A phase III clinical trial of 0.5% levofloxacin ophthalmic solution versus 0.3% ofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis

Ivan R. Schwab, Mitchell Friedlaender, James McCulley, Steven J. Lichtenstein, C. Thomas Moran, Mark Abelson, Gavin Bahadur, Richard Braunstein, Robert Caine, Timothy Cavanaugh, Steven Dell, Peter Donshik, Norman Levy, Bernard Milstein, Thomas Mundorf, Terrence O'Brien, Steven Prepas, Robert Reidy, Kenneth Sall, Alan SugarShailaja Valluri, Francis Wapner, Thomas Wolf

Research output: Contribution to journalArticle

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Abstract

Objective: To compare the efficacy and safety of 0.5% levofloxacin ophthalmic solution (QUIXIN) with 0.3% ofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis. Design: Prospective, randomized, active-controlled, double-masked, multicenter study. Participants: Four hundred twenty-three patients with a clinical diagnosis of bacterial conjunctivitis were enrolled. Methods: Patients were randomly assigned to receive either 0.5% levofloxacin (n = 211) or 0.3% ofloxacin (n = 212) for 5 days (every 2 hours on days 1 and 2 and every 4 hours on days 3-5). Conjunctival cultures were obtained, and ocular signs and symptoms were evaluated on day 1 (baseline), days 3 to 5 (interim), and days 6 to 10 (final). End point was defined as the last evaluable observation. Main Outcome Measures: Primary microbial and clinical outcomes were based on culture results and resolution of cardinal signs, respectively. Secondary efficacy assessments included evaluations of ocular signs and symptoms. Results: Two hundred eight patients (levofloxacin, n = 109; ofloxacin, n = 99) were evaluated for efficacy. Microbial eradication rates were significantly greater in the 0.5% levofloxacin treatment group compared with the 0.3% ofloxacin group at both the final visit (89% vs. 80%, P = 0.034) and at end point (90% vs. 81%; P = 0.038). Treatment with 0.5% levofloxacin was significantly more effective in resolving photophobia than was 0.3% ofloxacin treatment (94% vs. 73%, P = 0.006). Both study medications were well tolerated, with a low incidence of adverse events. Conclusions: Although clinical cure rates in the 0.5% levofloxacin and 0.3% ofloxacin treatment groups were similar, a 5-day treatment regimen with 0.5% levofloxacin achieved microbial eradication rates that were statistically superior to those attained with 0.3% ofloxacin. Despite the higher concentration of active drug in 0.5% levofloxacin versus 0.3% ofloxacin, there was no difference between treatment groups in the incidence of treatment-related adverse events.

Original languageEnglish
Pages (from-to)457-465
Number of pages9
JournalOphthalmology
Volume110
Issue number3
DOIs
StatePublished - Mar 1 2003
Externally publishedYes

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Bacterial Conjunctivitis
Phase III Clinical Trials
Levofloxacin
Ofloxacin
Ophthalmic Solutions
Therapeutics
Signs and Symptoms
Photophobia
Incidence
Double-Blind Method
Multicenter Studies
Observation
Outcome Assessment (Health Care)
Safety

ASJC Scopus subject areas

  • Ophthalmology

Cite this

A phase III clinical trial of 0.5% levofloxacin ophthalmic solution versus 0.3% ofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis. / Schwab, Ivan R.; Friedlaender, Mitchell; McCulley, James; Lichtenstein, Steven J.; Moran, C. Thomas; Abelson, Mark; Bahadur, Gavin; Braunstein, Richard; Caine, Robert; Cavanaugh, Timothy; Dell, Steven; Donshik, Peter; Levy, Norman; Milstein, Bernard; Mundorf, Thomas; O'Brien, Terrence; Prepas, Steven; Reidy, Robert; Sall, Kenneth; Sugar, Alan; Valluri, Shailaja; Wapner, Francis; Wolf, Thomas.

In: Ophthalmology, Vol. 110, No. 3, 01.03.2003, p. 457-465.

