Frequently Asked Questions

Dale W. Usner, PhD

Years: 20+ years in Clinical Trials and Healthcare

Positions: 

• VP of Biostatistics, Data Management, and Programming: Glaukos Corporation
• CSO and President: Statistics & Data Corporation, CRO focused on Statistics, Data Management, and Programming
• Global VP of Biostatistics, Data Management, and Programming: Bausch & Lomb

Indication Expertise: 

• Glaucoma/Ocular Hypertension
• Dry Eye
• nAMD, DME, RVO
• Dry AMD / GA, 
• Keratoconus 
• Ocular Allergy, Bacterial Conjunctivitis 
• Post-Op Inflammation & Pain, Anterior and Posterior Uveitis 
• Blepharitis, Demodex Blepharitis
• Presbyopia, Myopia
• Persistent Corneal Epithelial Defect
• 
  

Regulatory Interactions

• 100+ interactions, including briefing document input, dialogue with the FDA around statistical components of strategy in meetings (face to face and online), written responses to comments.
• Responding statistician in two advisory committee meetings.  
• Statistician or Reviewing Statistician on 12+  approvals across CDER and CDRH

I provide statistical consulting services within the pharmaceutical, biotech, and device industry including the following, with focus on clinical trials:

     1. FDA meeting preparation and attendance (CDER and CDRH)

     2. Program strategy, accounting for safety and efficacy requirements

     3. Protocol Study Design Strategy Development:

            a) Endpoint Determination

            b) Sample Size and Power

            c) Multiple Endpoints 

            d) Adaptive Designs

            e) Interim Analyses

     4. Documentation Review: Protocol; Statistical Analysis Plan; Table, Listing, and Figure (TLF)  

                shells, Randomization plans, Case Report Forms.

     5. Data Monitoring Committee Board Member, Documentation Development/Review

     6. Outcome (TLFs) and Clinical Study Report Review and Input

     7. Adhoc and Posthoc analyses

     8. Integrated Summaries of Safety (ISS) and Efficacy (ISE) Strategy

     9. Formal TLF development through recommended CROs.

   10. Data Package (SDTM/ADaM Versions and IG) Review and Development through Consultants

John P. Berdahl; Steven R. Sarkisian, Jr; Robert E. Ang; Long V. Doan; Angela C. Kothe; Dale W. Usner; L. Jay Katz; Tomas Navratil; Robert E. T. Ang; Jason Bacharach et al.  Efficacy and Safety of the Travoprost Intraocular Implant in Reducing Topical IOP-Lowering Medication Burden in Patients with Open-Angle Glaucoma or Ocular Hypertension.  Drugs. 84: 83-97, 2024.

Iqbal Ike K. Ahmed; Arsham Sheybani; Ticiana De Francesco; Jonathan H. Lass; Beth Ann Benetz; Thomas W. Samuelson; Dale Usner; L. Jay Katz.   Long-Term Endothelial Safety Profile with iStent Inject in Patients with Open-Angle Glaucoma.  American Journal of Ophthalmology. 252: 17-25, 2023.

Walters, T.R.; Kothe, A.C.; Boyer, J.L.; Usner, D.W.; Lopez, K.; Duquesroix, B.; Fechtner, R.D.; Navratil, T.   A Randomized, Controlled Comparison of NCX 470 (0.021%, 0.042%, and 0.065%) and Latanoprost 0.005% in Patients with Open-angle Glaucoma or Ocular Hypertension: The Dolomites Study. Journal of Glaucoma. 31(6): 382-391, 2022. 

Korenfeld, M.; Gira, J.; Jong, K.; Martel, J.; Vold, S.; Walters, T.; Usner, D.; Donnenfeld, E.  OCS-01 (Novel Topical Dexamethasone Formulation) in Inflammation and Pain Post Cataract Surgery: A randomized, Double Masked, Vehicle-Controlled Study. Clinical Therapeutics. 44(12): 1577-1587, 2022

Sheppard, J.D.; Wirta, D.L.; McLaurin, E.; Boehmer, B.E.; Ciolino, J.B.; Meides, A.S.; Schlüter, T.; Ousler, G.W.; Usner, D.; Krösser, S.  A Water-free 0.1% Cyclosporine A Solution for Treatment of Dry Eye Disease: Results of the Randomized Phase 2B/3 ESSENCE Study. Cornea.  40(10): 1290-1297, 2021. 

Singh I, Fechtner R, Myers J, Kim T, Usner D, McKee H, Sheng H, Lewis R, Heah T, Kopczynski C. Pooled Efficacy and Safety Profile of Netarsudil Ophthalmic Solution 0.02% in Patients with Open-angle Glaucoma or Ocular Hypertension. Journal of Glaucoma. 2020. 

Brubaker J, Teymoorian S, Lewis R, Usner D, McKee H, Ramirez N, Kopczynski Casey, Heah T. One Year of Netarsudil and Latanoprost Fixed-Dose Combination for Elevated Intraocular Pressure: Phase 3, Randomized MERCURY-1 Study. Ophthalmology Glaucoma. 2020. 

Walters T, Ahmed I, Lewis R, Usner D, Lopez J, Kopczynski C, Heah T. Once-Daily Netarsudil/Latanoprost Fixed-Dose Combination for Elevated Intraocular Pressure in the Randomized Phase 3 MERCURY-2 Study. Ophthalmology Glaucoma. 2(5): 280-289, 2019. 

Asrani S, Robin A, Serle J, Lewis RA, Usner D, Kopczynski C, Heah T. Netarsudil/Latanoprost Fixed-Dose Combination for Elevated Intraocular Pressure: 3-Month Data from a Randomized Phase 3 Trial. American Journal of Ophthalmology. 207:248-257, 2019. 

Khouri AS, Serle JB, Bacharach J, Usner DW, Lewis RA, Braswell P, Kopczynski CC, Heah T, Rocket-4 Study Group. Once-Daily Netarsudil Versus Twice-Daily Timolol in Patients with Elevated Intraocular Pressure: The Randomized Phase 3 ROCKET-4 Study. American Journal of Ophthalmology. 204:97-104, 2019.  

Kahook MY, Serle JB, Mah FS, Kim T, Raizman MB, Heah T, Ramirez-Davis N, Kopczynski CC, Usner DW, Novack GD, ROCKET-2 Study Group. Long-term Safety and Ocular Hypotensive Efficacy Evaluation of Netarsudil Ophthalmic Solution: Rho Kinase Elevated IOP Treatment Trial (ROCKET-2). American Journal of Ophthalmology. 200:130-137, 2019. 

Serle JB, Katz LJ, McLaurin E, Heah T, Ramirez-Davis N, Usner DW, Novack GD, Kopczynski  CC, ROCKET-1 and ROCKET-2 Study Groups. Two phase 3 clinical trials comparing the  safetyand efficacy of netarsudil to timolol in patients with elevated intraocular pressure: Rho Kinase Elevated IOP Treatment Trial 1 and 2 (ROCKET-1 and ROCKET-2). American Journal of Ophthalmology. 186:116-27, 2018. 

Lewis RA, Levy B, Ramirez N, Kopczynski CC, Usner DW, Novack GD; PG324-CS201 Study Group. Fixed-dose combination of AR-13324 and latanoprost: a double-masked, 28-day, randomised, controlled study in patients with open-angle glaucoma or ocular hypertension. British Journal of Ophthalmology. 100(3):339-44, 2016. 

Ramos EL, Mitcham JL, Koller TD, Bonavia A, Usner DW, Balaratnam G, Fredlund P,  SwiderekKM. Efficacy and safety of treatment with an anti-M2e monoclonal antibody in experimental human influenza. Journal of Infectious Disease. 211(7):1038-44, 2015. 

Shapiro A, Usner D. The clinical data management process. Retina Today. Nov/Dec 2014. 

Shapiro A, Usner D. Clinical Trials from the Statistician’s Side: Reducing Variability. Retina Today. Jul/Aug 2012. 

Sheppard Jr JD, Nguyen QD, Usner DW, Comstock TL, Fluocinolone Acetonide Uveitis Study Group. Post-cataract outcomes in patients with noninfectious posterior uveitis treated with the fluocinolone acetonide intravitreal implant. Clinical Ophthalmology. 6:79-85, 2012. 

Haas W, Gearinger LS, Usner DW, DeCory HH, Morris TW. Integrated analysis of three bacterial conjunctivitis trials of besifloxacin ophthalmic suspension, 0.6%: etiology of bacterial conjunctivitis and antibacterial susceptibility profile. Clinical Ophthalmology. 5:1369-79, 2011. 

Morris TW, Gearinger LS, Usner DW, Paterno MR, DeCory HH, Comstock TL, Haas W. Integrated analysis of three bacterial conjunctivitis trials of besifloxacin ophthalmic suspension, 0.6%: microbiological eradication outcomes. Clinical Ophthalmology. 5:1359-67, 2011. 

Comstock TL, Paterno MR, Decory HH, Usner DW. Safety and tolerability of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis: data from six clinical and phase I safety studies. Clinical Drug Investigation. 30(10):675-85, 2010. 

Comstock TL, Paterno MR, Usner DW, Pichichero ME. Efficacy and safety of besifloxacin ophthalmic suspension 0.6% in children and adolescents with bacterial conjunctivitis: a post hoc, subgroup analysis of three randomized, double-masked, parallel-group, multicenter clinical trials. Paediatric Drugs. 12(2):105-12, 2010 Apr 1. 

Pavesio C, Zierhut M, Bairi K, Comstock TL, Usner DW. Fluocinolone Acetonide Study Group. Evaluation of an intravitreal fluocinolone acetonide implant versus standard systemic therapy in noninfectious posterior uveitis. Ophthalmology. 117(3):567-75, 575.e1, 2010 Mar.

McDonald MB, Protzko EE, Brunner LS, Morris TW, Haas W, Paterno MR, Comstock TL, Usner DW. Efficacy and safety of besifloxacin ophthalmic suspension 0.6% compared with moxifloxacin ophthalmic solution 0.5% for treating bacterial conjunctivitis. Ophthalmology.  116(9):1615-1623.e1, 2009 Sep. 

Tepedino ME, Heller WH, Usner DW, Brunner LS, Morris TW, Haas W, Paterno MR, Comstock TL. Phase III efficacy and safety study of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis. Current Medical Research & Opinion. 25(5):1159- 69, 2009 May. 

Karpecki P, Depaolis M, Hunter JA, White EM, Rigel L, Brunner LS, Usner DW, Paterno MR, Comstock TL, Besifloxacin ophthalmic suspension 0.6% in patients with bacterial conjunctivitis: A multicenter, prospective, randomized, double-masked, vehicle-controlled, 5-day efficacy and safety study. Clinical Therapeutics. 31(3):514-26, 2009 Mar. 

Bartlett JD, Holland EJ, Usner DW, Paterno MR, Comstock TL, Tolerability of loteprednol/tobramycin versus dexamethasone/tobramycin in healthy volunteers: results of a 4-week, randomized, double-masked, parallel-group study. Current Medical Research & Opinion.  24(8):2219-27, 2008 Aug. 

Holland EJ, Bartlett JD, Paterno MR, Usner DW, Comstock TL. Effects of loteprednol/tobramycin versus dexamethasone/tobramycin on intraocular pressure in healthy volunteers. Cornea. 27(1):50-5, 2008 Jan. [Erratum appears in Cornea. 2008 Apr;27(3):389] 

Goldstein DA, Godfrey DG, Hall A, Callanan DG, Jaffe GJ, Pearson PA, Usner DW, Comstock TL. Intraocular pressure in patients with uveitis treated with fluocinolone acetonide implants. Archives of Ophthalmology. 125(11):1478-85, 2007 Nov.