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
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| ClinicalTrials.gov Identifier: NCT01193504 |
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Recruitment Status : Unknown
Verified June 2012 by Innovative Medical.
Recruitment status was: Recruiting
First Posted : September 2, 2010
Last Update Posted : June 14, 2012
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Sponsor:
Innovative Medical
Information provided by:
Innovative Medical
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pseudophakia Cataract Surgery | Drug: Pred Forte Drug: Lotemax | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (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 |
| Study Start Date : | September 2010 |
| Estimated Primary Completion Date : | October 2012 |
| Estimated Study Completion Date : | October 2012 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Cataract
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Pred Forte
Pred Forte BID for 4 weeks postop |
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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.
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Drug: Lotemax
Lotemax BID for 4 weeks postop. |
Primary Outcome Measures :
- Prevention Of Retinal Thickening [ Time Frame: 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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| Responsible Party: | Dr. William Trattler, The Center for Excellence in Eye care |
| ClinicalTrials.gov Identifier: | NCT01193504 History of Changes |
| Other Study ID Numbers: |
25324 |
| First Posted: | September 2, 2010 Key Record Dates |
| Last Update Posted: | June 14, 2012 |
| Last Verified: | June 2012 |
Keywords provided by Innovative Medical:
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Prevention of Retinal Thickening and CME Following Phacoemulsification Pseudophakia following cataract surgery |
Additional relevant MeSH terms:
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Cataract Pseudophakia Lens Diseases Eye Diseases Signs and Symptoms Loteprednol Etabonate Besifloxacin Prednisolone Methylprednisolone Acetate Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone acetate Bromfenac Prednisolone hemisuccinate Prednisolone phosphate |
Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents Anti-Allergic Agents Anti-Inflammatory Agents, Non-Steroidal |