title: Incidence of new coding for dry eye and ocular infection in open-angle glaucoma and ocular hypertension patients treated with prostaglandin analogs: retrospective analysis of three medical/pharmacy claims databases.
abstract: BACKGROUND
  To investigate the clinical relevance of two different preservative formulations, we compared 1-year incidence rates of additional coding of dry eye, ocular infection, or ocular surface disease (either dry eye or ocular infection) in open-angle glaucoma and ocular hypertension patients newly treated with latanoprost with benzalkonium chloride (BAK) or with travoprost-Z with SofZia®.
  
  
  METHODS
  This was a retrospective study of three U.S.-based patient-centric medical/pharmacy claims databases (MedStat, PharMetrics, i3-Ingenix). Patients were eligible if they filled a prescription for latanoprost or travoprost-Z between October 2006 and Q2 2008 (prescription date = index date) AND were continuously enrolled 6 months prior through 12 months after the index date AND had any open-angle glaucoma or ocular hypertension diagnosis within 90 days prior to the index date AND did not have an ocular surface disease diagnosis during the 180 days prior to the index date AND if they had not had a prescription for the index agent in the 180 days prior to the index date. Time to incidence of new coding for ocular surface disease in the first year post-index was estimated with a composite endpoint: diagnosis of dry eye or ocular infection by ICD-9-CM or Current Procedural Terminology code OR by prescription for cyclosporine ophthalmic emulsion or ocular antibiotics.
  
  
  RESULTS
  In all, 15,933 patients were treated with latanoprost and 7670 with travoprost-Z. Over 1 year, 4.3% of latanoprost and 4.5% of travoprost-Z patients were identified with dry eye (p = 0.28), and 10.9% and 11.1%, respectively, were identified with an ocular infection (p = 0.79). The 1-year incidence of new coding for ocular surface disease also was similar across treatments (13.9% vs 14.3%, respectively; p = 0.48).
  
  
  CONCLUSIONS
  The retrospective analysis of three large prescription databases revealed that open-angle glaucoma and ocular hypertension patients newly treated with latanoprost preserved with BAK or travoprost-Z preserved with SofZia did not differ statistically in rates of dry eye, ocular infection, or ocular surface disease (either dry eye or ocular infection) during the first year post-index. Claims-based analyses are limited by nonrandomization and the inability to account for over-the-counter use or samples.
authors.affiliation: Glaucoma Consultants, Greater Baltimore Medical Center; Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland, USA. schwartzgf@aol.com
authors.forename: Gail F
authors.initials: GF
authors.lastname: Schwartz
authors.forename: Sameer
authors.initials: S
authors.lastname: Kotak
authors.forename: Jack
authors.initials: J
authors.lastname: Mardekian
authors.forename: Joel M
authors.initials: JM
authors.lastname: Fain
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use; D001548:Benzalkonium Compounds; D003008:Cloprostenol / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D039702:Current Procedural Terminology; D016208:Databases, Factual; D015352:Dry Eye Syndromes / Q000139:chemically induced*; D015817:Eye Infections / Q000139:chemically induced*; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy*; D006801:Humans; D038801:International Classification of Diseases; D053208:Kaplan-Meier Estimate; D000077338:Latanoprost; D008297:Male; D008511:Medicine; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy*; D009883:Ophthalmic Solutions; D010604:Pharmacy; D055656:Prescriptions; D011310:Preservatives, Pharmaceutical; D011461:Prostaglandins F, Synthetic / Q000009:adverse effects / Q000627:therapeutic use; D011465:Prostaglandins, Synthetic / Q000009:adverse effects* / Q000627:therapeutic use*; D012189:Retrospective Studies; D000069557:Travoprost
chemical_list: D000959:Antihypertensive Agents; D001548:Benzalkonium Compounds; D009883:Ophthalmic Solutions; D011310:Preservatives, Pharmaceutical; D011461:Prostaglandins F, Synthetic; D011465:Prostaglandins, Synthetic; D003008:Cloprostenol; D000077338:Latanoprost; D000069557:Travoprost