Rei Sakata1, Toshihiro Sakisaka1, Hiroshi Matsuo2, Kazunori Miyata3, Makoto Aihara1. 1. 1 Department of Ophthalmology, University of Tokyo School of Medicine, Tokyo, Japan . 2. 2 Matsuo Eye Clinic, Tokyo, Japan . 3. 3 Department of Ophthalmology, Miyata Eye Hospital , Miyazaki, Japan .
Abstract
PURPOSE: The main purpose was to determine whether a nonsteroidal anti-inflammatory drug (NSAID) ophthalmic solution would affect the intraocular pressure (IOP)-lowering effect of a benzalkonium chloride (BAK)-free prostaglandin analog, travoprost. The secondary purpose was to confirm the IOP-lowering effect of BAK-free travoprost on the diurnal IOP. METHODS: This was a prospective, randomized, double-blind, placebo-controlled 1-month trial. After baseline diurnal IOP was confirmed, travoprost was administered once daily to both eyes. Bromfenac sodium hydrate was then randomly assigned to one eye, while flavin adenine dinucleotide sodium was applied to the other eye as a control. Both solutions were administered twice daily. IOP was measured three times daily (8:00, 14:00, and 20:00). The IOP of both groups was compared using Student's t-test. The effect of NSAID on IOP was investigated by repeated measures analysis of variance (ANOVA). RESULTS:Twenty-eight normal Japanese subjects (mean age, 36.6 years) completed the study. After the start of travoprost, remarkable IOP lowering was gained and it settled to 10-11 mmHg. The diurnal IOPs of the NSAID group showed similar tendencies to that of the control group (P = 0.69-1.0). In a 1-month period, the range of IOP reductions compared with the baseline IOP of both groups showed no significant difference (P = 0.76-0.92). NSAID did not have an influence on IOP (F-value = 0.0036, P = 0.95). CONCLUSIONS: Although BAK-free travoprost showed a powerful IOP-lowering effect in diurnal and 1-month readings, even in eyes with an IOP of <13 mmHg, the NSAIDophthalmic solution did not affect its IOP-lowering effect.
RCT Entities:
PURPOSE: The main purpose was to determine whether a nonsteroidal anti-inflammatory drug (NSAID) ophthalmic solution would affect the intraocular pressure (IOP)-lowering effect of a benzalkonium chloride (BAK)-free prostaglandin analog, travoprost. The secondary purpose was to confirm the IOP-lowering effect of BAK-free travoprost on the diurnal IOP. METHODS: This was a prospective, randomized, double-blind, placebo-controlled 1-month trial. After baseline diurnal IOP was confirmed, travoprost was administered once daily to both eyes. Bromfenac sodium hydrate was then randomly assigned to one eye, while flavin adenine dinucleotide sodium was applied to the other eye as a control. Both solutions were administered twice daily. IOP was measured three times daily (8:00, 14:00, and 20:00). The IOP of both groups was compared using Student's t-test. The effect of NSAID on IOP was investigated by repeated measures analysis of variance (ANOVA). RESULTS: Twenty-eight normal Japanese subjects (mean age, 36.6 years) completed the study. After the start of travoprost, remarkable IOP lowering was gained and it settled to 10-11 mmHg. The diurnal IOPs of the NSAID group showed similar tendencies to that of the control group (P = 0.69-1.0). In a 1-month period, the range of IOP reductions compared with the baseline IOP of both groups showed no significant difference (P = 0.76-0.92). NSAID did not have an influence on IOP (F-value = 0.0036, P = 0.95). CONCLUSIONS: Although BAK-free travoprost showed a powerful IOP-lowering effect in diurnal and 1-month readings, even in eyes with an IOP of <13 mmHg, the NSAID ophthalmic solution did not affect its IOP-lowering effect.