Five-year, Multicenter Safety Study of Fixed-combination Latanoprost/Timolol (Xalacom) for Open-angle Glaucoma and Ocular Hypertension

Alm, Albert; Grunden, John W.; Kwok, Kenneth

doi:10.1097/ijg.0b013e3181e08121

Cited by 17 publications

(12 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Combination glaucoma drugs enable the possibility of synergistic medical therapies for greater IOP-lowering effect 12–15. Although these drugs may offer IOP reduction with increased compliance over instillation of multiple types of medications, there are still disadvantages, including high cost, inconvenience, potential side effects such as corneal epithelial cell damage, and noncompliance.…”

Section: Introductionmentioning

confidence: 99%

Prospective unmasked randomized evaluation of the iStent inject® versus two ocular hypotensive agents in patients with primary open-angle glaucoma

Fea

Belda

Rękas

et al. 2014

OPTH

View full text Add to dashboard Cite

PurposeThe purpose of this study was to compare outcomes of subjects with open-angle glaucoma (OAG) not controlled on one medication who underwent either implantation of two iStent inject® trabecular micro-bypass devices or received medical therapy consisting of a fixed combination of latanoprost/timolol.Patients and methodsOf 192 subjects who qualified for the study and were enrolled, 94 were randomized to surgery with implantation of two iStent inject® devices in the treated eye and 98 to receive medical therapy.ResultsAt the month 12 visit, 94.7% of eyes (89/94) in the stent group reported an unmedicated intraocular pressure (IOP) reduction of ≥20% versus baseline unmedicated IOP, and 91.8% of eyes (88/98) in the medical therapy group reported an IOP reduction ≥20% versus baseline unmedicated IOP. A 17.5% between-group treatment difference in favor of the iStent inject group was statistically significant (P=0.02) at the ≥50% level of IOP reduction. An IOP ≤18 mmHg was reported in 92.6% of eyes (87/94) in the iStent inject group and 89.8% of eyes (88/98) in the medical therapy group. Mean (standard deviation) IOP decreases from screening of 8.1 (2.6) mmHg and 7.3 (2.2) mmHg were reported in the iStent inject and medical therapy groups, respectively. A high safety profile was also noted in this study in both the iStent inject and medical therapy groups, as measured by stable best corrected visual acuity, cup-to-disc ratio, and adverse events.ConclusionThese data show that the use of iStent inject is at least as effective as two medications, with the clinical benefit of reducing medication burden and assuring continuous treatment with full compliance to implant therapy as well as having a highly favorable safety profile.

show abstract

Section: Introductionmentioning

confidence: 99%

Prospective unmasked randomized evaluation of the iStent inject® versus two ocular hypotensive agents in patients with primary open-angle glaucoma

Fea

Belda

Rękas

et al. 2014

OPTH

View full text Add to dashboard Cite

show abstract

“…Early-phase CTs (phases I/II and III) showed a significant increase over time in the use of biomarkers for patient selection and stratification (including predictive, diagnostic Although 30 of 59 (50.8%) of phase III CTs used secondary surrogate imaging endpoints, we found only 3 of 59 (5.1%) phase III CTs including primary surrogate imaging endpoints: two on retina 16,17 (macular thickness by optical coherence tomography [OCT] and lesion enlargement by fundus autofluorescence) and one on glaucoma 18 (iris color photography). Conversely, phase IV CTs included primary surrogate imaging endpoints in 75 of 275 (27.2%) cases; P < 0.001.…”

Section: Thementioning

confidence: 65%

Decade-Long Profile of Imaging Biomarker Use in Ophthalmic Clinical Trials

Massaro

Scaramuzzi

Hamrah

et al. 2017

Invest. Ophthalmol. Vis. Sci.

View full text Add to dashboard Cite

PURPOSE. The purpose of this study was to investigate the use of imaging biomarkers in published clinical trials (CTs) in ophthalmology and its eventual changes during the past 10 years. METHODS.We sampled from published CTs in the fields of cornea, retina, and glaucoma between 2005-2006 and 2015-2016. Data collected included year of publication, phase, subspecialty, location, compliance with Consolidated Standards for Reporting Trials, impact factor, presence and use of imaging biomarkers (diagnostic, prognostic and predictive; primary and secondary surrogate endpoints), and use of centralized reading centers.RESULTS. We included 652 articles for analysis, equally distributed in three timeframes (2005-2006, 2010-2011, and 2015-2016), mainly reporting phase IV CTs and trials on procedures (42.2% and 35.4%, respectively). Imaging biomarkers were included in 46.3% of the analyzed CTs and their use significantly increased over time (P < 0.05). Optical coherence tomography was the most frequently used device (27.7%), whereas diagnostic biomarkers and secondary surrogate endpoints were the most frequent biomarker types (19.5% and 22.5%, respectively). Early-phase CTs showed an increase in the use of biomarkers for patient selection and stratification over time (P < 0.05), but not in the use of imaging surrogate endpoints (P ¼ 0.90). Only 3 of 59 (5.1%) of phase III CTs included primary surrogate imaging endpoints, whereas secondary surrogate imaging endpoints were present in 50.8% of these trials (P < 0.001). Retinal CTs had the highest prevalence for each type of imaging biomarker (P < 0.001). Reading centers were used in 52 of 302 CTs (17.2%), with no significant time-related increase.CONCLUSIONS. Imaging biomarkers are increasingly used in published CTs in ophthalmology. Additional efforts, including centralized reading centers, are needed to improve their validation and use, allowing a wider use of these tools as primary surrogate endpoints in phase III CTs.

