Abstract
Abstract: :
Purpose: To compare the ocular tolerability of the commercially available ophthalmic solutions of the fourth generation fluoroquinolones, gatifloxacin 0.3% (ZymarTM) and moxifloxacin 0.5% (VigamoxTM). Methods: A baseline evaluation was conducted on 30 healthy volunteers for conjunctival hyperemia, conjunctival vascularity, pupil size, and anterior chamber (AC) cell and flare. Pupils were measured with a Colvard pupillometer under scotopic conditions. The conjuctival hyperemia and vascularity, and AC reaction were measured on a scale of 0–3. In a double masked fashion subjects then received random drops in both eyes from masked bottles of gatifloxacin ophthalmic solution 0.3% and moxifloxacin ophthalmic solution 0.5% (placed in either the right or left eye 2 times at a 1 minute interval). After 5 minutes with their eyes closed subjects graded pain and ocular irritation in each eye on a scale of 1–10 and the ophthalmic examination was repeated. Results: Administration of moxifloxacin 0.5% was associated with a statistically significant increase in conjunctival hyperemia (0.21 to 1.52, P = .0005) and conjunctival vascularity (0.55 to 1.61, P = .0005) compared to the gatifloxacin 0.3% associated conjunctival hyperemia (0.22 to 0.45) and conjunctival vascularity (0.52 to 0.68) at 5 min. There was significantly less pain (1.2 vs. 3.2, P = .001) and irritation (0.64 vs. 3.42, P = .001) with gatifloxacin 0.3% administration than with moxifloxacin 0.5%. There was a significant reduction in pupil size (5.65 mm to 5.05 mm) in eyes which received moxifloxacin 0.5% (P = .004) and no significant change in pupil size (5.60 mm to 5.65 mm) in eyes which received gatifloxacin 0.3% (P = .878). There was no AC reaction noted with either medication. Conclusions: Gatifloxacin 0.3% demonstrated statistically significantly greater ocular tolerability compared to moxifloxacin 0.5%.
Keywords: antibiotics/antifungals/antiparasitics • clinical research methodology • pharmacology