Kathy Dumbleton1, Craig Woods, Desmond Fonn. 1. Centre for Contact Lens Research, School of Optometry, University of Waterloo, Waterloo, Canada. kdumble@uwaterloo.ca
Abstract
OBJECTIVE: To investigate the efficacy of a novel ocular lubricant compared with a commercially marketed ocular lubricant in a group of noncontact lens wearers currently using over-the-counter products for the management of symptoms of moderate to severe dry eye. METHODS: This was a prospective, double-masked study that randomized 110 subjects in a ratio of 1:1 to receive anovel ocular lubricant (test group) or a marketed ocular lubricant (control group). Subjects were instructed to instill the lubricant eye drops at least three times daily. After enrollment, subjects were evaluated at baseline and at 7 and 30 days. They were also required to complete a series of home-based subjective questionnaires after 15 days. Main outcomes were subjective symptoms and objective clinical assessment at 7 and 30 days. RESULTS: The test group had higher overall comfort ratings than the control group (P = 0.012). Seventy-one percent of the test group and 57% of the control group said the drops used "somewhat" or "definitely" improved ocular comfort; 62% of the test group had greater end-of-day comfort compared with 45% of the control group (P = 0.015). There were no between-group differences in visual acuity, tear quality or quantity, corneal staining, conjunctival staining, or bulbar and limbal conjunctival hyperemia. CONCLUSIONS: The novel ocular lubricant offers equivalent or superior comfort compared with a marketed lubricant eye drop. Objective clinical outcomes were not statistically significantly different between the two groups.
RCT Entities:
OBJECTIVE: To investigate the efficacy of a novel ocular lubricant compared with a commercially marketed ocular lubricant in a group of noncontact lens wearers currently using over-the-counter products for the management of symptoms of moderate to severe dry eye. METHODS: This was a prospective, double-masked study that randomized 110 subjects in a ratio of 1:1 to receive a novel ocular lubricant (test group) or a marketed ocular lubricant (control group). Subjects were instructed to instill the lubricant eye drops at least three times daily. After enrollment, subjects were evaluated at baseline and at 7 and 30 days. They were also required to complete a series of home-based subjective questionnaires after 15 days. Main outcomes were subjective symptoms and objective clinical assessment at 7 and 30 days. RESULTS: The test group had higher overall comfort ratings than the control group (P = 0.012). Seventy-one percent of the test group and 57% of the control group said the drops used "somewhat" or "definitely" improved ocular comfort; 62% of the test group had greater end-of-day comfort compared with 45% of the control group (P = 0.015). There were no between-group differences in visual acuity, tear quality or quantity, corneal staining, conjunctival staining, or bulbar and limbal conjunctival hyperemia. CONCLUSIONS: The novel ocular lubricant offers equivalent or superior comfort compared with a marketed lubricant eye drop. Objective clinical outcomes were not statistically significantly different between the two groups.
Authors: Rohan Bir Singh; Lingjia Liu; Ann Yung; Sonia Anchouche; Sharad K Mittal; Tomas Blanco; Thomas H Dohlman; Jia Yin; Reza Dana Journal: Ocul Surf Date: 2021-05-15 Impact factor: 6.268
Authors: Nasir Saeed; Za Qazi; Nadeem H Butt; Ahson Siddiqi; Neeta Maheshwary; Muhammad Athar Khan Journal: Pak J Med Sci Date: 2013-07 Impact factor: 1.088