Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery

NCT00758199 | Completed Phase 4

• 1 other identifier: 2008-0036
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine if an extension of bromfenac BID monotherapy is effective in the decreasing retinal thickening post cataract IOL placement surgery. No studies exist on how long to treat with an NSAID post cataract IOL placement surgery. Currently, NSAID therapy post IOL placement surgery is in conjunction with steroid treatment, lasting approximately 3 weeks. This study is designed to examine if there is benefit to extending NSAID monotherapy in regards to macular thickening and the incidence of CME.

Conditions

Cataracts

Outcome Measures

Primary Outcomes (1)

• OCT with macular thickening

  3-6 weeks

Secondary Outcomes (1)

• Incidence of CME

  3-6 weeks

Study Arms (3)

2

ACTIVE COMPARATOR

Moxifloxacin

Drug: Moxifloxacin hydrochloride

3

PLACEBO COMPARATOR

Prednisolone Acetate

Drug: Prednisolone Acetate

1

ACTIVE COMPARATOR

Bromfenac

Drug: Bromfenac

Interventions

Bromfenac DRUG

Group 1: Bromfenac BID for 3 weeks Group 2: Bromfenac BID for 6 weeks

Also known as: Bromfenac (Xibrom)

1

Moxifloxacin hydrochloride DRUG

Group 1 and Group 2:Moxifloxacin hydrochloride 1 day prior to surgery-continue for six days after surgery.

Also known as: Moxifloxacin hydrochloride (Vigamox)

2

Prednisolone Acetate DRUG

Group 1 and Group 2:Prednisolone Acetate for 3 weeks in a tapering schedule (week 1: TID; week 2: BID, week 3:QD).

Also known as: Omni-Pred

3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female \>18 years of age scheduled to undergo bilateral cataract surgery
• Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (e.g. diabetics with normal retinal exams)
• Expected visual outcome of BCVA \> \[greater than or equal to\] 20/30 postoperatively
• Ability to provide informed consent, take study medications as directed, and likely to complete all study visits

You may not qualify if:

• Known contraindication to any study medication or any of their components
• Required use of ocular medications other than the study medications during the study
• Significant AMD, epi-retinal membrane, retinal vein occlusion, diabetic macular edema, or any macular disease predisposing them to cystoid macular edema.
• Posterior capsule rupture, Vitreous loss during surgery or any other complication that in the surgeon's opinion, could reduce potential for targeted visual outcome
• Anticipated need for mechanical iris dilating devices

Sponsors & Collaborators

• Bp Consulting, Inc: lead

Study Sites (1)

Altos Eye Physicians

Los Altos, California, 94024, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

bromfenac; Moxifloxacin; prednisolone acetate

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: September 22, 2008
• First Posted: September 25, 2008
• Study Start: July 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: March 15, 2012

Record last verified: 2012-03

Locations

US (1)