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

Cataracts Clinical Trial

Official title:

A Prospective, Randomized Single-Masked Clinical Trial Comparing 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00698724
• Other study ID #: 5359
• Status: Completed
• Phase: Phase 4
• First received: June 13, 2008
• Last updated: June 8, 2009
• Start date: June 2008
• Est. completion date: June 2009

Study information

• Verified date: June 2009
• Source: Bp Consulting, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Cataracts

Intervention

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

Locations

Country	Name	City	State
United States	St. Luke's Cataract and Laser institute	Tarpon Springs	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bp Consulting, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OCT		2-4 months	No
Secondary	Visual Acuity		2-4 months	No