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

NCT00698724 | Completed Phase 4

• 1 other identifier: 5359
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataracts

Outcome Measures

Primary Outcomes (1)

• OCT

  2-4 months

Secondary Outcomes (1)

• Visual Acuity

  2-4 months

Study Arms (2)

1

ACTIVE COMPARATOR

Group 1: Xibrom, Optive

Drug: Xibrom, and Optive

2

ACTIVE COMPARATOR

Group 2: Xibrom, Pred Forte

Drug: Xibrom and Pred Forte

Interventions

Xibrom, and Optive DRUG

Xibrom: two drops a day, three days before surgery and 21 days after surgery. Optive: three times a day for 21 days after surgery.

1

Xibrom and Pred Forte DRUG

Xibrom: two drops a day, three days before surgery and 21 days after surgery. Pred Forte: three times a day for 21 days after surgery.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bp Consulting, Inc: lead

Study Sites (1)

St. Luke's Cataract and Laser institute

Tarpon Springs, Florida, 34688, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

bromfenac; prednisolone acetate

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• James Gills, MD

  St. Luke's Cataract and Laser Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: June 13, 2008
• First Posted: June 17, 2008
• Study Start: June 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: June 10, 2009

Record last verified: 2009-06

Locations

US (1)