Clinical Outcomes and Evaluation of Lotemax 0.5% in Treatment of Ocular Inflammation Associated With Cataract Surgery

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Investigate the intraocular pressure(pressure inside the eye) of patients who are treated with Lotemax after undergoing cataract surgery.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Discover Vision Centers; Toyos Clinic
• Treatments: Loteprednol Etabonate; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

1. Male or Female 18 years of age scheduled for unilateral cataract surgery (phacoemulsification or extracapsular) with posterior chamber intraocular lens implantation.

2. Agree not to have any other ocular surgery in the study or fellow eye for duration of study.

3. Have a BCVA of 20/200 or better in either eye.

4. Willing/able to return for all required study visits.

5. Willing/able to follow instructions from the study investigator and their staff.

6. Able to self-administer test article (or have a caregiver available to instill all doses of test article).

7. If woman capable of becoming pregnant, agree to have urine pregnancy test(must be negative) at agree to use a medically acceptable form of birth control during study and for at least one week prior to and after completion of the study.

8. Have read, understood, and signed the informed consent document approved by Sterling Institutional Review Board.

9. Have IOP ≥ 5mmHg and ≤ 22mmHg, (in study eye) with or without anti-glaucoma therapy at the pre-operative screening visit (if > 22mmHg, adjust following pachymetry).

Exclusion Criteria:

1. Have known hypersensitivity to Lotemax or to any component of the test article (including "procedural" medications such as anesthetic and/or fluorescein drops, dilating drops, etc.).

2. Have a known hypersensitivity to non-steroidal or steroidal anti-inflammatory drugs (NSAIDs).

3. Have intraocular inflammation (i.e. cells or flare in the anterior chamber as measured on slit lamp exam) in the study eye at the screening visit.

4. Have a known blood dyscrasia or bone marrow suppression, a diagnosis of uncontrolled/unstable peptic ulcer disease, inflammatory bowel disease, or ulcerative colitis, or any uncontrolled/unstable pulmonary, cardiac, vascular, autoimmune, hepatic, renal, or central nervous system disease.

5. Have used ocular, topical, or systemic steroids within 14 days or depot steroid 30 days prior to initiation of dosing with the test article or throughout the duration of the study. Note: use of an opioid during surgery (e.g., fentanyl) is allowed.

6. Have uncontrolled glaucoma or IOP >/= 27mmHg.

7. Have active corneal pathology noted in the study eye at the screening visit. Active corneal pathology is defined as corneal pathology that is non-stable, or greater than mild, or will compromise assessment of the safety or efficacy of treatment.

8. Are pregnant or nursing.

9. Have participated in any other study of an investigational drug or device within 30 days prior to randomization.