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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00698724

Enrollment

200

Registered

2008-06-17

Start date

2008-06-30

Completion date

2009-06-30

Last updated

2009-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataracts

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.

Interventions

DRUGXibrom, 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.

DRUGXibrom 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
OCT	2-4 months

Secondary

Measure	Time frame
Visual Acuity	2-4 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026