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41 Diseases |  |
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- || loteprednol etabonate / Generic mfg.
Review, Journal: Loteprednol Etabonate (Submicron) Ophthalmic Gel 0.38%: A Review in Post-Operative Inflammation and Pain Following Ocular Surgery. (Pubmed Central) - Aug 19, 2020
Treatment with loteprednol etabonate gel 0.38% had no meaningful impact on intraocular pressure (IOP) or visual acuity. Thus, loteprednol etabonate gel 0.38% extends the treatment options available in resolving post-operative inflammation and pain in patients who have undergone ocular surgery.
- methotrexate / Generic mfg.
[VIRTUAL] Management of Corneal Epithelial Toxicity Following Intravitreal Methotrexate with Topical Folic Acid Eye Drops in Intraocular Lymphoma (VM) - May 23, 2020 - Abstract #ASCRSASOA2020ASCRS-ASOA_2157;
Conclusion Intravitreal methotrexate can lead to transient limbal stem cell deficiency and epitheliopathy. Topical folic acid is useful in management of such cases especially when the visual axis is involved.
- Eysuvis (loteprednol etabonate nano-suspension 0.25%) / Kala Pharma
[VIRTUAL] Efficacy and Safety of KPI-121 0.25% for Short Term Relief in Dry Eye (STRIDE) (VM) - May 23, 2020 - Abstract #ASCRSASOA2020ASCRS-ASOA_2111;
P2, P3
Conclusion In the completed Phase II and STRIDE 1 trials KPI-121 0.25% improved both signs and symptoms of DED when dosed QID for 2 weeks. KPI 121 appeared to be safe and well-tolerated and the incidence of IOP elevation, a known side effect with topical corticosteroids, was similar between the KPI-121 and vehicle arms in the completed trials.
- dexamethasone / Generic mfg., Decadron (dexamethasone) / Merck (MSD), loteprednol etabonate / Generic mfg.
[VIRTUAL] Randomized Controlled Trial Comparing Efficacy and Safety of Loteprednol Etabonate 0.5% and Dexamethasone 0.1% after Cataract Surgery (VM) - May 23, 2020 - Abstract #ASCRSASOA2020ASCRS-ASOA_2080;
Compliance and satisfaction with treatment was the same between groups (lowest p=0.27). Conclusion DEX and LE have similar outcomes with regards to control of inflammation, with no differences in adverse events, IOP elevation, visual acuity, CRT, or regimen compliance.
- | cyclosporine / Generic mfg.
Journal: Modulation of Inflammation-Related Genes in the Cornea of a Mouse Model of Dry Eye upon Treatment with Cyclosporine Eye Drops. (Pubmed Central) - May 17, 2020
This study indicates that the three CsA formulations effectively modulated TLR4, TGFβ1, IL1, and IL6 pathways to reduce corneal epithelium lesions in a mouse model of severe dry eye. The study also suggests that the different anti-inflammatory eye drops modulated inflammatory genes in a slightly different manner.
- || sofpironium bromide (BBI-4000) / Brickell, Kaken, loteprednol etabonate / Generic mfg.
Clinical, Journal: Development and clinical success of novel soft drugs (Pubmed Central) - Mar 8, 2020
Sofpironium bromide, a highly effective molecule but without the typical anticholinergic side effects, was first developed to treat hyperhidrosis, an unmet need...Orv Hetil. 2020; 161(10): 363-373.
- Eysuvis (loteprednol etabonate nano-suspension 0.25%) / Kala Pharma
Efficacy and Safety of KPI-121 0.25% for Short Term Relief in Dry Eye (STRIDE) (BCEC-Meeting Level 1,Room 152) - Mar 1, 2020 - Abstract #ASCRSASOA2020ASCRS-ASOA_1091;
P2, P3
Conclusion In the completed Phase II and STRIDE 1 trials KPI-121 0.25% improved both signs and symptoms of DED when dosed QID for 2 weeks. KPI 121 appeared to be safe and well-tolerated and the incidence of IOP elevation, a known side effect with topical corticosteroids, was similar between the KPI-121 and vehicle arms in the completed trials.
- | Decadron (dexamethasone) / Merck (MSD)
Retrospective data, Journal: Effect of Topical Periocular Steroid Use on Intraocular Pressure: A Retrospective Analysis. (Pubmed Central) - Jan 21, 2020
Periocular steroid treatment causes a statistically significant rise in IOP in eyes with higher baseline IOP measurements, the risk of which increases with follow up. While this change is not always correlated with a clinically significant rise in IOP, clinicians should monitor more closely patients at greatest risk of steroid response.
