Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery
This study has been completed.
Sponsor:
Bausch & Lomb Incorporated
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
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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:
MedlinePlus related topics:
Cataract
Drug Information available for:
Loteprednol etabonate
U.S. FDA Resources
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:
- 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.
Exclusion Criteria:
- 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
Contacts and Locations
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 June 18, 2013