Controlled evaluation of loteprednol etabonate and prednisolone acetate in the treatment of acute anterior uveitis

C. R. Cohen, J. Davis, R. DeBarge, J. Foley, C. S. Foster, K. Fox, M. Friedlaender, G. John, A. Kaufman, R. Nozik, K. Olander, C. Ostrov, M. Raizman, James (Jim) Rosenbaum, K. Sall, J. Sheppard, D. Stewart, J. Tauber, S. Trocme, P. Zimmerman

Research output: Contribution to journalArticle

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Abstract

PURPOSE: To compare the safety and efficacy of loteprednol etabonate 0.5% ophthalmic suspension with prednisolone acetate 1.0% ophthalmic suspension in reducing the ocular signs and symptoms associated with acute anterior uveitis. METHODS: Two prospective studies were conducted in sequence. Both were parallel, randomized, doublemasked, active-controlled comparisons conducted at academic or private practice clinics in the United States. Efficacy was evaluated by the proportion of patients with a score of 0 for key signs and symptoms of uveitis. Intraocular pressure was increased regularly. The first study involved up to 42 days of treatment, starting with a dose of eight times per day. The second study involved up to 28 days of treatment, starting with a dose of 16 times per day. RESULTS: In the first study (N = 70), the proportion of patients achieving resolution by the final visit w as anterior chamber cell (74% loteprednol etabonate, 88% prednisolone acetate, P = .194) and flare (71% loteprednol etabonate, 81% prednisolone acetate, P = .330). In the second study (N = 175), the proportion of patients achieving resolution by the final visit was anterior chamber cell (72% loteprednol etabonate, 87% prednisolone acetate, P = .015) and flare (66% loteprednol etabonate, 82% prednisolone acetate, P = .017). In both studies, intraocular pressure increase of more than 10 mm Hg was observed more frequently in patients receiving prednisolone acetate (seven patients) than those receiving loteprednol etabonate (one patient). CONCLUSIONS: Although a clinically meaningful reduction of signs and symptoms was noted in both treatment groups, loteprednol etabonate was less effective than prednisolone acetate in both of these controlled studies. However, the more favorable profile of loteprednol etabonate with respect to intraocular pressure increase may make it useful in many patients.

Original languageEnglish (US)
Pages (from-to)537-544
Number of pages8
JournalAmerican Journal of Ophthalmology
Volume127
Issue number5
DOIs
StatePublished - May 1999
Externally publishedYes

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Anterior Uveitis
Intraocular Pressure
Signs and Symptoms
Anterior Chamber
Therapeutics
Suspensions
prednisolone acetate
Loteprednol Etabonate
Private Practice
Uveitis
Prospective Studies
Safety

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Controlled evaluation of loteprednol etabonate and prednisolone acetate in the treatment of acute anterior uveitis. / Cohen, C. R.; Davis, J.; DeBarge, R.; Foley, J.; Foster, C. S.; Fox, K.; Friedlaender, M.; John, G.; Kaufman, A.; Nozik, R.; Olander, K.; Ostrov, C.; Raizman, M.; Rosenbaum, James (Jim); Sall, K.; Sheppard, J.; Stewart, D.; Tauber, J.; Trocme, S.; Zimmerman, P.

In: American Journal of Ophthalmology, Vol. 127, No. 5, 05.1999, p. 537-544.

Research output: Contribution to journalArticle

Cohen, CR, Davis, J, DeBarge, R, Foley, J, Foster, CS, Fox, K, Friedlaender, M, John, G, Kaufman, A, Nozik, R, Olander, K, Ostrov, C, Raizman, M, Rosenbaum, JJ, Sall, K, Sheppard, J, Stewart, D, Tauber, J, Trocme, S & Zimmerman, P 1999, 'Controlled evaluation of loteprednol etabonate and prednisolone acetate in the treatment of acute anterior uveitis', American Journal of Ophthalmology, vol. 127, no. 5, pp. 537-544. https://doi.org/10.1016/S0002-9394(99)00034-3
Cohen, C. R. ; Davis, J. ; DeBarge, R. ; Foley, J. ; Foster, C. S. ; Fox, K. ; Friedlaender, M. ; John, G. ; Kaufman, A. ; Nozik, R. ; Olander, K. ; Ostrov, C. ; Raizman, M. ; Rosenbaum, James (Jim) ; Sall, K. ; Sheppard, J. ; Stewart, D. ; Tauber, J. ; Trocme, S. ; Zimmerman, P. / Controlled evaluation of loteprednol etabonate and prednisolone acetate in the treatment of acute anterior uveitis. In: American Journal of Ophthalmology. 1999 ; Vol. 127, No. 5. pp. 537-544.
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abstract = "PURPOSE: To compare the safety and efficacy of loteprednol etabonate 0.5{\%} ophthalmic suspension with prednisolone acetate 1.0{\%} ophthalmic suspension in reducing the ocular signs and symptoms associated with acute anterior uveitis. METHODS: Two prospective studies were conducted in sequence. Both were parallel, randomized, doublemasked, active-controlled comparisons conducted at academic or private practice clinics in the United States. Efficacy was evaluated by the proportion of patients with a score of 0 for key signs and symptoms of uveitis. Intraocular pressure was increased regularly. The first study involved up to 42 days of treatment, starting with a dose of eight times per day. The second study involved up to 28 days of treatment, starting with a dose of 16 times per day. RESULTS: In the first study (N = 70), the proportion of patients achieving resolution by the final visit w as anterior chamber cell (74{\%} loteprednol etabonate, 88{\%} prednisolone acetate, P = .194) and flare (71{\%} loteprednol etabonate, 81{\%} prednisolone acetate, P = .330). In the second study (N = 175), the proportion of patients achieving resolution by the final visit was anterior chamber cell (72{\%} loteprednol etabonate, 87{\%} prednisolone acetate, P = .015) and flare (66{\%} loteprednol etabonate, 82{\%} prednisolone acetate, P = .017). In both studies, intraocular pressure increase of more than 10 mm Hg was observed more frequently in patients receiving prednisolone acetate (seven patients) than those receiving loteprednol etabonate (one patient). CONCLUSIONS: Although a clinically meaningful reduction of signs and symptoms was noted in both treatment groups, loteprednol etabonate was less effective than prednisolone acetate in both of these controlled studies. However, the more favorable profile of loteprednol etabonate with respect to intraocular pressure increase may make it useful in many patients.",
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T1 - Controlled evaluation of loteprednol etabonate and prednisolone acetate in the treatment of acute anterior uveitis