- | loteprednol etabonate / Generic mfg.
Journal: Salzmann's nodular degeneration of cornea associated with thyroid eye disease. (Pubmed Central) - Jan 19, 2020
The authors describe a patient with bilateral SND confirmed by anterior segment optical coherence tomography (OCT) imaging in the context of thyroid eye disease (TED) and history of LASIK. Treatment involved propylthiouracil (PTU), artificial tear use, loteprednol etabonate ophthalmic gel, eyelid taping and selenium supplementation and prospective superficial keratectomy with diamond burr polish.
- || Decadron (dexamethasone) / Merck (MSD), loteprednol etabonate / Generic mfg.
Clinical, Journal: Comparison of Efficacy and Safety of Loteprednol Etabonate 0.5% and Topical Dexamethasone 1% in Post-Vitrectomy Inflammation. (Pubmed Central) - Jan 9, 2020
Although DEX is more effective in the early postoperative days, LE appears to be as effective in controlling inflammatory response following PPV in the long-term. Topical LE is associated with less increase in the IOP and a lower need for anti-glaucoma medications.
- || cyclosporine / Generic mfg.
Clinical, Review, Journal: Efficacy, Safety and Steroid-sparing Effect of Topical Cyclosporine A 0.05% for Vernal Keratoconjunctivitis in Indian Children. (Pubmed Central) - Dec 26, 2019
No significant rise in IOP or any side effects were noted in either group. Topical Cs A 0.05% is effective and safe in patients with moderate to severe VKC with good steroid-sparing effect.
- || loteprednol etabonate / generics
Clinical, Journal: Efficacy and Safety of Loteprednol 0.5% and Fluorometholone 0.1% After Strabismus Surgery in Children. (Pubmed Central) - Nov 22, 2019
Loteprednol appeared to have more effect on IOP elevation than fluorometholone, especially in children ≤8 years of age. When treating young patients with loteprednol, clinicians should be aware of IOP elevation.
- | loteprednol etabonate / Generic mfg.
Trial completion: A Study to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5% (clinicaltrials.gov) - Nov 19, 2019
P4, N=140, Completed, Sponsor: Bausch & Lomb Incorporated
When treating young patients with loteprednol, clinicians should be aware of IOP elevation. Active, not recruiting --> Completed
- ||| loteprednol etabonate / Generic mfg.
Trial completion, Surgery: Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery (clinicaltrials.gov) - Nov 6, 2019
P1, N=381, Completed, Sponsor: Sandoz
Active, not recruiting --> Completed Active, not recruiting --> Completed
- | loteprednol etabonate / generics
Journal: Submicron loteprednol etabonate ophthalmic gel 0.38% for the treatment of inflammation and pain after cataract surgery. (Pubmed Central) - Nov 4, 2019
Active, not recruiting --> Completed In this study, submicron loteprednol etabonate gel 0.38% appeared safe and effective in the treatment of postoperative inflammation and pain whether instilled 2 times or 3 times a day.
- | dexamethasone / generics
Journal: Perioperative/Postoperative Anti-Inflammatory Therapy During/After Corneal Surgery/Transplantation (Pubmed Central) - Oct 24, 2019
The available glucocorticoids differ in their ability to penetrate into the eye (prednisolone best), their immunosuppressive activity (dexamethasone best) and their ability to induce a steroid response (loteprednol etabonate and fluorometholone least)...When allogeneic tissue is transplanted, long-term topical glucocorticoid use over 24 months or longer is necessary. After high-risk keratoplasty with allogeneic donor tissue, supplemental systemic immunosuppressive therapy with calcineurin inhibitors or mycophenolate mofetil over 6 to 12 months is recommended.
- loteprednol etabonate nano-suspension 0.25% (KPI-121 0.25%) / Kala Pharma
Safety and efficacy of KPI-121 0.25% for the treatment of signs and symptoms of dry eye disease in three multicentre randomised, double-masked, vehicle-controlled trials (Room: Poster Village: Pod 3) - Sep 16, 2019 - Abstract #ESCRS2019ESCRS_178;
P3
KPI 121 0.25% appeared to be safe and well-tolerated in all three trials. The incidence of IOP elevation, a known side effect associated with topical corticosteroids use, was similar between the KPI-121 and vehicle arms in all three trials.
