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

Ocular Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00699153
• Other study ID #: 526
• Status: Completed
• Phase: Phase 3
• First received: June 13, 2008
• Last updated: March 4, 2015
• Start date: June 2008
• Est. completion date: June 2009

Study information

• Verified date: March 2015
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation
• Ocular Inflammation

Intervention

Drug:
• Loteprednol Etabonate
Loteprednol Etabonate in an ophthalmic base will be administered to study eye 4 times a day(QID) for 14 days.
• Vehicle of Ophthalmic Loteprednol Etabonate
Vehicle of ophthalmic loteprednol etabonate administered postoperatively to study eye 4 times a day(QID) for 14 days.

Locations

Country	Name	City	State
United States	Cornerstone Eye Wear	High Point	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants 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)	No
Primary	Participants With Grade 0 (no) 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)	No
Secondary	Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit.	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.	At each visit: Visit 4-7, postoperative days 3-18	No
Secondary	Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare	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 3-18 (Each follow-up Visit 4-7)	No