Purpose: The aim of this study was to compare the antiinflammatory effect and ocular surface toxicity of topical nonpreserved methylprednisolone sodium succinate 1% and preserved prednisolone acetate suspension 1% for the management of acute anterior uveitis (AAU).
Methods: In this prospective, randomized, investigator-masked, comparative clinical trial, patients with mild-to-moderate noninfectious AAU were assigned randomly to receive either hourly nonpreserved methylprednisolone 1% (group A) or preserved prednisolone 1% (group B) eye drops followed by a 2-week tapering regimen. Anterior chamber cells and flare were clinically evaluated for the objective comparison of the antiinflammatory effect. The main outcome measure was the percentage of patients with a resolution of inflammation (anterior chamber cells <1+) on day 14. Ocular surface toxicity was assessed by means of the corneal fluorescein staining score, tear breakup time, Schirmer I test, and questionnaire-based grading of ocular discomfort parameters.
Results: Seventy-two eyes of 68 patients were studied, of which 38 eyes were enrolled in group A and 34 eyes were enrolled in group B. On day 14, 76.3% of the patients in group A had resolution of inflammation compared with 70.6% of the patients in group B, proving noninferiority (χ2 = 0.303, P = 0.582). The mean anterior chamber cell grade reduction for patients in group A was similar to that in group B (2.52 vs. 2.86, respectively; P = 0.92). Group A patients showed significantly lower corneal fluorescein staining scores (P < 0.001) and reported milder subjective ocular discomfort (0.55 vs. 1.43, P = 0.01) as compared with group B.
Conclusions: Both preparations demonstrated equal antiinflammatory effects for the treatment of AAU. Nonpreserved methylprednisolone eye drops exhibited a significantly lower ocular surface toxicity profile and milder subjective discomfort when compared with that exhibited by preserved prednisolone.
*Noor Ophthalmic Research Center, Noor Eye Hospital, Tehran, Iran;
†Ophthalmology Department, Rassoul Akram Hospital, Iran University of Medical Sciences, Tehran, Iran;
‡Farabi Eye Research Center, Tehran University of Medical Sciences, Tehran, Iran;
§Ocular Inflammation & Immunology Service, Singapore National Eye Centre, Singapore;
¶National University of Singapore, Singapore;
‖Singapore Eye Research Institute, Singapore;
**Duke-National University of Singapore Post Graduate Medical School, Singapore.
Reprints: Alireza Hedayatfar, Ocular Inflammation and Uveitis Clinic, Noor Eye Hospital, 96 Esfandiar Boulevard, Vali'asr Avenue, Tehran 196865311, Iran (e-mail: firstname.lastname@example.org).
The authors have no funding or conflicts of interest to disclose.
Received August 30, 2013
Accepted October 22, 2013