Comparison of the stability, efficacy, and adverse effect profile of the innovator 0.005% latanoprost ophthalmic solution and a novel cyclodextrin-containing formulation.
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 degrees C but exhibited degradation at higher temperatures, whereas the cyclodextrin-containing formulation was stable at temperatures up to 40 degrees 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.
Gonzalez
Jaime R
JR
Clinical Research Department, Laboratorios Sophia, S.A. de C.V., Guadalajara, Mexico. invcient@sophia.com.mx
Baiza-Duran
Leopoldo
L
Quintana-Hau
Juan
J
Tornero-Montaño
Ruben
R
Castaneda-Hernandez
Gilberto
G
Ortiz
Mario
M
Alarcon-Oceguera
Felipe
F
Beltran-Loustaunau
Marco
M
Cortez-Gastelum
Marco
M
Garcidueñas-Mejia
Jorge
J
Gomez-Bastar
Pedro
P
Jimenez-Roman
Jesus
J
Korder-Ortega
Vincent
V
Paczka-Zapata
Jose
J
Torres-Segura
Marina
M
Velasco-Gallegos
Gustavo
G
D000368:Aged; D003228:Conjunctiva / Q000098:blood supply / Q000473:pathology; D003505:Cyclodextrins / Q000737:chemistry*; D004311:Double-Blind Method; D004355:Drug Stability; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy; D006801:Humans; D006940:Hyperemia / Q000139:chemically induced*; D000077338:Latanoprost; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy; D009883:Ophthalmic Solutions; D011461:Prostaglandins F, Synthetic / Q000009:adverse effects* / Q000737:chemistry / Q000627:therapeutic use*; D013696:Temperature
D003505:Cyclodextrins; D009883:Ophthalmic Solutions; D011461:Prostaglandins F, Synthetic; D000077338:Latanoprost