Inter-visit Intraocular Pressure Range: An Alternative Parameter for Assessing Intraocular Pressure Control in Clinical Trials - 21/08/11
, Lie-Ju Hwang b, John W. Grunden b, Gerald W. Bean c
Inquiries to Rohit Varma, Doheny Eye Institute and the Department of Ophthalmology, Keck School of Medicine, University of Southern California, 1450 San Pablo Street, DEI – 4900, Los Angeles, CA 90033Résumé |
Purpose |
To evaluate whether inter-visit intraocular pressure (IOP) range, which reflects extreme and potentially damaging IOP fluctuations, provides additional information on IOP control compared to mean IOP.
Design |
Post hoc analysis of Xalatan/Lumigan/Travatan study data, a masked-evaluator, randomized, parallel-group comparison of 12-week efficacy of latanoprost, bimatoprost, and travoprost in open-angle glaucoma/ocular hypertension patients.
Methods |
Pretreatment inter-visit IOP range defined as highest IOP minus lowest IOP at screening, safety check, and baseline (six measurements); posttreatment inter-visit IOP range defined as highest IOP minus lowest IOP at weeks two, six, and 12 or early termination (nine measurements). Ranges dichotomized as “high” (>6 mm Hg) vs “low” (≤6 mm Hg).
Results |
Included were 410 patients (latanoprost, 136; bimatoprost, 136; travoprost, 138). Each resulted in significant mean IOP range reductions during 12 weeks. Pretreatment inter-visit IOP range was associated with African-American race, male gender, and presence of visual field defect (P < .05 for all). Percentages with high pretreatment inter-visit IOP ranges were comparable across treatments (63% to 64%). High posttreatment inter-visit IOP range was seen in 21% (28/136), 28% (38/136), and 36% (50/138) of latanoprost, bimatoprost, and travoprost groups, respectively (P = .016, overall; P = .005, latanoprost vs travoprost). High posttreatment inter-visit IOP range was associated with African-American race, high pretreatment inter-visit IOP range, and treatment with travoprost vs latanoprost (P < .05 for all).
Conclusions |
Given that high inter-visit IOP range is associated with risk factors for glaucomatous damage and that such differences cannot be evaluated using mean IOPs, inter-visit IOP range may be another useful approach to assessing IOP control in clinical trials.
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Vol 145 - N° 2
P. 336-342 - février 2008 Retour au numéro
Article précédent
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