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Original Research

A Phase II/III, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of OTX-101 in the treatment of dry eye disease

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Pages 1921-1929 | Published online: 02 Oct 2018

Keep up to date with the latest research on this topic with citation updates for this article.

Read on this site (11)

Melissa Toyos, Preeya K. Gupta, Brittany Mitchell & Paul Karpecki. (2022) The Effect of OTX-101 on Tear Production in Patients with Severe Tear-deficient Dry Eye Disease: A Pooled Analysis of Phase 2b/3 and Phase 3 Studies. Current Eye Research 47:2, pages 220-224.
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Cynthia Matossian, William Trattler & Jennifer Loh. (2021) Dry Eye Treatment with Topical Cyclosporine 0.1% in Chondroitin Sulfate Ophthalmic Emulsion. Clinical Ophthalmology 15, pages 1979-1984.
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John Sheppard, Mark Bergmann, Barry A Schechter, Jodi Luchs, Abayomi Ogundele & Paul Karpecki. (2021) Phase 3 Efficacy (Worse-Eye Analysis) and Long-Term Safety Evaluation of OTX-101 in Patients with Keratoconjunctivitis Sicca. Clinical Ophthalmology 15, pages 129-140.
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Michele Figus, Luca Agnifili, Manuela Lanzini, Lorenza Brescia, Francesco Sartini, Leonardo Mastropasqua & Chiara Posarelli. (2021) Topical preservative-free ophthalmic treatments: an unmet clinical need. Expert Opinion on Drug Delivery 18:6, pages 655-672.
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Kelly K. Nichols, David G. Evans & Paul M. Karpecki. (2021) A Comprehensive Review of the Clinical Trials Conducted for Dry Eye Disease and the Impact of the Vehicle Comparators in These Trials. Current Eye Research 46:5, pages 609-614.
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Laura M Periman, Francis S Mah & Paul M Karpecki. (2020) A Review of the Mechanism of Action of Cyclosporine A: The Role of Cyclosporine A in Dry Eye Disease and Recent Formulation Developments. Clinical Ophthalmology 14, pages 4187-4200.
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Bridgitte Shen Lee, Alan G Kabat, Jason Bacharach, Paul Karpecki & Jodi Luchs. (2020) Managing Dry Eye Disease and Facilitating Realistic Patient Expectations: A Review and Appraisal of Current Therapies. Clinical Ophthalmology 14, pages 119-126.
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Gary W Jerkins, Guruprasad R Pattar & Shane R Kannarr. (2020) A Review of Topical Cyclosporine A Formulations—A Disease-Modifying Agent for Keratoconjunctivitis Sicca. Clinical Ophthalmology 14, pages 481-489.
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Rodrigo Carlos de Oliveira & Steven E Wilson. (2019) Practical guidance for the use of cyclosporine ophthalmic solutions in the management of dry eye disease. Clinical Ophthalmology 13, pages 1115-1122.
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Maria Aurora Grimaudo, Silvia Pescina, Cristina Padula, Patrizia Santi, Angel Concheiro, Carmen Alvarez-Lorenzo & Sara Nicoli. (2019) Topical application of polymeric nanomicelles in ophthalmology: a review on research efforts for the noninvasive delivery of ocular therapeutics. Expert Opinion on Drug Delivery 16:4, pages 397-413.
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Articles from other publishers (25)