AU - Cohen, C. R.

AU - Davis, J.

AU - DeBarge, R.

AU - Foley, J.

AU - Foster, C. S.

AU - Fox, K.

AU - Friedlaender, M.

AU - John, G.

AU - Kaufman, A.

AU - Nozik, R.

AU - Olander, K.

AU - Ostrov, C.

AU - Raizman, M.

AU - Rosenbaum, James (Jim)

AU - Sall, K.

AU - Sheppard, J.

AU - Stewart, D.

AU - Tauber, J.

AU - Trocme, S.

AU - Zimmerman, P.

PY - 1999/5

Y1 - 1999/5

N2 - PURPOSE: To compare the safety and efficacy of loteprednol etabonate 0.5% ophthalmic suspension with prednisolone acetate 1.0% ophthalmic suspension in reducing the ocular signs and symptoms associated with acute anterior uveitis. METHODS: Two prospective studies were conducted in sequence. Both were parallel, randomized, doublemasked, active-controlled comparisons conducted at academic or private practice clinics in the United States. Efficacy was evaluated by the proportion of patients with a score of 0 for key signs and symptoms of uveitis. Intraocular pressure was increased regularly. The first study involved up to 42 days of treatment, starting with a dose of eight times per day. The second study involved up to 28 days of treatment, starting with a dose of 16 times per day. RESULTS: In the first study (N = 70), the proportion of patients achieving resolution by the final visit w as anterior chamber cell (74% loteprednol etabonate, 88% prednisolone acetate, P = .194) and flare (71% loteprednol etabonate, 81% prednisolone acetate, P = .330). In the second study (N = 175), the proportion of patients achieving resolution by the final visit was anterior chamber cell (72% loteprednol etabonate, 87% prednisolone acetate, P = .015) and flare (66% loteprednol etabonate, 82% prednisolone acetate, P = .017). In both studies, intraocular pressure increase of more than 10 mm Hg was observed more frequently in patients receiving prednisolone acetate (seven patients) than those receiving loteprednol etabonate (one patient). CONCLUSIONS: Although a clinically meaningful reduction of signs and symptoms was noted in both treatment groups, loteprednol etabonate was less effective than prednisolone acetate in both of these controlled studies. However, the more favorable profile of loteprednol etabonate with respect to intraocular pressure increase may make it useful in many patients.

AB - PURPOSE: To compare the safety and efficacy of loteprednol etabonate 0.5% ophthalmic suspension with prednisolone acetate 1.0% ophthalmic suspension in reducing the ocular signs and symptoms associated with acute anterior uveitis. METHODS: Two prospective studies were conducted in sequence. Both were parallel, randomized, doublemasked, active-controlled comparisons conducted at academic or private practice clinics in the United States. Efficacy was evaluated by the proportion of patients with a score of 0 for key signs and symptoms of uveitis. Intraocular pressure was increased regularly. The first study involved up to 42 days of treatment, starting with a dose of eight times per day. The second study involved up to 28 days of treatment, starting with a dose of 16 times per day. RESULTS: In the first study (N = 70), the proportion of patients achieving resolution by the final visit w as anterior chamber cell (74% loteprednol etabonate, 88% prednisolone acetate, P = .194) and flare (71% loteprednol etabonate, 81% prednisolone acetate, P = .330). In the second study (N = 175), the proportion of patients achieving resolution by the final visit was anterior chamber cell (72% loteprednol etabonate, 87% prednisolone acetate, P = .015) and flare (66% loteprednol etabonate, 82% prednisolone acetate, P = .017). In both studies, intraocular pressure increase of more than 10 mm Hg was observed more frequently in patients receiving prednisolone acetate (seven patients) than those receiving loteprednol etabonate (one patient). CONCLUSIONS: Although a clinically meaningful reduction of signs and symptoms was noted in both treatment groups, loteprednol etabonate was less effective than prednisolone acetate in both of these controlled studies. However, the more favorable profile of loteprednol etabonate with respect to intraocular pressure increase may make it useful in many patients.

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