate Ophthalmic Ointment
1/2 inch ribbon four times a day for 14 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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
  2. Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components
  3. Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye
  4. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645671

Locations
United States, Kansas
John Hunkeler, MD
Overland Park, Kansas, United States, 66210
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Alyson J Berliner, MD/PhD Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00645671     History of Changes
Other Study ID Numbers: 525
Study First Received: March 13, 2008
Results First Received: June 28, 2010
Last Updated: December 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Inflammation
Cataract
Pathologic Processes
Lens Diseases
Eye Diseases
Loteprednol etabonate
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014