David Wirta
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View article: Safety and Efficacy of a Preservative-Free Bimatoprost 0.01% Ophthalmic Gel: Results From a Phase III Controlled Trial
Safety and Efficacy of a Preservative-Free Bimatoprost 0.01% Ophthalmic Gel: Results From a Phase III Controlled Trial Open
Précis: Noninferiority on intraocular pressure (IOP)-lowering efficacy was demonstrated for a preservative-free (PF) bimatoprost 0.01% ophthalmic gel compared with a preserved formulation following a 3-month treatment in patients with open…
View article: Acoltremon Ophthalmic Solution 0.003% for Signs and Symptoms of Dry Eye Disease
Acoltremon Ophthalmic Solution 0.003% for Signs and Symptoms of Dry Eye Disease Open
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
View article: Sepetaprost 0.002% Noninferiority vs. Timolol 0.5% in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension
Sepetaprost 0.002% Noninferiority vs. Timolol 0.5% in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension Open
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
View article: Safety and Longevity of Intraocular Pressure Control After Bimatoprost Implant Administration: Interim Analysis of a Phase 3b Clinical Trial (TRITON)
Safety and Longevity of Intraocular Pressure Control After Bimatoprost Implant Administration: Interim Analysis of a Phase 3b Clinical Trial (TRITON) Open
View article: NivobotulinumtoxinA in the Treatment of Glabellar Lines With or Without Concurrent Treatment of Lateral Canthal Lines in Two Phase 3 Clinical Trials
NivobotulinumtoxinA in the Treatment of Glabellar Lines With or Without Concurrent Treatment of Lateral Canthal Lines in Two Phase 3 Clinical Trials Open
Background Botulinum neurotoxins in aesthetic medicine require reconstitution before administration, which may be inconvenient and present errors among injectors. Objectives The aim of this study was to evaluate the efficacy and safety of …
View article: Reversal of Pharmacologically Induced Mydriasis with Phentolamine Ophthalmic Solution
Reversal of Pharmacologically Induced Mydriasis with Phentolamine Ophthalmic Solution Open
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
View article: Recombinant human nerve growth factor (cenegermin) for moderate-to-severe dry eye: phase II, randomized, vehicle-controlled, dose-ranging trial
Recombinant human nerve growth factor (cenegermin) for moderate-to-severe dry eye: phase II, randomized, vehicle-controlled, dose-ranging trial Open
View article: Long-Term Safety and Efficacy of a Water-Free Cyclosporine 0.1% Ophthalmic Solution for Treatment of Dry Eye Disease: ESSENCE-2 OLE
Long-Term Safety and Efficacy of a Water-Free Cyclosporine 0.1% Ophthalmic Solution for Treatment of Dry Eye Disease: ESSENCE-2 OLE Open
Purpose: The ESSENCE-2 Open-Label Extension study aimed to demonstrate long-term safety, tolerability, and efficacy of a novel water-free, nonpreserved topical cyclosporine 0.1% ophthalmic solution (US brand name VEVYE) for patients with d…
View article: Omidenepag Isopropyl Versus Timolol in Patients With Glaucoma or Ocular Hypertension: Two Randomized Phase 3 Trials (SPECTRUM 4 and 3)
Omidenepag Isopropyl Versus Timolol in Patients With Glaucoma or Ocular Hypertension: Two Randomized Phase 3 Trials (SPECTRUM 4 and 3) Open
SPECTRUM 4 and 3 demonstrated consistent 3-month IOP-lowering efficacy and safety of OMDI vs timolol in patients with glaucoma or OHT. The 12-month data from SPECTRUM 3 suggest OMDI may have long-term benefits in patients with glaucoma or …
View article: Double-Masked, Vehicle-Controlled, Randomized, Phase II Study of the Ocular Hypotensive Activity and Safety of VVN539 Ophthalmic Solution
Double-Masked, Vehicle-Controlled, Randomized, Phase II Study of the Ocular Hypotensive Activity and Safety of VVN539 Ophthalmic Solution Open
To assess safety and ocular hypotensive efficacy of VVN539 ophthalmic solution in a first-in-human study. Multicenter, double-masked, randomized, vehicle-controlled, dose-response, parallel-comparison study. Sixty-eight subjects with ocula…
View article: Single Administration of Bimatoprost Implant
Single Administration of Bimatoprost Implant Open
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
View article: Two Randomized, Double-masked, Placebo-controlled Studies of the Local Anesthetic Effect of Articaine Ophthalmic Solution
Two Randomized, Double-masked, Placebo-controlled Studies of the Local Anesthetic Effect of Articaine Ophthalmic Solution Open
AG-920 was found to be have a rapid onset and useful duration of local anesthesia with no major safety issues, and may be useful for the eye-care professional. Registered with clinicaltrials.gov as NCT04513652 and NCT04829344.
