A Phase 4 interventional study of Pred Forte and Lotemax in Pseudophakia and Cataract Surgery, sponsored by Innovative Medical. Status unknown at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-06-14.
Sponsored by Innovative Medical · Phase 4, Interventional, and Prevention
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.
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.
54 studies on the registry are indexed under Pseudophakia; 8 are open to participants now.
This study's planned enrollment of 100 is above the median of 45 across 25 interventional studies indexed under Pseudophakia.
Browse Pseudophakia studies →Innovative Medical is the lead sponsor of 51 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Pred Forte BID for 4 weeks postop
Lotemax BID for 4 weeks postop.
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
Time frame: 1 Year
This study is status unknown, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Prednisolone acetate · Loteprednol Etabonate