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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01193504

Enrollment

100

Registered

2010-09-02

Start date

2010-09-30

Completion date

2012-10-31

Last updated

2012-06-14

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

Conditions

Pseudophakia, Cataract Surgery

Keywords

Prevention of Retinal Thickening and CME Following Phacoemulsification, Pseudophakia following cataract surgery

Brief 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.

Detailed description

Prednisolone 1%, a topical steroid, is considered standard of care following cataract surgery to reduce inflammation. We aim to determine if Lotemax is at least as effective as Prednisolone. If so, these findings would demonstrate that physicians have other treatment options to consider.

Interventions

DRUGPred Forte

Pred Forte BID for 4 weeks postop

DRUGLotemax

Lotemax BID for 4 weeks postop.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Male or female \>18 years of age scheduled to undergo 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 (best corrected visual acuity)\> 20/25 postoperatively, as determined by potential visual acuity testing and review of preoperative corneal topography and OCT (optical coherence tomography). * Ability to provide informed consent, take study medications as directed, and likely to complete all study visits

Exclusion criteria

* Known contraindication to any study medication or any of their components * Required use of ocular medications other than the study medications during the study * Evidence of macular disease (Epiretinal membrane, Vitreomacular traction syndrome, macular hole) on preoperative OCT (optical coherence tomography) * Presence of significant dry macular degeneration that may impact postoperative visual results. * History of retinal vein occlusion or diabetic macular edema, uveitis or any macular disease predisposing them to cystoid macular edema or prolonged intraocular inflammation. * 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 * Presence of Epithelial Basement Membrane Dystrophy, significant dry eye, significant blepharitis, or any other corneal condition that may impact BCVA (best corrected visual acuity) postoperatively

Design outcomes

Primary

Measure	Time frame	Description
Prevention Of Retinal Thickening	1 Year	* OCT (optical coherence tomography) with macular thickening * Incidence of CME ( cystoids macular edema) * BCVA (best corrected visual acuity) * UCVA (uncorrected visual acuity) * Central corneal thickness

Countries

United States

Contacts

Primary ContactJenna Piel

j.piel@imedsonline.com(951)653-5566

Outcome results

None listed

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