Research output: Contribution to journalArticle

Schwab, IR, Friedlaender, M, McCulley, J, Lichtenstein, SJ, Moran, CT, Abelson, M, Bahadur, G, Braunstein, R, Caine, R, Cavanaugh, T, Dell, S, Donshik, P, Levy, N, Milstein, B, Mundorf, T, O'Brien, T, Prepas, S, Reidy, R, Sall, K, Sugar, A, Valluri, S, Wapner, F & Wolf, T 2003, 'A phase III clinical trial of 0.5% levofloxacin ophthalmic solution versus 0.3% ofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis', Ophthalmology, vol. 110, no. 3, pp. 457-465. https://doi.org/10.1016/S0161-6420(02)01894-8
Schwab, Ivan R. ; Friedlaender, Mitchell ; McCulley, James ; Lichtenstein, Steven J. ; Moran, C. Thomas ; Abelson, Mark ; Bahadur, Gavin ; Braunstein, Richard ; Caine, Robert ; Cavanaugh, Timothy ; Dell, Steven ; Donshik, Peter ; Levy, Norman ; Milstein, Bernard ; Mundorf, Thomas ; O'Brien, Terrence ; Prepas, Steven ; Reidy, Robert ; Sall, Kenneth ; Sugar, Alan ; Valluri, Shailaja ; Wapner, Francis ; Wolf, Thomas. / A phase III clinical trial of 0.5% levofloxacin ophthalmic solution versus 0.3% ofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis. In: Ophthalmology. 2003 ; Vol. 110, No. 3. pp. 457-465.
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abstract = "Objective: To compare the efficacy and safety of 0.5{\%} levofloxacin ophthalmic solution (QUIXIN) with 0.3{\%} ofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis. Design: Prospective, randomized, active-controlled, double-masked, multicenter study. Participants: Four hundred twenty-three patients with a clinical diagnosis of bacterial conjunctivitis were enrolled. Methods: Patients were randomly assigned to receive either 0.5{\%} levofloxacin (n = 211) or 0.3{\%} ofloxacin (n = 212) for 5 days (every 2 hours on days 1 and 2 and every 4 hours on days 3-5). Conjunctival cultures were obtained, and ocular signs and symptoms were evaluated on day 1 (baseline), days 3 to 5 (interim), and days 6 to 10 (final). End point was defined as the last evaluable observation. Main Outcome Measures: Primary microbial and clinical outcomes were based on culture results and resolution of cardinal signs, respectively. Secondary efficacy assessments included evaluations of ocular signs and symptoms. Results: Two hundred eight patients (levofloxacin, n = 109; ofloxacin, n = 99) were evaluated for efficacy. Microbial eradication rates were significantly greater in the 0.5{\%} levofloxacin treatment group compared with the 0.3{\%} ofloxacin group at both the final visit (89{\%} vs. 80{\%}, P = 0.034) and at end point (90{\%} vs. 81{\%}; P = 0.038). Treatment with 0.5{\%} levofloxacin was significantly more effective in resolving photophobia than was 0.3{\%} ofloxacin treatment (94{\%} vs. 73{\%}, P = 0.006). Both study medications were well tolerated, with a low incidence of adverse events. Conclusions: Although clinical cure rates in the 0.5{\%} levofloxacin and 0.3{\%} ofloxacin treatment groups were similar, a 5-day treatment regimen with 0.5{\%} levofloxacin achieved microbial eradication rates that were statistically superior to those attained with 0.3{\%} ofloxacin. Despite the higher concentration of active drug in 0.5{\%} levofloxacin versus 0.3{\%} ofloxacin, there was no difference between treatment groups in the incidence of treatment-related adverse events.",
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T1 - A phase III clinical trial of 0.5% levofloxacin ophthalmic solution versus 0.3% ofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis

AU - Schwab, Ivan R.

AU - Friedlaender, Mitchell

AU - McCulley, James

AU - Lichtenstein, Steven J.