Kevin Y. Wu, Said Ashkar, Shrieda Jain, Michael Marchand & Simon D. Tran. (2023) Breaking Barriers in Eye Treatment: Polymeric Nano-Based Drug-Delivery System for Anterior Segment Diseases and Glaucoma. Polymers 15:6, pages 1373.
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Victor L. PerezFrancis S. MahMark WillcoxStephen Pflugfelder. (2023) Anti-Inflammatories in the Treatment of Dry Eye Disease: A Review. Journal of Ocular Pharmacology and Therapeutics 39:2, pages 89-101.
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John D. Sheppard, Leslie E. O'Dell, Paul M. Karpecki, Michael B. Raizman, Walter O. Whitley, Gretchen Blemker, Mandy Hemphill, Laura H. Hendrix, Andrea Gibson & Marian Macsai. (2023) Does Dry Eye Disease Severity Impact Efficacy of Varenicline Solution Nasal Spray on Sign and Symptom Treatment Outcomes?. Optometry and Vision Science 100:2, pages 164-169.
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Jennifer B. Nadelmann, Vatinee Y. Bunya, Ilaria Macchi & Mina Massaro-Giordano. 2023. Dry Eye Disease. Dry Eye Disease 153 179 .
Barry A Schechter, Maitee Urbieta, Jason Bacharach, Melissa Toyos, Robert Smyth-Medina, Brittany Mitchell & Jodi I Luchs. (2022) Effect of OTX-101 in Patients with Dry Eye Disease at Day 14 of Treatment: Ocular Surface Endpoint Results from the Phase 2b/3 Clinical Trial. Clinical Ophthalmology Volume 16, pages 4145-4151.
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Dongyang Gao, Zhuoli Da, Kan Yang & Yuanyuan Shi. (2022) Comparison of seven cyclosporine A formulations for dry eye disease: A systematic review and network meta-analysis. Frontiers in Pharmacology 13.
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Jennifer B. Nadelmann, Angela Gupta, Caroline W. Chung & Stephen E. Orlin. (2022) Stepwise Approach to the Diagnosis and Management of Dry Eye and Ocular Surface Disease. Advances in Ophthalmology and Optometry 7:1, pages 325-344.
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Hebatallah B. Mohamed, Basma N. Abd El-Hamid, Dina Fathalla & Ehab A Fouad. (2022) Current trends in pharmaceutical treatment of dry eye disease: A review. European Journal of Pharmaceutical Sciences 175, pages 106206.
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Bridgitte Shen Lee, Melissa Toyos, Paul Karpecki, Jessica Schiffbauer & John Sheppard. (2022) Selective Pharmacologic Therapies for Dry Eye Disease Treatment: Efficacy, Tolerability, and Safety Data Review from Preclinical Studies and Pivotal Trials. Ophthalmology and Therapy 11:4, pages 1333-1369.
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Melissa Toyos, Rolando Toyos, Barbara Jodoin & Ryan Bunch. (2022) Results from a Prospective, Open-Label, Phase 4 Pilot Study of Repository Corticotropin Injection for Moderate and Severe Dry Eye Disease. Ophthalmology and Therapy 11:3, pages 1231-1240.
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Hugo Quiroz-Mercado, Everardo Hernandez-Quintela, Kuei Hsun Chiu, Eugenia Henry & Jeffrey A. Nau. (2022) A phase II randomized trial to evaluate the long-term (12-week) efficacy and safety of OC-01 (varenicline solution) nasal spray for dry eye disease: The MYSTIC study. The Ocular Surface 24, pages 15-21.
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Hideki Miyake, Philippe Daull & Mourad Amrane. 2022. Handbook of Basic and Clinical Ocular Pharmacology and Therapeutics. Handbook of Basic and Clinical Ocular Pharmacology and Therapeutics 423 445 .
Amandine Gendron, Natalie Lan Linh Tran, Julie Laloy, Romain Brusini, Aurélie Rachet, Frédéric Gobeaux, Valérie Nicolas, Pierre Chaminade, Sonia Abreu, Didier Desmaële & Mariana Varna. (2021) New Nanoparticle Formulation for Cyclosporin A: In Vitro Assessment. Pharmaceutics 13:1, pages 91.
