Christophe Baudouin1, David J Galarreta2, Ewa Mrukwa-Kominek3, Daniel Böhringer4, Vincenzo Maurino5, Michel Guillon6, Gemma C M Rossi7, Ivanka J Van der Meulen8, Abayomi Ogundele9, Marc Labetoulle10. 1. Quinze-Vingts National Ophthalmology Hospital, INSERM-DHOS CIC 1423, Paris - France. 2. University Clinic Hospital of Valladolid, Valladolid - Spain. 3. University Center of Ophthalmology and Oncology, Silesian University of Medicine, Katowice - Poland. 4. Eye Center, University Hospital Freiburg, Freiburg - Germany. 5. Moorfields Eye Hospital, London - UK. 6. Ocular Technology Group-International, London - UK. 7. Clinica Oculistica IRCCS-Policlinico San Matteo, Pavia - Italy. 8. Academic Medical Center, Amsterdam - The Netherlands. 9. Alcon Research, Ltd., Fort Worth, TX - USA. 10. Ophthalmology Department, Bicêtre University Hospital, South Paris University, Kremlin-Bicêtre - France.
Abstract
PURPOSE: To evaluate and compare the efficacy of a lipid-based lubricant eyedrop formulation (hydroxypropyl guar/propylene glycol/phospholipid [HPG/PG/PL]) with preservative-free saline for the treatment of dry eye. METHODS: This was a prospective, multicenter, randomized, single-masked, parallel-group phase 4 clinical study. Patients ≥18 years diagnosed with dry eye received 1 drop of saline 4 times daily (QID) for 15 days during a run-in phase, followed by randomization. Patients then instilled HPG/PG/PL or saline QID through day 35 and as needed through day 90. Change in tear film break-up time (TFBUT), change in total ocular surface staining (TOSS) score, and Impact of Dry Eye on Everyday Life (IDEEL) were evaluated on day 35. RESULTS:Increase in TFBUT from baseline to day 35 was assessed during the interim and final analyses. Mean ± SE difference between the HPG/PG/PL (n = 110) and saline groups (n = 100) was 1.3 ± 0.4 seconds (interim analysis; 95% confidence interval [CI] 0.5-2.1 seconds; p = 0.0012) and 1.0 ± 0.3 seconds (final analysis; 95% CI 0.4-1.6 seconds; p = 0.0011), demonstrating the superiority of HPG/PG/PL. The mean ± SE difference between the HPG/PG/PL and saline groups for IDEEL treatment effectiveness scores was 16.0 ± 3.6 (95% CI 8.9-23.1; p<0.0001). No significant differences in TOSS scores or IDEEL inconvenience scores were observed between treatment groups. CONCLUSIONS: Thirty-five days of QID HPG/PG/PL treatment resulted in a statistically significant improvement in TFBUT and IDEEL treatment effectiveness scores compared with saline but not in TOSS or IDEEL treatment inconvenience scores. HPG/PG/PL was well-tolerated by patients.
RCT Entities:
PURPOSE: To evaluate and compare the efficacy of a lipid-based lubricant eyedrop formulation (hydroxypropyl guar/propylene glycol/phospholipid [HPG/PG/PL]) with preservative-free saline for the treatment of dry eye. METHODS: This was a prospective, multicenter, randomized, single-masked, parallel-group phase 4 clinical study. Patients ≥18 years diagnosed with dry eye received 1 drop of saline 4 times daily (QID) for 15 days during a run-in phase, followed by randomization. Patients then instilled HPG/PG/PL or saline QID through day 35 and as needed through day 90. Change in tear film break-up time (TFBUT), change in total ocular surface staining (TOSS) score, and Impact of Dry Eye on Everyday Life (IDEEL) were evaluated on day 35. RESULTS: Increase in TFBUT from baseline to day 35 was assessed during the interim and final analyses. Mean ± SE difference between the HPG/PG/PL (n = 110) and saline groups (n = 100) was 1.3 ± 0.4 seconds (interim analysis; 95% confidence interval [CI] 0.5-2.1 seconds; p = 0.0012) and 1.0 ± 0.3 seconds (final analysis; 95% CI 0.4-1.6 seconds; p = 0.0011), demonstrating the superiority of HPG/PG/PL. The mean ± SE difference between the HPG/PG/PL and saline groups for IDEEL treatment effectiveness scores was 16.0 ± 3.6 (95% CI 8.9-23.1; p<0.0001). No significant differences in TOSS scores or IDEEL inconvenience scores were observed between treatment groups. CONCLUSIONS: Thirty-five days of QID HPG/PG/PL treatment resulted in a statistically significant improvement in TFBUT and IDEEL treatment effectiveness scores compared with saline but not in TOSS or IDEEL treatment inconvenience scores. HPG/PG/PL was well-tolerated by patients.
Authors: Gary Jerkins; Jack V Greiner; Louis Tong; Jacqueline Tan; Joseph Tauber; Ali Mearza; Sruthi Srinivasan Journal: Clin Ophthalmol Date: 2020-06-18
Authors: Marc Labetoulle; Stefanie Schmickler; David Galarreta; Daniel Böhringer; Abayomi Ogundele; Michel Guillon; Christophe Baudouin Journal: Clin Ophthalmol Date: 2018-12-05