show abstract

“…The prevalence of eyelid pigmentation was reported to be between 0 and 61.5% [5, 11, 13, 18, 26]. The racial difference and the duration of PGA administration may explain the differences in the results.…”

Section: Discussionmentioning

confidence: 99%

“…Custer et al [13] retrospectively reviewed PAP in 35 patients using PGAs, and they reported that eyelid pigmentation was not grossly recognized in their case series. In a Swedish study analyzing the safety of a latanoprost/timolol fixed combination, eyelid pigmentation was reported in 6.2% of patients at 60 months of administration [26]. However, Yoshino et al [11] reported that eyelid pigmentation was noticed in 61.5% of Japanese patients who used PGAs for a mean of 67.7 months.…”

Section: Discussionmentioning

confidence: 99%

Periorbital changes associated with prostaglandin analogs in Korean patients

et al. 2017

View full text Add to dashboard Cite

BackgroundProstaglandin analogs (PGAs) are commonly used to treat glaucoma because of their powerful intraocular pressure lowering effect. However, various periorbital changes associated with the use of PGAs have been reported. We investigated the incidence of periorbital changes in Korean patients who were treated with PGAs, and analyzed clinical factors associated with superior sulcus deepening.MethodsThis study included 58 glaucoma patients who were treated with latanoprost, travoprost, or bimatoprost unilaterally. Face photographs were collected, and periorbital changes such as superior sulcus deepening, eyelid pigmentation, ptosis, lid retraction, dermatochalasis, and redness were evaluated by two oculoplastic specialists. For each patient, the contralateral eye served as a control. The frequency of ptosis, dermatochalasis, pigmentation, erythema, and superior sulcus deepening were analyzed. Demographic and ocular factors were compared between patients who showed superior sulcus deepening and those who did not.ResultsThirty-one patients (53.4%) showed one or more periorbital changes associated with PGAs. The most common change was superior sulcus deepening (24.1%), followed by eyelid pigmentation (19.0%), eyelid erythema (19.0%), dermatochalasis (10.3%), eyelid retraction (5.2%), and ptosis (3.4%). The age of the patient and the duration of PGA administration was significantly correlated with superior sulcus deepening (p = 0.007, p = 0.002, respectively).ConclusionsPeriorbital changes are frequently seen in patients who use PGAs, and superior sulcus deepening is the most common change in Korean patients. Long-term use of PGAs and old age were associated with superior sulcus deepening.

show abstract

Five-year, Multicenter Safety Study of Fixed-combination Latanoprost/Timolol (Xalacom) for Open-angle Glaucoma and Ocular Hypertension

Abstract: After 5 years, more than 70% of participants treated with fixed-combination latanoprost/timolol had no increased iris pigmentation. The fixed combination is safe and well tolerated for long-term treatment in patients with open-angle glaucoma or ocular hypertension.

Cited by 17 publications

References 23 publications

Prospective unmasked randomized evaluation of the iStent inject® versus two ocular hypotensive agents in patients with primary open-angle glaucoma

Prospective unmasked randomized evaluation of the iStent inject® versus two ocular hypotensive agents in patients with primary open-angle glaucoma

Decade-Long Profile of Imaging Biomarker Use in Ophthalmic Clinical Trials

Periorbital changes associated with prostaglandin analogs in Korean patients

Contact Info

Product

Resources

About

Five-year, Multicenter Safety Study of Fixed-combination Latanoprost/Timolol (Xalacom) for Open-angle Glaucoma and Ocular Hypertension

Abstract: After 5 years, more than 70% of participants treated with fixed-combination latanoprost/timolol had no increased iris pigmentation. The fixed combination is safe and well tolerated for long-term treatment in patients with open-angle glaucoma or ocular hypertension.

Cited by 17 publications

References 23 publications

Prospective unmasked randomized evaluation of the iStent inject&reg; versus two ocular hypotensive agents in patients with primary open-angle glaucoma

Prospective unmasked randomized evaluation of the iStent inject&reg; versus two ocular hypotensive agents in patients with primary open-angle glaucoma

Decade-Long Profile of Imaging Biomarker Use in Ophthalmic Clinical Trials

Periorbital changes associated with prostaglandin analogs in Korean patients

Contact Info

Product

Resources

About

Prospective unmasked randomized evaluation of the iStent inject® versus two ocular hypotensive agents in patients with primary open-angle glaucoma

Prospective unmasked randomized evaluation of the iStent inject® versus two ocular hypotensive agents in patients with primary open-angle glaucoma