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Nai-Wen Fan, Thomas H. Dohlman, William Foulsham, Matthew McSoley, Rohan Bir Singh, Yihe Chen & Reza Dana. (2021) The role of Th17 immunity in chronic ocular surface disorders. The Ocular Surface 19, pages 157-168.
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Subramanian Natesan, Sai H.S. Boddu, Venkateshwaran Krishnaswami & Moyad Shahwan. (2020) The Role of Nano-ophthalmology in Treating Dry Eye Disease. Pharmaceutical Nanotechnology 8:4, pages 258-289.
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Preeya K. Gupta, Penny Asbell & John Sheppard. (2020) Current and Future Pharmacological Therapies for the Management of Dry Eye. Eye & Contact Lens: Science & Clinical Practice 46:2, pages S64-S69.
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John Sheppard, Shane Kannarr, Jodi Luchs, Ranjan Malhotra, Angela Justice, Abayomi Ogundele, Charles Darby & Jason Bacharach. (2020) Efficacy and Safety of OTX-101, a Novel Nanomicellar Formulation of Cyclosporine A, for the Treatment of Keratoconjunctivitis Sicca: Pooled Analysis of a Phase 2b/3 and Phase 3 Study. Eye & Contact Lens: Science & Clinical Practice 46:1, pages S14-S19.
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Inna A. Riks. (2019) Cyclosporine use in “dry eye” syndrome. Ophthalmology Reports 12:3, pages 75-82.
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Ranjan Malhotra, Douglas K. Devries, Jodi Luchs, Alan Kabat, Barry A. Schechter, Bridgitte Shen Lee, Lee Shettle, Robert Smyth-Medina, Abayomi Ogundele, Charles Darby, Jason Bacharach & Paul Karpecki. (2019) Effect of OTX-101, a Novel Nanomicellar Formulation of Cyclosporine A, on Corneal Staining in Patients With Keratoconjunctivitis Sicca: A Pooled Analysis of Phase 2b/3 and Phase 3 Studies. Cornea 38:10, pages 1259-1265.
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Robert Smyth-MedinaJosh JohnstonDouglas K. DevriesApril JasperShane R. KannarrBarry A. SchechterBridgitte Shen LeeGeorge VargheseAbayomi OgundeleCharles H. DarbyPaul KarpeckiJodi Luchs. (2019) Effect of OTX-101, a Novel Nanomicellar Formulation of Cyclosporine A, on Conjunctival Staining in Patients with Keratoconjunctivitis Sicca: A Pooled Analysis of Phase 2b/3 and 3 Clinical Trials. Journal of Ocular Pharmacology and Therapeutics 35:7, pages 388-394.
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Sidney L. WeissWilliam G. Kramer. (2019) Ocular Distribution of Cyclosporine Following Topical Administration of OTX-101 in New Zealand White Rabbits. Journal of Ocular Pharmacology and Therapeutics 35:7, pages 395-402.
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Damien F. Goldberg, Ranjan P. Malhotra, Barry A. Schechter, Angela Justice, Sidney L. Weiss & John D. Sheppard. (2019) A Phase 3, Randomized, Double-Masked Study of OTX-101 Ophthalmic Solution 0.09% in the Treatment of Dry Eye Disease. Ophthalmology 126:9, pages 1230-1237.
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Tuo Meng, Vineet Kulkarni, Russell Simmers, Vikram Brar & Qingguo Xu. (2019) Therapeutic implications of nanomedicine for ocular drug delivery. Drug Discovery Today 24:8, pages 1524-1538.
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Erin C. O’Neil, Matthew Henderson, Mina Massaro-Giordano & Vatinee Y. Bunya. (2019) Advances in dry eye disease treatment. Current Opinion in Ophthalmology 30:3, pages 166-178.
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Abhirup Mandal, Vrinda Gote, Dhananjay Pal, Abayomi Ogundele & Ashim K. Mitra. (2019) Ocular Pharmacokinetics of a Topical Ophthalmic Nanomicellar Solution of Cyclosporine (Cequa®) for Dry Eye Disease. Pharmaceutical Research 36:2.
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