- | loteprednol etabonate / Generic mfg.
Enrollment closed, Surgery: Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery (clinicaltrials.gov) - Sep 11, 2019
P1, N=350, Active, not recruiting, Sponsor: Sandoz
The incidence of IOP elevation, a known side effect associated with topical corticosteroids use, was similar between the KPI-121 and vehicle arms in all three trials. Recruiting --> Active, not recruiting
- | loteprednol etabonate / generics
Clinical, P3 data, Journal: Loteprednol etabonate (submicron) ophthalmic gel 0.38% dosed three times daily following cataract surgery: integrated analysis of two Phase III clinical studies. (Pubmed Central) - Aug 27, 2019
There were no reports of blurred vision with LE gel. The results of this integrated analysis indicate that LE (submicron) gel 0.38% administered TID is safe and effective for the treatment of ocular inflammation and pain following cataract surgery, with minimal risk of IOP elevation.
- | loteprednol etabonate / generics
Clinical, Journal, Real-World Evidence: Real world use of loteprednol etabonate ophthalmic gel 0.5% in cases representative of comorbid pathologies responding to minimally invasive glaucoma surgery. (Pubmed Central) - Aug 16, 2019
In two cases, patients with elevated IOP using either prednisolone or difluprednate postoperatively were switched to LE gel, with a subsequent reduction in IOP. This selection of cases involving patients undergoing MIGS suggests that LE gel may be an effective and safe option for treating postoperative inflammation and pain following such procedures with minimal to no effect on IOP or other negative sequalae.
- | loteprednol etabonate / Generic mfg.
Enrollment change, Surgery: Efficacy of Loteprednol Ointment Following Eyelid Surgery (clinicaltrials.gov) - Aug 1, 2019
P=N/A, N=0, Withdrawn, Sponsor: University of California, San Diego
This selection of cases involving patients undergoing MIGS suggests that LE gel may be an effective and safe option for treating postoperative inflammation and pain following such procedures with minimal to no effect on IOP or other negative sequalae. N=100 --> 0
- | Durezol (difluprednate ophthalmic emulsion) / Senju, Novartis
Journal: Ophthalmic medication price variation across the United States: Anti-inflammatory medications. (Pubmed Central) - Jul 31, 2019
Medication prices do not differ significantly between US cities. High variation of drug prices within the same city demonstrates how comparison shopping can provide cost savings for patients and may reduce cost-related nonadherence.
- | loteprednol etabonate / generics
Clinical, Journal: Reduced Efficacy of Low-dose Topical Steroids in Dry Eye Disease Associated with Graft-versus-host Disease. (Pubmed Central) - Jul 4, 2019
High variation of drug prices within the same city demonstrates how comparison shopping can provide cost savings for patients and may reduce cost-related nonadherence. DED patient with ocular GVHD have a less favorable response to a low-dose topical steroid regimen compared with those without ocular GVHD even with similar baseline disease severity.
- | loteprednol etabonate / Generic mfg.
Trial completion, Enrollment change, Surgery: Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children. (clinicaltrials.gov) - Jun 12, 2019
P3, N=107, Completed, Sponsor: Bausch & Lomb Incorporated
DED patient with ocular GVHD have a less favorable response to a low-dose topical steroid regimen compared with those without ocular GVHD even with similar baseline disease severity. Active, not recruiting --> Completed | N=170 --> 107
- | Lotemax (loteprednol etabonate) / Bausch Health, Acular (ketorolac ophthalmic) / Allergan, Grünenthal GmbH
Clinical, Journal: Safety & efficacy of single subconjunctival triamcinolone 5 mg depot vs topical loteprednol post cataract surgery: less drop cataract surgery. (Pubmed Central) - May 28, 2019
Active, not recruiting --> Completed | N=170 --> 107 SCTA appears to be an effective alternative to prolong postoperative topical steroid use.
