PURPOSE: To determine acceptability and efficacy of hydroxypropyl cellulose ophthalmic inserts in patients with dry eye syndrome (DES) and additional comorbidities. DESIGN: A multicenter, 2-visit, open-label, 4-week registry study. PARTICIPANTS: Five hundred twenty patients were recruited to the intent-to-treat group. Four hundred eighteen patients completed the study including 86 contact lens wearers, 79 with cataract diagnosis, 52 with prior cataract surgery, 22 with prior laser-assisted in situ keratomileusis, and 15 with glaucoma. METHODS: Patient questionnaires were completed at baseline and after 4 weeks of treatment to assess mean change in severity of DES symptoms, ocular surface disease index (OSDI) scores, frequency of occurrence of DES symptoms, occurrence of difficulty when performing activities of daily living (ADLs), and frequency of discomfort in various environmental conditions. Mean change was measured from visit 1 to visit 2. MAIN OUTCOME MEASURES: Symptoms, OSDI scores, and measure of degree of difficulty when performing ADLs. RESULTS: Four hundred eighteen patients completed the study. Compared with baseline, this population of patients demonstrated statistically significant improvements in mean OSDI scores (P = 0.0215) and symptoms of discomfort, burning, dryness, grittiness, stinging, and light sensitivity (P < 0.05). Mean improvement in OSDI scores of patients in the 5 identified subsets of patients with comorbid conditions were significant for patients using contact lenses (P < 0.025), who had undergone prior cataract surgery (P < 0.04), and with prior laser-assisted in situ keratomileusis surgery (P < 0.05). Patients diagnosed with cataracts or glaucoma did not show significant changes in any measures in this study. Patients with DES and comorbid conditions experienced relief of symptoms and benefit to ADLs and quality of life similar to patients without comorbid conditions. CONCLUSIONS: In subsets of patients with moderate to severe DES and comorbid conditions, hydroxypropyl cellulose ophthalmic inserts improve the symptoms of DES, ability to perform ADLs, and quality of life. The reported benefits may be additive to those seen with patients' existing therapies.
PURPOSE: To determine acceptability and efficacy of hydroxypropyl cellulose ophthalmic inserts in patients with dry eye syndrome (DES) and additional comorbidities. DESIGN: A multicenter, 2-visit, open-label, 4-week registry study. PARTICIPANTS: Five hundred twenty patients were recruited to the intent-to-treat group. Four hundred eighteen patients completed the study including 86 contact lens wearers, 79 with cataract diagnosis, 52 with prior cataract surgery, 22 with prior laser-assisted in situ keratomileusis, and 15 with glaucoma. METHODS:Patient questionnaires were completed at baseline and after 4 weeks of treatment to assess mean change in severity of DES symptoms, ocular surface disease index (OSDI) scores, frequency of occurrence of DES symptoms, occurrence of difficulty when performing activities of daily living (ADLs), and frequency of discomfort in various environmental conditions. Mean change was measured from visit 1 to visit 2. MAIN OUTCOME MEASURES: Symptoms, OSDI scores, and measure of degree of difficulty when performing ADLs. RESULTS: Four hundred eighteen patients completed the study. Compared with baseline, this population of patients demonstrated statistically significant improvements in mean OSDI scores (P = 0.0215) and symptoms of discomfort, burning, dryness, grittiness, stinging, and light sensitivity (P < 0.05). Mean improvement in OSDI scores of patients in the 5 identified subsets of patients with comorbid conditions were significant for patients using contact lenses (P < 0.025), who had undergone prior cataract surgery (P < 0.04), and with prior laser-assisted in situ keratomileusis surgery (P < 0.05). Patients diagnosed with cataracts or glaucoma did not show significant changes in any measures in this study. Patients with DES and comorbid conditions experienced relief of symptoms and benefit to ADLs and quality of life similar to patients without comorbid conditions. CONCLUSIONS: In subsets of patients with moderate to severe DES and comorbid conditions, hydroxypropyl cellulose ophthalmic inserts improve the symptoms of DES, ability to perform ADLs, and quality of life. The reported benefits may be additive to those seen with patients' existing therapies.
Authors: Penny A Asbell; Maureen G Maguire; Ellen Peskin; Vatinee Y Bunya; Eric J Kuklinski Journal: Contemp Clin Trials Date: 2018-06-06 Impact factor: 2.226
Authors: Mark S Milner; Kenneth A Beckman; Jodi I Luchs; Quentin B Allen; Richard M Awdeh; John Berdahl; Thomas S Boland; Carlos Buznego; Joseph P Gira; Damien F Goldberg; David Goldman; Raj K Goyal; Mitchell A Jackson; James Katz; Terry Kim; Parag A Majmudar; Ranjan P Malhotra; Marguerite B McDonald; Rajesh K Rajpal; Tal Raviv; Sheri Rowen; Neda Shamie; Jonathan D Solomon; Karl Stonecipher; Shachar Tauber; William Trattler; Keith A Walter; George O Waring; Robert J Weinstock; William F Wiley; Elizabeth Yeu Journal: Curr Opin Ophthalmol Date: 2017-01 Impact factor: 3.761