View article: Efficacy and Safety of a Water-Free Topical Cyclosporine, 0.1%, Solution for the Treatment of Moderate to Severe Dry Eye Disease
Efficacy and Safety of a Water-Free Topical Cyclosporine, 0.1%, Solution for the Treatment of Moderate to Severe Dry Eye Disease Open
Importance Dry eye disease (DED) is a common public health problem with significant impact on vision-related quality of life and well-being of patients. Medications with rapid onset of action and a good tolerability profile remain an unmet…
View article: Safety and Target Engagement of Complement C1q Inhibitor ANX007 in Neurodegenerative Eye Disease
Safety and Target Engagement of Complement C1q Inhibitor ANX007 in Neurodegenerative Eye Disease Open
View article: A randomized, vehicle-controlled, Phase 2b study of two concentrations of the TRPM8 receptor agonist AR-15512 in the treatment of dry eye disease (COMET-1)
A randomized, vehicle-controlled, Phase 2b study of two concentrations of the TRPM8 receptor agonist AR-15512 in the treatment of dry eye disease (COMET-1) Open
Although predefined co-primary study endpoints were not met, AR-15512 demonstrated statistically significant improvements in DED signs, symptoms, and disease-related QoL.
View article: Lotilaner Ophthalmic Solution, 0.25%, for the Treatment of Demodex Blepharitis: Results of a Prospective, Randomized, Vehicle-Controlled, Double-Masked, Pivotal Trial (Saturn-1)
Lotilaner Ophthalmic Solution, 0.25%, for the Treatment of Demodex Blepharitis: Results of a Prospective, Randomized, Vehicle-Controlled, Double-Masked, Pivotal Trial (Saturn-1) Open
Purpose: The purpose of this study was to evaluate the safety and efficacy of lotilaner ophthalmic solution, 0.25%, compared with vehicle for the treatment of Demodex blepharitis. Methods: In this prospective, randomized, controlled, doubl…
View article: A Comparison of TearCare and Lipiflow Systems in Reducing Dry Eye Disease Symptoms Associated with Meibomian Gland Disease
A Comparison of TearCare and Lipiflow Systems in Reducing Dry Eye Disease Symptoms Associated with Meibomian Gland Disease Open
NCT03857919.
View article: Safety and Efficacy of AGN-190584 in Individuals With Presbyopia
Safety and Efficacy of AGN-190584 in Individuals With Presbyopia Open
ClinicalTrials.gov Identifier: NCT03804268.
View article: Phase 2b, Randomized, 3-Month, Dose-Finding Study of Sepetaprost in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: The ANGEL Study
Phase 2b, Randomized, 3-Month, Dose-Finding Study of Sepetaprost in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: The ANGEL Study Open
Purpose: This phase 2b, randomized, observer-masked, placebo- and active-controlled, parallel-group, multinational (USA and Japan), multicenter study (NCT03216902) assessed the optimal dose of sepetaprost ophthalmic solution …
View article: ONSET-1 Phase 2b Randomized Trial to Evaluate the Safety and Efficacy of OC-01 (Varenicline Solution) Nasal Spray on Signs and Symptoms of Dry Eye Disease
ONSET-1 Phase 2b Randomized Trial to Evaluate the Safety and Efficacy of OC-01 (Varenicline Solution) Nasal Spray on Signs and Symptoms of Dry Eye Disease Open
Purpose: The purpose of this trial was to evaluate the safety and efficacy of OC-01 (varenicline solution), a nicotinic acetylcholine receptor agonist nasal spray, on signs and symptoms of dry eye disease. Methods: A phase 2b, multicenter,…
View article: Efficacy and Safety of OC-01 (Varenicline Solution) Nasal Spray on Signs and Symptoms of Dry Eye Disease
Efficacy and Safety of OC-01 (Varenicline Solution) Nasal Spray on Signs and Symptoms of Dry Eye Disease Open
OC-01 nasal spray was well tolerated and showed a clinically meaningful effect on signs and symptoms of dry eye disease.