- |||| Lotemax (loteprednol etabonate) / Bausch Health
Clinical: Does ur clinical analysis from #ARMOR & its microorganisms resistance monitoring refers to the ones found by th ones who r suppose 2 regulate ur #Bausch Tampa facility? Based on my knowledge u r not committed 2 the needs of #eyecare patients #Loteprednol #Lotemax #BHC #ARVO2019 (Twitter) - May 2, 2019
- | Lotemax (loteprednol etabonate) / Bausch Health
Preclinical, Journal: Development of simultaneous quantification method of loteprednol etabonate (LE) and its acidic metabolites, and analysis of LE metabolism in rat. (Pubmed Central) - Apr 26, 2019
The metabolism of LE proceeded via different pathways in human and rat plasma. LE was slowly hydrolyzed by paraoxonase in human plasma to 17α-monoester with a half-life of 12 hours, but by carboxylesterase in rat plasma to yield undetectable products, presumed to include the unstable 17β-monoester.
- || Lotemax (loteprednol etabonate) / Bausch Health
FDA event: Loteprednol etabonate ophthalmic suspension (generic version of @BauschLomb Lotemax SM) receives @US_FDA approval. #optometry (Twitter) - Apr 22, 2019
- | Lotemax (loteprednol etabonate) / Bausch Health
Preclinical, Journal: In vitro and ex vivo correlation of drug release from ophthalmic ointments. (Pubmed Central) - Apr 19, 2019
In addition, a plot of the in vitro release rate against the ex vivo release flux of the four ointment formulations, yielded a straight line (R > 0.98) for all three release methods. Accordingly, the rheological parameters may be useful in predicting in vitro as well as ex vivo release properties.
- || loteprednol etabonate / Generic mfg.
Trial completion date, Trial primary completion date, Surgery: Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery (clinicaltrials.gov) - Jan 17, 2019
P1, N=350, Recruiting, Sponsor: Sandoz
Accordingly, the rheological parameters may be useful in predicting in vitro as well as ex vivo release properties. Trial completion date: Feb 2019 --> Jun 2019 | Trial primary completion date: Jan 2019 --> May 2019
- | FML, FML Forte (fluorometholone ophthalmic suspension) / AbbVie
Trial completion: Loteprednol vs. Prednisolone and Fluorometholone (clinicaltrials.gov) - Oct 30, 2018
P4, N=214, Completed, Sponsor: University of Utah
Trial completion date: Feb 2019 --> Jun 2019 | Trial primary completion date: Jan 2019 --> May 2019 Active, not recruiting --> Completed
- ||| loteprednol etabonate / Generic mfg.
New P1 trial, Surgery: Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery (clinicaltrials.gov) - Jun 3, 2018
P1, N=350, Recruiting, Sponsor: Sandoz
- | loteprednol etabonate / Generic mfg.
Enrollment change, Trial completion date: The Utility of IVCM to Assess Cellular Response and Efficacy of Long-term Topical Steroid Treatment in Patients With DED (clinicaltrials.gov) - May 2, 2018
P4, N=41, Completed, Sponsor: Tufts Medical Center
Active, not recruiting --> Completed N=26 --> 41 | Trial completion date: Jun 2015 --> Jan 2018
- | FML, FML Forte (fluorometholone ophthalmic suspension) / AbbVie
Trial primary completion date: Loteprednol vs. Prednisolone and Fluorometholone (clinicaltrials.gov) - Nov 9, 2017
P4, N=214, Active, not recruiting, Sponsor: University of Utah
N=26 --> 41 | Trial completion date: Jun 2015 --> Jan 2018 Trial primary completion date: Sep 2017 --> Sep 2018
- ||||||| loteprednol etabonate / Generic mfg.
Trial completion, Surgery: LE Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery (clinicaltrials.gov) - Aug 30, 2017
P3, N=600, Completed, Sponsor: Valeant Pharmaceuticals International, Inc.
Trial primary completion date: Sep 2017 --> Sep 2018 Recruiting --> Completed
- | loteprednol etabonate / Generic mfg.
Trial completion: Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Installations (clinicaltrials.gov) - May 18, 2017
P1, N=15, Completed, Sponsor: Bausch & Lomb Incorporated
Recruiting --> Completed Recruiting --> Completed
- loteprednol etabonate / Generic mfg.
Enrollment open: Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Installations (clinicaltrials.gov) - May 2, 2017
P1, N=15, Recruiting, Sponsor: Bausch & Lomb Incorporated
Recruiting --> Completed Not yet recruiting --> Recruiting
- ||||| loteprednol etabonate / Generic mfg.
