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 Standard Presurgical Care

Phase 4

Completed

• Conditions: Cataracts
• Interventions: Drug: Xibrom, and Optive; Drug: Xibrom and Pred Forte

• Registration Number: NCT00698724
• Lead Sponsor: Bp Consulting, Inc

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-13
• Study First Submitted QC: 2008-06-16
• Study First Posted: 2008-06-17
• Status Verified: 2009-06
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Last Update Submitted: 2009-06-08
• Last Update Posted: 2009-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Xibrom, and Optive	Group 1: Xibrom, Optive
2	Xibrom and Pred Forte	Group 2: Xibrom, Pred Forte

Primary Outcome Measures

Name	Time	Method
OCT	2-4 months

Secondary Outcome Measures

Name	Time	Method
Visual Acuity	2-4 months

Trial Locations

Locations (1)

St. Luke's Cataract and Laser institute; 🇺🇸 Tarpon Springs, Florida, United States