View article: Phase 3, Randomized, 20-Month Study of the Efficacy and Safety of Bimatoprost Implant in Patients with Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 2)
Phase 3, Randomized, 20-Month Study of the Efficacy and Safety of Bimatoprost Implant in Patients with Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 2) Open
View article: Repository Corticotropin Injection (Acthar® Gel) for Refractory Severe Noninfectious Keratitis: Efficacy and Safety from a Phase 4, Multicenter, Open-Label Study
Repository Corticotropin Injection (Acthar® Gel) for Refractory Severe Noninfectious Keratitis: Efficacy and Safety from a Phase 4, Multicenter, Open-Label Study Open
ClinicalTrials.gov NCT04169061.
View article: Combinations of Pilocarpine and Oxymetazoline for the Pharmacological Treatment of Presbyopia
Combinations of Pilocarpine and Oxymetazoline for the Pharmacological Treatment of Presbyopia Open
View article: Safety of Once-Daily Oxymetazoline HCl Ophthalmic Solution, 0.1% in Patients with Acquired Blepharoptosis: Results from Four Randomized, Double-Masked Clinical Trials
Safety of Once-Daily Oxymetazoline HCl Ophthalmic Solution, 0.1% in Patients with Acquired Blepharoptosis: Results from Four Randomized, Double-Masked Clinical Trials Open
Once-daily oxymetazoline 0.1% was safe and well tolerated in participants with acquired blepharoptosis when used for 14-84 days. Safety did not appear to differ based on age, race, or ethnicity.
View article: Assessing Presbyopia Impacts and Coping Behaviors with a de Novo PRO Instrument in a Phase 3 Study of AGN-190584 (Pilocarpine 1.25%)
Assessing Presbyopia Impacts and Coping Behaviors with a de Novo PRO Instrument in a Phase 3 Study of AGN-190584 (Pilocarpine 1.25%) Open
View article: Corneal endothelial cell loss associated with selective laser trabeculoplasty
Corneal endothelial cell loss associated with selective laser trabeculoplasty Open
View article: Rapid and Sustained Eyelid Elevation in Acquired Blepharoptosis with Oxymetazoline 0.1%: Randomized Phase 3 Trial Results
Rapid and Sustained Eyelid Elevation in Acquired Blepharoptosis with Oxymetazoline 0.1%: Randomized Phase 3 Trial Results Open
Oxymetazoline 0.1% provided rapid and sustained upper eyelid elevation. Together with data demonstrating superior visual field improvement and a favorable safety profile, this analysis supports oxymetazoline 0.1% as an effective non-surgic…
View article: Mydriasis With Micro-Array Print Touch-Free Tropicamide-Phenylephrine Fixed Combination MIST: Pooled Randomized Phase III Trials
Mydriasis With Micro-Array Print Touch-Free Tropicamide-Phenylephrine Fixed Combination MIST: Pooled Randomized Phase III Trials Open
Design: Prospective, double-masked, controlled, cross-over superiority studies. Materials & methods: Eligible volunteers in two pooled Phase III trials received microdosed mydriatics. MIST-1 study subjects received fixed-comb…
View article: A Water-free 0.1% Cyclosporine A Solution for Treatment of Dry Eye Disease: Results of the Randomized Phase 2B/3 ESSENCE Study
A Water-free 0.1% Cyclosporine A Solution for Treatment of Dry Eye Disease: Results of the Randomized Phase 2B/3 ESSENCE Study Open
Purpose: To assess the efficacy, safety, and tolerability of a topical water-free cyclosporine A formulation (CyclASol 0.1% ophthalmic solution) in comparison with vehicle for the treatment of dry eye disease (DED). Methods: Three hundred …