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OpenTrials
Completed

NCT Number: NCT00698724

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

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.

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Key information

Conditions

Cataracts Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Luke's Cataract and Laser institute

Tarpon Springs, Florida, 34688, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. OCT

    Time frame: 2-4 months

Secondary outcomes

  1. Visual Acuity

    Time frame: 2-4 months

Sponsors and collaborators

Lead sponsor

Bp Consulting, Inc

Network

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 17, 2008
Registry last updated
Jun 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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