Benefits of switching from latanoprost to preservative-free tafluprost eye drops: a meta-analysis of two Phase IIIb clinical trials.

INTRODUCTION: Glaucoma patients frequently exhibit ocular surface side effects during treatment with prostaglandin eye drops. The present work investigated whether glaucoma patients suffering from signs and symptoms of ocular surface disease while using preserved latanoprost eye drops benefited from switching to preservative-free tafluprost eye drops. PATIENTS AND METHODS: The analysis was based on 339 glaucoma patients enrolled in two Phase IIIb trials. The patients were required to have two symptoms, or one sign and one symptom of ocular surface disease at baseline, and at least 6 months preceding treatment with latanoprost eye drops preserved with benzalkonium chloride. All eligible patients were switched from latanoprost to preservative-free tafluprost for a total of 12 weeks. Ocular symptoms and ocular signs were evaluated at baseline and at 2 weeks, 6 weeks, and 12 weeks after commencing treatment with tafluprost. Intraocular pressure (IOP), drop discomfort, and treatment preference were evaluated to investigate the clinical efficacy and patient-related outcomes. RESULTS: After 12 weeks of treatment with preservative-free tafluprost, the incidences of irritation/burning/stinging, foreign body sensation, tearing, itching, and dry eye sensation had diminished to one-third of those reported for preserved latanoprost at baseline. The incidences of blepharitis and corneal/conjunctival fluorescein staining had in turn decreased to one-half of those reported for preserved latanoprost. Severity of conjunctival hyperemia was halved during treatment with preservative-free tafluprost, and there was significant improvement in tear break-up time and tear production. A further reduction in IOP (~1 mmHg) was seen with preservative-free tafluprost compared with preserved latanoprost. Drop discomfort was alleviated during preservative-free tafluprost treatment, and an outstanding majority of patients (72%) preferred preservative-free tafluprost over preserved latanoprost. CONCLUSION: This meta-analysis confirmed that IOP remained at the same level after replacing benzalkonium chloride-preserved latanoprost eye drops with preservative-free tafluprost eye drops. Preservative-free tafluprost significantly decreased the symptoms and signs of ocular surface disease and outrated latanoprost in drop comfort and treatment preference.

Assessment of dry eye signs and symptoms and ocular tolerance of a preservative-free lacrimal substitute (Hylabak®) versus a preserved lacrimal substitute (Systane®) used for 3 months in patients after LASIK.

Laser-assisted in situ keratomileusis (LASIK) is commonly used to correct refractive defects. The procedure frequently results in dry eye symptoms, usually of short but sometimes longer duration. This study was designed to assess dry eye and ocular tolerability after LASIK in patients treated with a preservative-free lacrimal substitute (Hylabak®) or preserved lacrimal substitute (Systane®). In a single-center, investigator-masked, prospective, noninferiority, clinical study, patients undergoing LASIK surgery were randomized to receive Hylabak or Systane eye drops (one drop in each eye four times daily for 3 months). Fluorescein test scores were the primary efficacy variable and were similar on day 1 (mean 0.26 and 0.28 for Hylabak and Systane, respectively). At the final visit (day 84 ± 3) the fluorescein scores had improved to 0.11 and 0.04, respectively. The difference was not significant and thus noninferiority was established. A trend of more rapid improvement in the Hylabak group was evident. Both treatments were well tolerated and there were no serious adverse events, discontinuations for adverse events or other safety-related reasons, and no systemic adverse events. The results suggest that Hylabak is not less effective than Systane in reducing the symptoms of dry eye after LASIK surgery.

Risk factors associated with progression in exfoliative glaucoma patients.

