PURPOSE: To compare the ocular hypotensive efficacy and safety of a fixed-dose combination (FDC) of the Rho kinase inhibitor netarsudil and latanoprost vs monotherapy with netarsudil or latanoprost. DESIGN: Three-month primary endpoint analysis of a randomized, double-masked, phase 3 clinical trial. METHODS: Adults with open-angle glaucoma or ocular hypertension (unmedicated intraocular pressure [IOP] >20 and <36 mm Hg at 8:00 AM) were randomized to receive once-daily netarsudil/latanoprost FDC, netarsudil 0.02%, or latanoprost 0.005% for up to 12 months. The primary efficacy endpoint was mean IOP at 8:00 AM, 10:00 AM, and 4:00 PM at week 2, week 6, and month 3. RESULTS: Mean treated IOP ranged from 14.8-16.2 mm Hg for netarsudil/latanoprost FDC, 17.2-19.0 mm Hg for netarsudil, and 16.7-17.8 mm Hg for latanoprost. Netarsudil/latanoprost FDC met the criteria for superiority to each active component at all 9 time points (all P < .0001), lowering IOP by an additional 1.8-3.0 mm Hg vs netarsudil and an additional 1.3-2.5 mm Hg vs latanoprost. At month 3, the proportion of patients achieving mean diurnal IOP £15 mm Hg was 43.5% for netarsudil/ latanoprost FDC, 22.7% for netarsudil, and 24.7% for latanoprost. No treatment-related serious adverse events were reported; treatment-related systemic adverse events were minimal. The most frequent ocular adverse event was conjunctival hyperemia (netarsudil/latanoprost FDC, 53.4%; netarsudil, 41.0%; latanoprost, 14.0%), which led to treatment discontinuation in 7.1% (netarsudil/lata-noprost FDC), 4.9% (netarsudil), and 0% (latanoprost) of patients. CONCLUSIONS: Once-daily netarsudil/latanoprost FDC demonstrated IOP reductions that were statistically and clinically superior to netarsudil and latanoprost across all 9 time points through month 3, with acceptable ocular safety.
These studies demonstrated the clinical benefits of nepafenac 0.3% over vehicle in reducing the risk of postoperative ME, with the integrated analysis showing improved BCVA after cataract surgery in patients with diabetic retinopathy, with no unanticipated safety events.
Purpose To compare endothelial cell density (ECD), percentage of hexagonal cells (%Hex) and coefficient of variation (CV) in cell size following lens cataract surgery with phacoemulsification performed using Continuous Curvilinear Capsulorhexis (CCC) or Precision Pulse Capsulotomy (PPC). Patients and Methods Sixty-seven subjects were randomly assigned to undergo lens cataract removal with the capsulotomy step performed using either CCC or PPC. Specular microscopy images were obtained pre-operatively, 1 month and 3 months after surgery. ECD, %Hex and CV were analyzed in a masked fashion by an independent reading center. Results The mean percentage ECD loss at 1 month was 11.5% in the CCC group and 12.3% in the PPC group (P = 0.818; t -test). At 3 months, the mean percentage ECD loss was 11.7% in the CCC group and 12.4% in the PPC group (P = 0.815; t -test). The mean %Hex at 1 month was 54.3% in the CCC group and 54.7% in the PPC group (P = 0.695; t -test). At 3 months, the mean %Hex was 56.2% in the CCC group and 54.7% in the PPC group (P = 0.278; t -test). The CV at 1 month was 34.4% in the CCC group and 34.3% in the PPC group (P = 0.927; t -test). At 3 months, the CV was 32.7% in the CCC group and 33.4% in the PPC group (P = 0.864; t -test). Conclusion No differences in ECD loss, %Hex and CV were observed between patients who received CCC or PPC. PPC use during cataract surgery does not result in any increased endothelial cell loss beyond that normally associated with this surgery.
and the outcomes of these patients is an important consideration. If their acuity returned to premacular edema levels, then the development of PME had limited practical consequences. It would be important to know how visual acuity data were analyzed in those who developed macular edemadwas the vision after treatment of macular edema considered (i.e., "intent to treat" based on initial randomization) or was last observed vision at the time of macular edema diagnosis carried forward? If it was the latter, the results may not be representative of outcomes in clinical practice.The findings by Singh et al 1 also conflict with the results of a large retrospective real-world study, where topical NSAIDs showed no effect in patients with diabetic retinopathy undergoing cataract surgery (n ¼ 11 579). 5 This study used propensity score matching for multiple ocular and systemic factors to emulate randomized clinical trials in estimating the average treatment effect.Finally, PME is often mild, responds well to treatment, frequently resolves without intervention, and does not have significant long-term visual consequence for most patients. 5 The question remains: What is the clinical and practical usefulness of preventing a condition that is easily treatable and has limited long-term visual consequence? Knowing the long-term visual outcomes in the patients reported by Singh et al may be more helpful in determining if prophylactic NSAID use has enduring value. Future investigations should delineate which patients achieve the greatest long-term benefit to topical NSAID prophylaxis. We congratulate Singh et al 1 on their insightful and informative study.
Re: Singh et al.: Nepafenac 0.3% after cataract surgery in patients with diabetic retinopathy: results of 2 randomized phase 3 studies (Ophthalmology. 2017;124:776-785) majority of diabetic patients with less severe DR who are undergoing cataract surgery.
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