J Clin Pharmacol
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CLINICAL STUDIES

Comparison of the Stability, Efficacy, and Adverse Effect Profile of the Innovator 0.005% Latanoprost Ophthalmic Solution and a Novel Cyclodextrin-containing Formulation

Jaime R. Gonzalez, MD, Leopoldo Baiza-Duran, MD, Juan Quintana-Hau, PhD, Ruben Tornero-Montaño, MS, Gilberto Castaneda-Hernandez, MD, PhD, Mario Ortiz, MD, MS, Felipe Alarcon-Oceguera, MD, Marco Beltran-Loustaunau, MD, Marco Cortez-Gastelum, MD, Jorge Garcidueñas-Mejia, MD, Pedro Gomez-Bastar, MD, Jesus Jimenez-Roman, MD, Vincent Korder-Ortega, MD, Jose Paczka-Zapata, MD, Marina Torres-Segura, MD and Gustavo Velasco-Gallegos, MD

From the Clinical Research Department, Laboratorios Sophia, S.A. de C.V., Guadalajara, Mexico (Dr Gonzalez, Dr Baiza-Duran, Dr Quintana-Hau, Mr Tornero-Montaño), Sección de Farmacología, Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional, Mexico City, Mexico (Dr Castaneda-Hernandez), Area Académica de Medicina del Instituto de Ciencias de la Salud, Universidad Autónoma del Estado de Hidalgo, Pachuca, Mexico (Dr Ortiz), and the GAAP Ofteno Multicentric Study Group, Mexico (Dr Alarcon-Oceguera, Dr Beltran-Loustaunau, Dr Cortez-Gastelum, Dr Garcidueñas-Mejia, Dr Gomez-Bastar, Dr Jimenez-Roman, Dr Korder-Ortega, Dr Paczka-Zapata, Dr Torres-Segura, Dr Velasco-Gallegos).

Recently, a new latanoprost ophthalmic solution containing cyclodextrins was developed. The purpose of the present work was to compare the stability, clinical efficacy, and adverse effect profile of this formulation with the innovator product. The innovator formulation was stable at 4°C but exhibited degradation at higher temperatures, whereas the cyclodextrin-containing formulation was stable at temperatures up to 40°C. Formulations were assayed in a randomized double-blind clinical study in patients with primary open-angle glaucoma and/or ocular hypertension. Both latanoprost ophthalmic solutions produced comparable reduction of intraocular pressure. Conjunctival hyperemia was observed in 11.9% and 11.3% of the patients treated with the innovator and the cyclodextrin-containing formulations, respectively. There were no significant differences between the 2 ophthalmic solutions in efficacy or in the measured adverse effect. It is concluded that these 2 latanoprost ophthalmic solutions yield comparable efficacy and adverse effect outcomes. The cyclodextrin-containing formulation, however, has an improved stability.

Key Words: Latanoprost • stability • cyclodextrins • glaucoma • ophthalmic

Address for reprints: Jaime R. Gonzalez, MD, Hidalgo 737 Guadalajara, Jalisco, Mexico ZC 44100; e-mail: invcient{at}sophia.com.mx.




This article has been cited by other articles:


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 J Clin PharmacolHome page
C. S. Tressler and G. W. Bean
Letter to the Editor
J. Clin. Pharmacol., January 1, 2008; 48(1): 123 - 124.
[Full Text] [PDF]

Home page
 J Clin PharmacolHome page
R. J. Gonzalez and G. Castaneda-Hernandez
Authors' Response
J. Clin. Pharmacol., January 1, 2008; 48(1): 125 - 126.
[Full Text] [PDF]


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