A Study of the Safety and Efficacy of Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution Compared to Latanoprost 0.005% and Timolol 0.5% Dosed Concomitantly in Patients with Open-Angle Glaucoma or Ocular Hypertension

Background/Aims: To compare the intraocular pressure (IOP)-lowering efficacy of travoprost 0.004%/timolol 0.5% in fixed combination with the unfixed combination of latanoprost 0.005% and timolol 0.5% in open-angle glaucoma or ocular hypertension patients with IOP levels below 18 mmHg on the unfixed combination of latanoprost 0.005% and timolol 0.5%. Methods: Following a 30-day open-label run-in with latanoprost QD PM and timolol QD AM, subjects with intraocular pressure below 18 mmHg were randomized to continue concomitant latanoprost QD PM and timolol QD AM or switch to travoprost 0.004%/timolol 0.5% QD AM and vehicle QD PM in masked fashion and were followed for 3 months. The primary efficacy endpoint was mean IOP reduction from baseline. Results: There were no clinically relevant or statistically significant differences in mean IOP, mean IOP change from baseline, or percentage IOP change from baseline between the two treatment groups. Between-group differences in mean IOP were within ±0.3 mmHg at all time points (p ≥ 0.384), and between-group differences in mean IOP change from baseline were within ±0.4 mmHg at all time points. Overall, 88% of patients whose IOP was less than 18 mmHg on the unfixed combination of latanoprost and timolol remained well controlled on the same regimen in the masked portion of the study, compared with 92% who remained well controlled after switching to travoprost/timolol. Conclusion: Travoprost 0.004%/timolol 0.5% administered once daily and concomitant administration of timolol 0.5% and latanoprost 0.005% produce similar maintenance of IOP-lowering effect in patients who were previously well controlled on concomitant administration of latanoprost and timolol. Patients who are well controlled on latanoprost and timolol concomitant therapy can be switched to once-daily therapy with travoprost 0.004%/timolol 0.5% with no expected compromise in the safety and efficacy of their treatment

Natural locomotion based on a reduced set of inertial sensors: decoupling body and head directions indoors

Inertial sensors offer the potential for integration into wireless virtual reality systems that allow the users to walk freely through virtual environments. However, owing to drift errors, inertial sensors cannot accurately estimate head and body orientations in the long run, and when walking indoors, this error cannot be corrected by magnetometers, due to the magnetic field distortion created by ferromagnetic materials present in buildings. This paper proposes a technique, called EHBD (Equalization of Head and Body Directions), to address this problem using two head- and shoulder-located magnetometers. Due to their proximity, their distortions are assumed to be similar and the magnetometer measurements are used to detect when the user is looking straight forward. Then, the system corrects the discrepancies between the estimated directions of the head and the shoulder, which are provided by gyroscopes and consequently are affected by drift errors. An experiment is conducted to evaluate the performance of this technique in two tasks (navigation and navigation plus exploration) and using two different locomotion techniques: (1) gaze-directed mode (GD) in which the walking direction is forced to be the same as the head direction, and (2) decoupled direction mode (DD) in which the walking direction can be different from the viewing direction. The obtained results show that both locomotion modes show similar matching of the target path during the navigation task, while DD’s path matches the target path more closely than GD in the navigation plus exploration task. These results validate the EHBD technique especially when allowing different walking and viewing directions in the navigation plus exploration tasks, as expected. While the proposed method does not reach the accuracy of optical tracking (ideal case), it is an acceptable and satisfactory solution for users and is much more compact, portable and economical

A study of the safety and efficacy of travoprost 0.004%/timolol 0.5% ophthalmic solution compared to latanoprost 0.005% and timolol 0.5% dosed concomitantly in patients with open-angle glaucoma or ocular hypertension

Douglas J Rhee1, James H Peace2, Sushanta Mallick3, Theresa A Landry3, Michael VW Bergamini3, and the Study Group*1Massachusetts Eye and Ear Infirmary, Harvard University, Boston, MA, USA; 2Diabetic Eye Medical Clinic, Inglewood, CA, USA; 3Alcon Laboratories, Inc., Ft. Worth, TX, USA; *Study Group members listed in AppendixBackground/Aims: To compare the intraocular pressure (IOP)-lowering efficacy of travoprost 0.004%/timolol 0.5% in fixed combination with the unfixed combination of latanoprost 0.005% and timolol 0.5% in open-angle glaucoma or ocular hypertension patients with IOP levels below 18 mmHg on the unfixed combination of latanoprost 0.005% and timolol 0.5%.Methods: Following a 30-day open-label run-in with latanoprost QD PM and timolol QD AM, subjects with intraocular pressure below 18 mmHg were randomized to continue concomitant latanoprost QD PM and timolol QD AM or switch to travoprost 0.004%/timolol 0.5% QD AM and vehicle QD PM in masked fashion and were followed for 3 months. The primary efficacy endpoint was mean IOP reduction from baseline.Results: There were no clinically relevant or statistically significant differences in mean IOP, mean IOP change from baseline, or percentage IOP change from baseline between the two treatment groups. Between-group differences in mean IOP were within ±0.3 mmHg at all time points (p ≥ 0.384), and between-group differences in mean IOP change from baseline were within ±0.4 mmHg at all time points. Overall, 88% of patients whose IOP was less than 18 mmHg on the unfixed combination of latanoprost and timolol remained well controlled on the same regimen in the masked portion of the study, compared with 92% who remained well controlled after switching to travoprost/timolol.Conclusion: Travoprost 0.004%/timolol 0.5% administered once daily and concomitant administration of timolol 0.5% and latanoprost 0.005% produce similar maintenance of IOP-lowering effect in patients who were previously well controlled on concomitant administration of latanoprost and timolol. Patients who are well controlled on latanoprost and timolol concomitant therapy can be switched to once-daily therapy with travoprost 0.004%/timolol 0.5% with no expected compromise in the safety and efficacy of their treatment.Keywords: travoprost, timolol, glaucoma, intraocular pressure, fixed combinatio

