Clinical trial NCT00699153: Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery
Official title: Safety and Efficacy of Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ocular Inflammation
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2008-06-17
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0
timeFrame: Postoperative day 8 (Visit 5)
measure: Participants With Grade 0 (no) Pain
timeFrame: Postoperative day 8 (Visit 5)
Secondary outcomes:
measure: Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit.
timeFrame: At each visit: Visit 4-7, postoperative days 3-18
measure: Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare
timeFrame: Postoperative Day 3-18 (Each follow-up Visit 4-7)
Other outcomes:
Locations:
city: High Point
country: United States
facility: Cornerstone Eye Wear
state: North Carolina
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Laura Trusso
role: STUDY_DIRECTOR
References: