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OCS-01 (Novel Topical Dexamethasone Formulation) in Inflammation and Pain Post Cataract Surgery: A Randomized, Double-Masked, Vehicle-Controlled Study

      ABSTRACT

      Purpose

      The goal of this study was to compare topical dexamethasone 1.5% in a novel formulation (OCS-01) once daily and BID versus vehicle for the treatment of inflammation and pain after cataract surgery.

      Methods

      This was a Phase II, double-masked, vehicle-controlled, randomized multicenter study. Adult patients with planned unilateral uncomplicated cataract surgery were randomized to receive OCS-01 once daily (n = 51), OCS-01 BID (n = 51), or matching vehicle (n = 51) for 15 days postsurgery. Primary end points were absence of anterior chamber cells (ACC; cells = 0) at Day 15 and absence of pain (score of “0”) at postoperative Day 4. The Pearson χ2 test with a two-sided alpha = 0.1 was used to compare treatments. Safety was assessed in terms of adverse events and changes in intraocular pressure.

      Findings

      Treatment arms were generally similar in their baseline characteristics, with mean age ranging from 66 to 68 years, the proportion of male patients ranging from 29% to 37%, and 82% to 92% of each arm being White. On Day 15, a greater reduction in the percentage of eyes with ACC grade 0 was observed in the OCS-01 once daily (51%) and BID (66.7%) arms than in the vehicle arm (19.6%) (P = 0.0009 and P < 0.0001, respectively, using a Pearson χ2 test). On Day 4, the percentage of eyes with no pain was 72.5% (OCS-01 once daily), 62.7% (OCS-01 BID), and 45.1% (vehicle); statistical significance was reached for OCS-01 once daily (P = 0.005) and OCS-01 BID (P = 0.074) compared with vehicle. OCS-01 was well tolerated. A higher proportion of treatment-emergent adverse events, including ocular adverse events, were reported for the placebo group than for either OCS-01 group.

      Implications

      OCS-01 once daily and BID were more effective than vehicle and well tolerated in the treatment of inflammation and pain after cataract surgery. ClinicalTrials.gov identifier: NCT04130802.

