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
This study is currently recruiting participants.
Verified June 2012 by Innovative Medical
Sponsor:
Innovative Medical
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT01193504
First received: August 31, 2010
Last updated: June 13, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pseudophakia Cataract Surgery |
Drug: Pred Forte Drug: Lotemax |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
| Official Title: | 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Cataract
Drug Information available for:
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone sodium phosphate
Prednisolone phosphate
Prednisolone sodium succinate
Methylprednisolone sodium succinate
Loteprednol etabonate
Bromfenac sodium
Bromfenac
Besifloxacin
U.S. FDA Resources
Further study details as provided by Innovative Medical:
Primary Outcome Measures:
- Prevention Of Retinal Thickening [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
- 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
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Pred Forte
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.
|
Drug: Pred Forte
Pred Forte BID for 4 weeks postop
|
|
Active Comparator: Lotemax
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.
|
Drug: Lotemax
Lotemax BID for 4 weeks postop.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193504
Contacts
| Contact: Jenna Piel | (951)653-5566 | j.piel@imedsonline.com |
Locations
| United States, California | |
| Harvard Eye Associates | Recruiting |
| Laguna Hills, California, United States, 92653 | |
| Contact: Melissa Earl 951-653-5566 m.earl@imedsonline.com | |
| Contact: Annie Christensen (951)653-5566 a.christensen@imedsonline.com | |
| Principal Investigator: John Hovanesian, MD | |
| United States, Florida | |
| The Center For Excellence in Eye care | Recruiting |
| Miami, Florida, United States, 33176 | |
| Contact: Melissa Earl 951-653-5566 m.earl@imedsonline.com | |
| Contact: Annie Christensen (951)653-5566 a.christensen@imedsonline.com | |
| Principal Investigator: William Trattler, MD | |
| Sub-Investigator: Carlos Buznego, MD | |
| United States, Massachusetts | |
| Ophthalmic Consultants of Boston | Completed |
| Waltham, Massachusetts, United States, 02451 | |
Sponsors and Collaborators
Innovative Medical
Investigators
| Principal Investigator: | William Trattler, MD | The Center for Excellence in Eye Care |
| Principal Investigator: | John Hovanesian, MD | Harvard Eye Associates |
| Principal Investigator: | Bonnie Henderson, MD | Ophthalmic Consultants of Boston |
More Information
No publications provided
| Responsible Party: | Dr. William Trattler, The Center for Excellence in Eye care |
| ClinicalTrials.gov Identifier: | NCT01193504 History of Changes |
| Other Study ID Numbers: | 25324 |
| Study First Received: | August 31, 2010 |
| Last Updated: | June 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Innovative Medical:
|
Prevention of Retinal Thickening and CME Following Phacoemulsification Pseudophakia following cataract surgery |
Additional relevant MeSH terms:
|
Pseudophakia Cataract Signs and Symptoms Lens Diseases Eye Diseases Methylprednisolone acetate Prednisolone acetate Bromfenac Prednisolone Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone hemisuccinate Prednisolone phosphate Loteprednol etabonate Anti-Inflammatory Agents |
Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents |
ClinicalTrials.gov processed this record on May 22, 2013