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

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ClinicalTrials.gov Identifier: NCT00645671
Recruitment Status : Completed
First Posted : March 28, 2008
Results First Posted : September 23, 2010
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Description
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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

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Subjects With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0. [ Time Frame: Postoperative Day 8 (Visit 5) ]
    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.

  2. Grade 0 for Pain [ Time Frame: Postoperative Day 8 (Visit 5) ]
    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 :
  1. 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) ]
    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.

  2. 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) ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00645671


Locations
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United States, Kansas
John Hunkeler, MD
Overland Park, Kansas, United States, 66210
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
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Study Director: Alyson J Berliner, MD/PhD Bausch & Lomb Incorporated
More Information
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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00645671    
Other Study ID Numbers: 525
First Posted: March 28, 2008    Key Record Dates
Results First Posted: September 23, 2010
Last Update Posted: March 24, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Cataract
Inflammation
Pathologic Processes
Lens Diseases
 Eye Diseases
Loteprednol Etabonate
Anti-Allergic Agents