Comparing Optical Coherence Tomography (OCT) and Visual Acuity Outcomes in Subjects Undergoing Cataract Surgery, Who Receive Xibrom Ophthalmic Solution and Standard Presurgical Care vs. Xibrom Ophthalmic Solution Plus Prednisolone Acetate 1% and Sta

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the efficacy of twice-daily topical bromfenac (Xibrom) ophthalmic solution alone versus twice-daily topical Xibrom with prednisolone acetate 1% three-times daily on visual acuity and OCT measurements.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bp Consulting, Inc
• Treatments: Bromfenac; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Ophthalmic Solutions; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Male or female at least 18 years of age.

• Expectation of 20/25 best corrected visual acuity (BCVA) post-operatively.

• Patients should be in good general health and devoid of recognized risk factors for CME.

• Patients with systemic diseases are eligible only if there were no ocular manifestations of the disease (specifically diabetics without retinopathy)

• Patients must be likely to provide informed consent, take study medications as directed, and complete all study visits

• Only one eye of each treated patient may be included in the study

Exclusion Criteria:

• Any known contraindications to any study medication or their component

• Presence of uncontrolled systemic disease

• Required use of other ocular medications during the study

o Artificial tears may be used

• Diabetics with any clinically evident or history of retinopathy

• Individuals with age-related macular changes, epi-retinal membranes, other retino-vascular diseases and/or other macular disorders thought to have a less than 20/25 surgical outcome expectation

• Abnormal pre-operative OCT (if obtainable)