PURPOSE: To evaluate exfoliative glaucoma (XFG) patients over 5 years, determining risk factors associated with progression or non-progression of glaucoma. METHODS: A retrospective, observational study. Patients were chosen from consecutive charts and data collected from each available visit included in the follow-up period. Data were abstracted for non-progressed XFG patients for 5 years and for progressed patients until glaucoma worsened. Progression was determined from patient records and by disc photographs. RESULTS: There were 71 (53%) progressed and 63 (47%) non-progressed XFG patients.Baseline parameters demonstrated worse visual field damage (p=0.014) and more prescribed medicines (p=0.03) in progressed patients. The mean intraocular pressure (IOP) for progressed patients was 18.7±4.3 and 17.3±3.4 mm Hg for non-progressed patients (p=0.047). The mean IOP that best separated the groups was 17 mm Hg with 60% staying non-progressed at or below this level and 30% above this level. At the last visit, progressed patients had more medicines prescribed (1.7) than non-progressed patients (1.3, p=0.005). A multivariate regression analysis showed higher mean, peak and variance of IOP, number of glaucoma medications at the final visit and presence of a disc hemorrhage (n=5) as independent risk factors for progression (p≤0.05). CONCLUSION: IOP reduction in XFG may be essential in reducing disease progression. The presence of disc hemorrhage in XFG may suggest an increased probability of progression despite treatment to within the normal IOP range.

Is there any difference in target intraocular pressure for exfoliative glaucoma patients with cardiovascular disease history?

PURPOSE: To investigate if patients with exfoliation glaucoma (XFG) with cardiovascular disease (CVD) require different target intraocular pressure (IOP) compared to patients with XFG with no CVD for long-term stability. METHODS: A retrospective, multicenter, observational cohort analysis included consecutive patients with XFG from 9 European academic centers, with a minimum of 5 years follow-up. RESULTS: In 201 patients, there was a statistical difference between progressed and non-progressed patients in mean (p=0.0049) and peak (p=0.015) IOP, variance of IOP (p=0.028), and number of medicine changes/year (p=0.0037). At a mean IOP ≥22 mmHg, patients progressed in 84% (32/38), between 14 and 21 mmHg in 54% (81/151), and at ≤13 mmHg in 33% (4/12). There was no difference in the rate of progression between groups based on CVD history (p=0.65). However, IOP that allowed ≤50% progression rate for patients with mild or no CVD was ≤20-21 mmHg and ≤18 mmHg for patients with severe disease. Further, at IOP ≥20 mmHg, 8% (1/12) of patients with severe CVD remained stable in contrast to 38% (16/42) of patients with mild and 21% (4/19) with no CVD history (p=0.0093). By multivariant regression analysis of the IOP and CVD measures, mean IOP was a risk factor for progression (p=0.0097). CONCLUSIONS: Although IOP is the main determinant of progression in XFG under treatment, history of severe CVD should be further investigated as potential risk factor for glaucomatous progression.

Factors associated with long-term progression or stability in exfoliation glaucoma.

OBJECTIVE: To evaluate the effect of intraocular pressure (IOP) reduction on long-term progression or stability in patients with exfoliation glaucoma. DESIGN: Multicenter (Greece, Spain, Russia, and Hungary), retrospective analysis. METHODS: Medical record analysis of 167 patients with at least 5 years of follow-up, who were stable (n = 85) or whose condition had progressed (n = 82) after the beginning of the follow-up period. RESULTS: The mean +/- SD IOP was 18.1 +/- 2.6 mm Hg in the stable group and 20.1 +/- 4.3 mm Hg in the progressed group (P<.001). The mean +/- SD follow-up time was 6.1 +/- 2.3 years for the stable group and 3.4 +/- 1.7 years for the progressed group. The mean SD for each patient's average IOP was 2.9 mm Hg for the stable group and 4.6 mm Hg for the progressed group (P<.001). Twenty-eight percent of patients who had a mean IOP of 17 mm Hg or lower, 43% of those with an IOP of 18 to 19 mm Hg, and 70% of those with an IOP of 20 mm Hg or higher progressed. Progressed patients had statistically greater optic disc damage at baseline and more medication changes and trabeculectomies during follow-up than stable patients (P<.05). CONCLUSION: This study suggests that IOP reduction helps to prevent glaucoma progression in patients with exfoliation glaucoma, although it does not guarantee the prevention or worsening of the disease.