PseudophakiaPhase 4NCT01193504
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
A Phase 4 study testing Pred Forte and Lotemax in people with Pseudophakia and Cataract Surgery, run by Innovative Medical at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pseudophakia, Cataract Surgery
- What is being tested?
- Pred Forte and Lotemax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2010to Oct 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 2 recruiting
- Recruiting
Harvard Eye Associates
Laguna Hills, California, 92653
Melissa Earl, 951-653-5566, m.earl@imedsonline.com
Annie Christensen, (951)653-5566, a.christensen@imedsonline.com
- Recruiting
The Center For Excellence in Eye care
Miami, Florida, 33176
Melissa Earl, 951-653-5566, m.earl@imedsonline.com
Annie Christensen, (951)653-5566, a.christensen@imedsonline.com
- Completed
Ophthalmic Consultants of Boston
Waltham, Massachusetts, 02451
About this study
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.
Read the 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.
- Conditions
- Pseudophakia, Cataract Surgery
- Being tested
- Pred Forte, Lotemax
- Keywords
- Prevention of Retinal Thickening and CME Following Phacoemulsification, Pseudophakia following cataract surgery
- Medical subject headings
- Pseudophakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pred ForteDrug
Pred Forte BID for 4 weeks postop
LotemaxDrug
Lotemax BID for 4 weeks postop.
| Study group | Role | What they receive |
|---|---|---|
| Pred Forte | Active comparator | 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. Receives: Drug: Pred Forte |
| Lotemax | Active comparator | 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. Receives: Drug: Lotemax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention Of Retinal Thickening
- 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
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PseudophakiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovative Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- William Trattler, MD, Principal investigator, The Center for Excellence in Eye CareJohn Hovanesian, MD, Principal investigator, Harvard Eye AssociatesBonnie Henderson, MD, Principal investigator, Ophthalmic Consultants of Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01193504
- Sponsor's protocol ID
- 25324
- Status last verified
- Jun 2012
- First submitted
- 31 Aug 2010
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01193504
- Acronym / sponsor ID
- 25324
- Conditions
- Pseudophakia, Cataract Surgery
- Keywords
- Prevention of Retinal Thickening and CME Following Phacoemulsification, Pseudophakia following cataract surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Innovative MedicalIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 2 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pred Forte | Active comparator | Drug: Pred FortePatients 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. |
| Lotemax | Active comparator | Drug: Lotemaxpatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pred FortePred Forte BID for 4 weeks postop | Drug | Pred Forte |
| LotemaxLotemax BID for 4 weeks postop. | Drug | Lotemax |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2012.
Related trials for Pseudophakia
RecruitingObservational study
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IOL Position and Refractive Change After Nd:YAG Laser Posterior Capsulotomy
Posterior Capsule Opacification, Pseudophakia
Enrolling by invitation
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Treatment of Residual Refraction Errors 6 Months After Trifocal IOL Implantation With Relex-Smile
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Active, not recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Trattler, MD principal investigator
The Center for Excellence in Eye Care
John Hovanesian, MD principal investigator
Harvard Eye Associates
Bonnie Henderson, MD principal investigator
Ophthalmic Consultants of Boston
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pred Forte and Lotemax in people with Pseudophakia and Cataract Surgery, run by Innovative Medical at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jenna Piel ((951)653-5566, j.piel@imedsonline.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention Of Retinal Thickening (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2012.