AU - Moran, C. Thomas

AU - Abelson, Mark

AU - Bahadur, Gavin

AU - Braunstein, Richard

AU - Caine, Robert

AU - Cavanaugh, Timothy

AU - Dell, Steven

AU - Donshik, Peter

AU - Levy, Norman

AU - Milstein, Bernard

AU - Mundorf, Thomas

AU - O'Brien, Terrence

AU - Prepas, Steven

AU - Reidy, Robert

AU - Sall, Kenneth

AU - Sugar, Alan

AU - Valluri, Shailaja

AU - Wapner, Francis

AU - Wolf, Thomas

PY - 2003/3/1

Y1 - 2003/3/1

N2 - Objective: To compare the efficacy and safety of 0.5% levofloxacin ophthalmic solution (QUIXIN) with 0.3% ofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis. Design: Prospective, randomized, active-controlled, double-masked, multicenter study. Participants: Four hundred twenty-three patients with a clinical diagnosis of bacterial conjunctivitis were enrolled. Methods: Patients were randomly assigned to receive either 0.5% levofloxacin (n = 211) or 0.3% ofloxacin (n = 212) for 5 days (every 2 hours on days 1 and 2 and every 4 hours on days 3-5). Conjunctival cultures were obtained, and ocular signs and symptoms were evaluated on day 1 (baseline), days 3 to 5 (interim), and days 6 to 10 (final). End point was defined as the last evaluable observation. Main Outcome Measures: Primary microbial and clinical outcomes were based on culture results and resolution of cardinal signs, respectively. Secondary efficacy assessments included evaluations of ocular signs and symptoms. Results: Two hundred eight patients (levofloxacin, n = 109; ofloxacin, n = 99) were evaluated for efficacy. Microbial eradication rates were significantly greater in the 0.5% levofloxacin treatment group compared with the 0.3% ofloxacin group at both the final visit (89% vs. 80%, P = 0.034) and at end point (90% vs. 81%; P = 0.038). Treatment with 0.5% levofloxacin was significantly more effective in resolving photophobia than was 0.3% ofloxacin treatment (94% vs. 73%, P = 0.006). Both study medications were well tolerated, with a low incidence of adverse events. Conclusions: Although clinical cure rates in the 0.5% levofloxacin and 0.3% ofloxacin treatment groups were similar, a 5-day treatment regimen with 0.5% levofloxacin achieved microbial eradication rates that were statistically superior to those attained with 0.3% ofloxacin. Despite the higher concentration of active drug in 0.5% levofloxacin versus 0.3% ofloxacin, there was no difference between treatment groups in the incidence of treatment-related adverse events.

AB - Objective: To compare the efficacy and safety of 0.5% levofloxacin ophthalmic solution (QUIXIN) with 0.3% ofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis. Design: Prospective, randomized, active-controlled, double-masked, multicenter study. Participants: Four hundred twenty-three patients with a clinical diagnosis of bacterial conjunctivitis were enrolled. Methods: Patients were randomly assigned to receive either 0.5% levofloxacin (n = 211) or 0.3% ofloxacin (n = 212) for 5 days (every 2 hours on days 1 and 2 and every 4 hours on days 3-5). Conjunctival cultures were obtained, and ocular signs and symptoms were evaluated on day 1 (baseline), days 3 to 5 (interim), and days 6 to 10 (final). End point was defined as the last evaluable observation. Main Outcome Measures: Primary microbial and clinical outcomes were based on culture results and resolution of cardinal signs, respectively. Secondary efficacy assessments included evaluations of ocular signs and symptoms. Results: Two hundred eight patients (levofloxacin, n = 109; ofloxacin, n = 99) were evaluated for efficacy. Microbial eradication rates were significantly greater in the 0.5% levofloxacin treatment group compared with the 0.3% ofloxacin group at both the final visit (89% vs. 80%, P = 0.034) and at end point (90% vs. 81%; P = 0.038). Treatment with 0.5% levofloxacin was significantly more effective in resolving photophobia than was 0.3% ofloxacin treatment (94% vs. 73%, P = 0.006). Both study medications were well tolerated, with a low incidence of adverse events. Conclusions: Although clinical cure rates in the 0.5% levofloxacin and 0.3% ofloxacin treatment groups were similar, a 5-day treatment regimen with 0.5% levofloxacin achieved microbial eradication rates that were statistically superior to those attained with 0.3% ofloxacin. Despite the higher concentration of active drug in 0.5% levofloxacin versus 0.3% ofloxacin, there was no difference between treatment groups in the incidence of treatment-related adverse events.

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