Enrollment closed, Trial primary completion date, Surgery: Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children. (clinicaltrials.gov) - Apr 26, 2017
P3, N=170, Active, not recruiting, Sponsor: Bausch & Lomb Incorporated
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2017 --> Jul 2017
- | FML, FML Forte (fluorometholone ophthalmic suspension) / AbbVie
New P4 trial: Loteprednol vs. Prednisolone and Fluorometholone (clinicaltrials.gov) - Apr 20, 2017
P4, N=214, Active, not recruiting, Sponsor: University of Utah
- | loteprednol etabonate / Generic mfg.
New P1 trial: Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Installations (clinicaltrials.gov) - Apr 4, 2017
P1, N=15, Not yet recruiting, Sponsor: Bausch & Lomb Incorporated
- | loteprednol etabonate / Generic mfg.
New P1 trial: Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability (clinicaltrials.gov) - Feb 24, 2017
P1, N=15, Completed, Sponsor: Valeant Pharmaceuticals International, Inc.
- |||| loteprednol etabonate / Generic mfg.
Trial primary completion date, Surgery: Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children. (clinicaltrials.gov) - Feb 11, 2017
P3, N=170, Recruiting, Sponsor: Bausch & Lomb Incorporated
Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2017 --> Jul 2017 Trial primary completion date: Apr 2016 --> Dec 2017
- ||| loteprednol etabonate / Generic mfg.
Enrollment change, Trial initiation date, Trial primary completion date: A Study to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5% (clinicaltrials.gov) - Feb 11, 2017
P4, N=140, Active, not recruiting, Sponsor: Bausch & Lomb Incorporated
Trial primary completion date: Apr 2016 --> Dec 2017 N=690 --> 140 | Initiation date: Feb 2011 --> Feb 2013 | Trial primary completion date: Oct 2013 --> Feb 2018
- |||||| loteprednol etabonate / Generic mfg.
Enrollment open, Surgery: LE Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery (clinicaltrials.gov) - Jan 26, 2017
P3, N=588, Recruiting, Sponsor: Valeant Pharmaceuticals International, Inc.
N=690 --> 140 | Initiation date: Feb 2011 --> Feb 2013 | Trial primary completion date: Oct 2013 --> Feb 2018 Not yet recruiting --> Recruiting
- | loteprednol etabonate / Generic mfg.
New P4 trial: Safety and Efficacy of Lotemax Versus FML in Subjects Undergoing PRK for the Correction of Mild to Moderate Myopia, 3- Month Follow-up Study (clinicaltrials.gov) - Nov 28, 2016
P4, N=200, Not yet recruiting, Sponsor: Dr Salouti Eye Research Center
- dexamethasone / Generic mfg., loteprednol etabonate / Generic mfg.
New trial, Surgery: Dexamethasone (Sterodex) Versus Loteprendol (Lotemax) Eye Drops Following Strabismus Surgery (clinicaltrials.gov) - Jul 7, 2016
P=N/A, N=100, Not yet recruiting, Sponsor: Tel-Aviv Sourasky Medical Center
- |||||||||| loteprednol etabonate / Generic mfg.
New P3 trial, Surgery: LE Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery (clinicaltrials.gov) - Jun 1, 2016
P3, N=588, Not yet recruiting, Sponsor: Valeant Pharmaceuticals International, Inc.
- | loteprednol etabonate / Generic mfg.
Trial completion, Enrollment change: The Utility of IVCM to Assess Cellular Response and Efficacy of Long-term Topical Steroid Treatment in Patients With DED (clinicaltrials.gov) - Oct 30, 2015
P4, N=26, Completed, Sponsor: Massachusetts Eye and Ear Infirmary
Not yet recruiting --> Recruiting Recruiting --> Completed | N=50 --> 26
- loteprednol etabonate / Generic mfg.
Trial completion, Enrollment change: Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty (clinicaltrials.gov) - May 2, 2015
P4, N=167, Completed, Sponsor: Cornea Research Foundation of America
Recruiting --> Completed | N=50 --> 26 Active, not recruiting --> Completed | N=220 --> 167
- |||| loteprednol etabonate / Generic mfg., cyclosporine ophthalmic emulsion / Generic mfg.
Trial completion, Trial primary completion date: Lotemax (clinicaltrials.gov) - Aug 22, 2014
P2, N=102, Completed, Sponsor: Bausch & Lomb Incorporated
Active, not recruiting --> Completed | N=220 --> 167 Active, not recruiting --> Completed | Trial primary completion date: Dec 2013 --> Mar 2014