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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00699153
First received: June 13, 2008
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Ocular Inflammation
Drug: Loteprednol Etabonate
Drug: Vehicle of Ophthalmic Loteprednol Etabonate
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: Safety and Efficacy of Loteprednol Etabonate in an Ophthalmic Base vs 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:
  • Participants 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.

  • Participants With Grade 0 (no) 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:
  • Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit. [ Time Frame: At each visit: Visit 4-7, postoperative days 3-18 ] [ 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.

  • Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare [ Time Frame: Postoperative Day 3-18 (Each follow-up Visit 4-7) ] [ 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: June 2008
Study Completion Date: June 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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

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.
  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: NCT00699153

Locations
United States, North Carolina
Cornerstone Eye Wear
High Point, North Carolina, United States, 27262
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Laura Trusso Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00699153     History of Changes
Other Study ID Numbers: 526
Study First Received: June 13, 2008
Results First Received: July 9, 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 August 28, 2014