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Corticosteroid
Randomized, Masked Comparison of Bromfenac and Besifloxacin BID With Either Prednisolone BID or Loteprednol 0.5% BID for Prevention of Retinal Thickening and CME Following Phacoemulsification
Phase 4
Waitlist Available
Led By Bonnie Henderson, MD
Research Sponsored by Innovative Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
All Individual Drugs Already Approved
Summary
The purpose of this study is to determine if Lotemax eye drops are at least as effective as Pred Forte eye drops, which are the standard of care after cataract surgery.
Eligible Conditions
- Pseudophakia
- Cataract Surgery
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Prevention Of Retinal Thickening
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Active Control
Group I: Pred ForteActive Control1 Intervention
Patients scheduled to undergo phacoemulsification will be randomized in a 1:1 schedule to receive Pred Forte BID for 4 weeks postop. All patients will receive Xibrom BID for one month and Besifloxacin BID for 7 to 10 days postop.
Group II: LotemaxActive Control1 Intervention
patients scheduled to undergo phacoemulsification will be randomized in a 1:1 schedule to receive Lotemax BID for 4 weeks postop. All patients will receive Xibrom BID for one month and Besifloxacin BID for 7 to 10 days postop.
Find a Location
Who is running the clinical trial?
Innovative MedicalLead Sponsor
51 Previous Clinical Trials
2,528 Total Patients Enrolled
1 Trials studying Pseudophakia
30 Patients Enrolled for Pseudophakia
Bonnie Henderson, MDPrincipal InvestigatorOphthalmic Consultants of Boston
William Trattler, MDPrincipal InvestigatorThe Center for Excellence in Eye Care
11 Previous Clinical Trials
6,499 Total Patients Enrolled
1 Trials studying Pseudophakia
30 Patients Enrolled for Pseudophakia
John Hovanesian, MDPrincipal InvestigatorHarvard Eye Associates
13 Previous Clinical Trials
4,435 Total Patients Enrolled