An improved synthesis, crystal structures, and metallochromism of salts of [Ru(tolyl-terpy)(CN)(3)](-)

The previously reported complex [Ru(ttpy)(CN)(3)] [ttpy = 4'(p-tolyl)-2,2':6',2"-terpyridine] is conveniently synthesised by reaction of ttpy with Ru(dmso)(4)Cl-2 to give [Ru(ttpy)(dmso)Cl-2], which reacts in turn with KCN in aqueous ethanol to afford [Ru(ttpy)(CN)(3)] which was isolated and crystallographically characterised as both its (PPN)(+) and K+ salts. The K+ salt contains clusters containing three complex anions and three K+ cations connected by end-on and side-on cyanide ligation to the K+ ions. The solution speciation behaviour of [Ru(ttpy)(CN)(3)] was investigated with both Zn2+ and K+ salts in MeCN, a solvent sufficiently non-competitive to allow the added metal cations to associate with the complex anion via the externally-directed cyanide lone pairs. UV-Vis spectroscopic titration of (PPN)[Ru(ttpy)(CN)(3)] with Zn(ClO4)(2) showed a blue shift of 2900 cm (1) in the (MLCT)-M-1 absorption manifold due to the ` metallochromism' effect; a series of distinct binding events could be discerned corresponding to formation of 4:1, 1:1 and then 1:3 anion: cation adducts, all with high formation constants, as the titration proceeded. In contrast titration of (PPN)[Ru(ttpy)(CN)(3)] with the more weakly Lewis-acidic KPF6 resulted in a much smaller blue-shift of the 1MLCT absorptions, and the titration data corresponded to formation of 1:1 and then 2: 1 cation: anion adducts with weaker stepwise association constants of the order of 10(4) and then 10(3) M (1). Although association of [Ru(ttpy)(CN)(3)] resulted in a blue-shift of the (MLCT)-M-1 absorptions, the luminescence was steadily quenched, as raising the (MLCT)-M-3 level makes radiationless decay via a lowlying (MC)-M-3 state possible. (C) 2010 Elsevier B. V. All rights reserved

Treatment of steroid-induced elevated intraocular pressure with anecortave acetate: a randomized clinical trial.

PURPOSE: The present study is the first randomized clinical trial designed to evaluate the intraocular pressure (IOP)-lowering effect of anecortave acetate (AA) administered at 3 doses (3, 15, or 30 mg) as an anterior juxtascleral depot (AJD) in patients experiencing elevated IOP due to corticosteroid therapy. METHODS: This was a double-masked, randomized, placebo-controlled, multicenter, parallel group trial. Eligible patients had an IOP of at least 24 mmHg and an IOP increase of at least 10 mmHg relative to their IOP before treatment with steroids. A target IOP was established for each patient at baseline. Patients were randomized to 1 of the 4 treatment groups: vehicle, 3 mg AA, 15 mg AA, or 30 mg AA. All patients then received a 0.5 mL AJD of the assigned treatment. Patients returned for scheduled examination visits at weeks 1, 2, 4, 6, months 3, 4, 5, and 6. IOP was measured at each visit as well as best corrected visual acuity (logMAR), ocular motility, eyelid responsiveness, slit lamp examination, and assessment of any adverse events. In addition, at baseline and at exit, a dilated fundus examination was carried out and the lens was examined using LOCS II criteria. RESULTS: Seventy patients were randomized to treatment. At week 4, eyes in the vehicle group showed a 3.4 mmHg (9.1%) decrease from baseline. Reductions for the 3 mg AA (3.1 mmHg, 10.7%) and the 30 mg AA groups (5.4 mmHg, 16.6%) were not significantly different than for vehicle control. However, IOP for the 15 mg AA group at week 4 was reduced 11.5 mmHg (31.3%) from baseline, which was statistically significant (P=0.0487). The mean time to treatment failure was 32.2, 38.9, 56.3, and 32.6 days for the vehicle, 3 mg AA, 15 mg AA, and 30 mg AA groups, respectively. Adverse events were assessed at each post-treatment visit. There were no serious adverse events that were determined to be related to the test article or its administration. CONCLUSIONS: AA can be of benefit to some patients requiring treatment with corticosteroids, but suffering from the side effect of elevated IOP