      Key words

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      References

        • Hatch WV
        • Campbell Ede L
        • Bell CM
        • El-Defrawy SR
        • Campbell RJ.
        Projecting the growth of cataract surgery during the next 25 years.
        Arch Ophthalmol. 2012; 130: 1479-1481
        • Gira JP
        • Sampson R
        • Silverstein SM
        • Walters TR
        • Metzinger JL
        • Talamo JH.
        Evaluating the patient experience after implantation of a 0.4 mg sustained release dexamethasone intracanalicular insert (Dextenza): results of a qualitative survey.
        Patient Prefer Adherence. 2017; 11: 487-494
        • Mohammadpour M
        • Jafarinasab MR
        • Javadi MA.
        Outcomes of acute postoperative inflammation after cataract surgery.
        Eur J Ophthalmol. 2007; 17: 20-28
        • Sherif Z
        • Pleyer U.
        Corticosteroids in ophthalmology: past-present-future.
        Ophthalmologica. 2002; 216: 305-315
        • Coffey MJ
        • Decory HH
        • Lane SS.
        Development of a non-settling gel formulation of 0.5% loteprednol etabonate for anti-inflammatory use as an ophthalmic drop.
        Clin Ophthalmol. 2013; 7: 299-312
        • Kuno N
        • Fujii S.
        Recent advances in ocular drug delivery systems.
        Polymers. 2011; 3: 193-221
        • Claxton AJ
        • Cramer J
        • Pierce C.
        A systematic review of the associations between dose regimens and medication compliance.
        Clin Ther. 2001; 23: 1296-1310
        • Johannesson G
        • Moya-Ortega MD
        • Asgrimsdottir GM
        • et al.
        Kinetics of gamma-cyclodextrin nanoparticle suspension eye drops in tear fluid.
        Acta Ophthalmol. 2014; 92: 550-556
        • Saari KM
        • Nelimarkka L
        • Ahola V
        • Loftsson T
        • Stefansson E.
        Comparison of topical 0.7% dexamethasone-cyclodextrin with 0.1% dexamethasone sodium phosphate for postcataract inflammation.
        Graefes Arch Clin Exp Ophthalmol. 2006; 244: 620-626
        • Loftsson T
        • Stefansson E.
        Cyclodextrins and topical drug delivery to the anterior and posterior segments of the eye.
        Int J Pharm. 2017; 531: 413-423
        • Sigurdsson HH
        • Konraethsdottir F
        • Loftsson T
        • Stefansson E.
        Topical and systemic absorption in delivery of dexamethasone to the anterior and posterior segments of the eye.
        Acta Ophthalmol Scand. 2007; 85: 598-602
        • Loftsson T
        • Jansook P
        • Stefansson E.
        Topical drug delivery to the eye: dorzolamide.
        Acta Ophthalmol. 2012; 90: 603-608
        • Sripetch S
        • Jansook P
        • Loftsson T.
        Effect of porcine pancreatic alpha-amylase on dexamethasone release from aqueous solution containing natural gamma-cyclodextrin.
        Int J Pharm. 2020; 585119452
        • Jabs DA
        • Nussenblatt RB
        • Rosenbaum JT
        • et al.
        Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop.
        Am J Ophthalmol. 2005; 140: 509-516
        • McCaffrey M
        • Beebe A.
        Pain: clinical manual for nursing practice, Mosby Yearbook.
        Nurs Stand. 1994; 9: 55
        • Shah TJ
        • Conway MD
        • Peyman GA.
        Intracameral dexamethasone injection in the treatment of cataract surgery induced inflammation: design, development, and place in therapy.
        Clin Ophthalmol. 2018; 12: 2223-2235
      1. Durezol [package insert].
        Alcon Laboratories, Inc, Fort Worth, TX2013
      2. Inveltys [package insert].
        Kala Pharmaceuticals, Waltham, MA2018
      3. Lotemax SM [package insert]. Tampa, FL: Bausch & Lomb Inc; 2020.

        • Fong R
        • Silverstein BE
        • Peace JH
        • Williams JI
        • Vittitow JL.
        Submicron loteprednol etabonate ophthalmic gel 0.38% for the treatment of inflammation and pain after cataract surgery.
        J Cataract Refract Surg. 2018; 44: 1220-1229
        • Fong R
        • Cavet ME
        • DeCory HH
        • Vittitow JL.
        Loteprednol etabonate (submicron) ophthalmic gel 0.38% dosed three times daily following cataract surgery: integrated analysis of two Phase III clinical studies.
        Clin Ophthalmol. 2019; 13: 1427-1438
        • Kim T
        • Sall K
        • Holland EJ
        • Brazzell RK
        • Coultas S
        • Gupta PK.
        Safety and efficacy of twice daily administration of KPI-121 1% for ocular inflammation and pain following cataract surgery.
        Clin Ophthalmol. 2019; 13: 69-86
        • Korenfeld MS
        • Silverstein SM
        • Cooke DL
        • et al.
        Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain.
        J Cataract Refract Surg. 2009; 35: 26-34
        • Trattler WB
        • Majmudar PA
        • Donnenfeld ED
        • McDonald MB
        • Stonecipher KG
        • Goldberg DF.
        The Prospective Health Assessment of Cataract Patients' Ocular Surface (PHACO) study: the effect of dry eye.
        Clin Ophthalmol. 2017; 11: 1423-1430
        • Kwon JW
        • Chung YW
        • Choi JA
        • La TY
        • Jee DH
        • Cho YK.
        Comparison of postoperative corneal changes between dry eye and non-dry eye in a murine cataract surgery model.
        Int J Ophthalmol. 2016; 9: 218-224
        • Yu Y
        • Hua H
        • Wu M
        • et al.
        Evaluation of dry eye after femtosecond laser-assisted cataract surgery.
        J Cataract Refract Surg. 2015; 41: 2614-2623
        • Kasetsuwan N
        • Satitpitakul V
        • Changul T
        • Jariyakosol S.
        Incidence and pattern of dry eye after cataract surgery.
        PLOS One. 2013; 8: e78657