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F.W. Price, E. Tonon, A.M. VanDenburgh, K. Stern, J.K. Cheetham, R.M. Schiffman; Safety and Efficacy of Reformulated Ketorolac Tromethamine 0.4% Ophthalmic Solution in Post-Photorefractive Keratectomy Patients . Invest. Ophthalmol. Vis. Sci. 2003;44(13):2611.
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Purpose: Evaluate the safety and analgesic efficacy of reformulated ketorolac 0.4% ophthalmic solution in post-operative unilateral photorefractive keratectomy (PRK) patients. Methods: A multicenter, randomized, double-masked, vehicle-controlled, parallel-group study of 157 patients undergoing unilateral PRK surgery. Patients (79-78/group) were treated with 1 drop of either ketorolac tromethamine ophthalmic solution 0.4% or vehicle QID for up to 4 days. Pain intensity, pain relief, and use of escape medication were assessed every 12 hours for 4 days; severity of ocular symptoms were assessed daily. Adverse events and visual acuity were recorded. Results: Pain intensity was significantly less with ketorolac (P<0.001) for the first 12-hours post-PRK (primary efficacy variable), where the median pain intensity with ketorolac was at least 1 grade less compared with vehicle (5-point scale, 0=no pain to 4=intolerable pain). During the first 12-hours post-PRK the ketorolac group had fewer patients in the severe pain to intolerable pain categories (43.0%, 34/79) compared to the vehicle group (87.2%, 68/78). Ketorolac was superior to vehicle 12-48 hours post-PRK (P≤0.001). During the first 12-hours post-PRK, 44.3% (35/79) of patients in the ketorolac group compared to 7.8% (6/78) of patients in the vehicle group first experienced no pain. Median time to first no pain was achieved by 24 hours in the ketorolac group compared to 54 hours in the vehicle group (P<0.001). During the first 12-hours post-PRK, significantly fewer patients in the ketorolac group (46.8%, 37/79) took escape medication compared to the vehicle group (92.3%, 72/78; P<0.001). Use of escape medication was significantly lower 12-48 hours post-PRK in the ketorolac group compared to the vehicle group (P≤0.006). More ketorolac-treated patients (70.9%, 56/79) than vehicle-treated patients (47.4%, 37/78) reported none to mild burning/stinging on the first day after surgery (P=0.003). Treatment-related adverse events occurred in 2.5% (2/79) of ketorolac-treated patients and 9.0% (7/78) of vehicle-treated patients. One ketorolac-treated patient had corneal infiltrates unrelated to treatment and one vehicle-treated patient had treatment-related corneal infiltrates. Conclusions: Reformulated ketorolac tromethamine ophthalmic solution 0.4% is safe and effective in the treatment of ocular pain, when used QID for up to 4 days post-PRK surgery.
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