July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
Efficacy and tolerability of a preservative-free 0.005% latanoprost in glaucoma patients: a prospective crossover study
Author Affiliations & Notes
  • Leopoldo Martin Baiza-Duran
    Clinical Research, Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico
  • Oscar Olvera Montaño
    Clinical Research, Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico
  • Footnotes
    Commercial Relationships   Leopoldo Baiza-Duran, Laboratorios Sophia, S.A. de C.V. (E); Oscar Olvera Montaño, Laboratorios Sophia, S.A. de C.V. (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 1243. doi:
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      Leopoldo Martin Baiza-Duran, Oscar Olvera Montaño; Efficacy and tolerability of a preservative-free 0.005% latanoprost in glaucoma patients: a prospective crossover study. Invest. Ophthalmol. Vis. Sci. 2018;59(9):1243.

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

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Abstract

Purpose : To evaluate efficacy and tolerability of preservative-free 0.005% latanoprost (PRO067) and preservative containing 0.005% latanoprost (GAAP Ofteno®) in primary open angle glaucoma (POAG) patients, previously treated and controlled with GAAP Ofteno® for at least two months, using a prospective crossover study

Methods : Previously treated and controlled POAG patients were randomized enrolled. Group 1 ("PRO067 to GO") patients used PRO067 for 30 days and then changed to GAAP Ofteno® for 30 days. Group 2 ("GO to PRO067") patients used GAAP Ofteno® for 30 days and changed to PRO067 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 : 99 patients were analyzed for the efficacy outcomes (Group 1 n= 49) (Group 2 n= 50). Mean visual acuity was 20/20 in group 1, and 20/30 in group 2, the mean deviation of the perimetry was -5.12±5.65 dB in group 1 and, -3.73±3.97 in group 2. No differences between demographics characteristics were observed (Table 1)
On group 1, the baseline IOP was 14.25±2.37 before the crossover was 13.85 ± 2.07 mmHg, with a decrease of 0.41 mmHg, without significant difference (t(48)=-1.731, p=0.090), final IOP was 13.99 ± 2.46 mmHg, with an increase of 0.14 mmHg without significant differences (t(48)=0.718, p=0.476).
The mean baseline IOP on group 2 was 14.04 ± 2.43 mmHg, before crossover was 13.92 ± 2.18 mmHg, 0.12 mmHg lower without significant changes (t(49)= -0.569, p = 0.572), and final IOP was 14.07 ± 2.37, with an increase of 0.15 mmHg (t(49)= 0.614, p = 0.542), at the end of the study.
The control on target IOP was maintained during the two months of the clinical protocol regardless the period of the study (F(4,192)=1.442, p=0.222), the efficacy in control the target IOP did not show statistical differences between groups (F(1,48)=0.1675, p=0.898). Table 2

Conclusions : The target IOP in patients during PRO-067 was maintained in relation to the initial target IOP of the study and when compared to GAAP Ofteno® in group B, had an increase of 0.15 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-067 demonstrated similar safety and tolerability to GAAP 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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