July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
Efficacy and tolerability of a preservative-free triple fixed combination in glaucoma patients: a prospective crossover study
Author Affiliations & Notes
  • Oscar Olvera Montaño
    Clinical Research, Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico
  • Leopoldo Martin Baiza-Duran
    Clinical Research, Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico
  • Patricia del Carmen Muñoz-Villegas
    Clinical Research, Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico
  • Footnotes
    Commercial Relationships   Oscar Olvera Montaño, Laboratorios Sophia, S.A. de C.V. (E); Leopoldo Baiza-Duran, Laboratorios Sophia, S.A. de C.V. (E); Patricia del Carmen Muñoz-Villegas, Laboratorios Sophia, S.A. de C.V. (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 1228. doi:
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      Oscar Olvera Montaño, Leopoldo Martin Baiza-Duran, Patricia del Carmen Muñoz-Villegas; Efficacy and tolerability of a preservative-free triple fixed combination in glaucoma patients: a prospective crossover study. Invest. Ophthalmol. Vis. Sci. 2018;59(9):1228.

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      © ARVO (1962-2015); The Authors (2016-present)

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  • Supplements
Abstract

Purpose : To evaluate efficacy and tolerability of preservative-free timolol 0.5%/brimonidine 0.02%/dorzolamide 2% (TBD) fixed combination and preservative containing TBD fixed combination (Krytantek Ofteno®) in primary open angle glaucoma (POAG) patients, previously treated and controlled with Krytantek Ofteno® for at least two months, using a prospective crossover study

Methods : Previously treated and controlled POAG patients were randomized enrolled. Group 1 ("PRO-122 to KO") patients used preservative-free TBD (PRO-122) for 30 days and then changed to preservative containing TBD (KO) for 30 days. Group 2 ("KO to PRO-122") patients used preservative containing TBD for 30 days and changed to preservative-free TBD for 30 days. At days 15, 30, 45, and 60, we measured intraocular pressure for efficacy and graded corneal erosion, Visual Function Index and subjective discomfort as safety and tolerability

Results : 102 eyes were analyzed for the efficacy outcomes (Group 1 n= 48 eyes) (Group 2 n= 54 eyes). The mean visual acuity (LogMAR) was 0.3 in both sequences, the mean deviation (MD) of the Humphrey test was -12.00±10.49 dB in group 1 and, -9.99±8.63 in group B. No differences between demographics characteristics were observed (Table 1)

Group 1 had a baseline IOP of 13.6 ± 2.95 mmHg, after 30 days of treatment with PRO-122 was 13.19 ± 3.24 mmHg, with a decrease of 0.41 mmHg, without significant difference (t(47)=1.110, p=0.272), after the crossover, the IOP was 12.60 ± 3.03 mmHg, with a decreased of 0.59 than their period with PRO-122 without significant differences (t(47)=1.79, p=0.080).
Group 2 had a baseline IOP of 12.13 ± 1.82 mmHg , after 30 days, before using PRO-122 was 11.8 ± 2.068 mmHg, 0.56 mmHg lower than their baseline without significant changes (t(53)= 1.552, p = 0.127), and after the crossover was 11.24 ± 1.565, 0.33 lower than the KO period (t(53)= 2.007, p = 0.05). (Figure 1)

Conclusions : The target IOP in patients during PRO-122 was maintained in relation to the initial target IOP of the study and when compared to Krytantek Ofteno® in group 2, had a decrease of 0.41 mmHg, which in addition to not being significant, does not represent clinical relevance and is well below the non-inferiority limit of 1.5mmHg. Finally, the treatment with PRO-122 demonstrated similar safety and tolerability to Krytantek Ofteno®.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

 

 

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