A randomized, crossover, open label pilot study to evaluate the efficacy and safety of Xalatan ® in comparison with generic Latanoprost (Latoprost) in subjects with primary open angle glaucoma or ocular hypertension

<b>Aim: </b> To compare the efficacy and tolerability of Xalatan &#x00AE; with generic latanoprost (Latoprost) in subjects with primary open angle glaucoma (POAG) or ocular hypertension (OH). <b> Materials and Methods:</b> This was a single-center, randomized, open labe...

Full description

Bibliographic Details
Main Authors: Narayanaswamy Arun, Neog Aditya, Baskaran M, George Ronnie, Lingam Vijaya, Desai Chetan, Rajadhyaksha Viraj
Format: Article
Language:English
Published: Wolters Kluwer Medknow Publications 2007-01-01
Series:Indian Journal of Ophthalmology
Subjects:
Online Access:http://www.ijo.in/article.asp?issn=0301-4738;year=2007;volume=55;issue=2;spage=127;epage=131;aulast=Narayanaswamy
Description
Summary:<b>Aim: </b> To compare the efficacy and tolerability of Xalatan &#x00AE; with generic latanoprost (Latoprost) in subjects with primary open angle glaucoma (POAG) or ocular hypertension (OH). <b> Materials and Methods:</b> This was a single-center, randomized, open label, crossover, two period comparative study. At the baseline visit, subjects were randomized to two groups. Group A received Xalatan &#x00AE; for weeks 1-12 followed by Latoprost for weeks 13-24. Group B received Latoprost for weeks 1-12 followed by Xalatan &#x00AE; for weeks 13-24. <b> Results:</b> 30 subjects were recruited, 12 in Group A and 18 in Group B. In subjects administered Xalatan &#x00AE;, intraocular pressure (IOP) showed a greater decrease (<i> P</i> &#60; 0.001) from 23.64 &#x00B1; 3.13 mmHg at baseline to 14.29 &#x00B1; 1.61 mmHg at week 12 (fall of 9.35 &#x00B1; 3.55 mmHg, 38.66&#x0025; &#x00B1; 10.29) than that seen in the Latoprost group (22.74 &#x00B1; 2.47 mmHg to 16.98 &#x00B1; 2.49 mmHg, fall of 5.76 &#x00B1; 1.41 mmHg; 25.42&#x0025; &#x00B1; 5.98). In period 2 when subjects were crossed over to Xalatan &#x00AE; from Latoprost, there was a further fall from 16.98 &#x00B1; 2.49 mmHg to 16.09 &#x00B1; 1.49 at week 24 (fall of 0.89 &#x00B1; 1.59 mmHg; 4.3&#x0025; &#x00B1; 8.76). However, when subjects were crossed over to Latoprost from Xalatan &#x00AE;, the IOP rose from 14.29 &#x00B1; 1.61 mmHg to 15.36 &#x00B1; 1.71 mmHg at week 24 (8.86&#x0025; &#x00B1; 17.76). There was no significant difference in incidence of conjunctival hyperemia or any other adverse events in both the groups. <b> Conclusion:</b> The magnitude of IOP lowering in patients with POAG and OH with Xalatan &#x00AE; and Latoprost is different. In our study, the IOP lowering with Xalatan &#x00AE; was higher than that with Latoprost.
ISSN:0301-4738