Aim:To compare the conjunctival and corneal reactions of commercially available solution of latanoprost (Xalatan) and preservative-free (PF) tafluprost in rabbits.Methods:The rabbits received 50 μl of phosphate-buffered saline (PBS), PF-tafluprost 0.0015%, latanoprost 0.005% or benzalkonium chloride (BAK) 0.02%; all solutions were applied at 5 min intervals for a total of 15 times. The ocular surface toxicity was investigated using slit-lamp biomicroscopy examination, flow cytometry (FCM) and on imprints for CD45 and tumour necrosis factor-receptor 1 (TNFR1) conjunctival impression cytology (CIC) and corneal in vivo confocal microscopy (IVCM). Standard immunohistology also assessed inflammatory/apoptotic cells.Results:Clinical observation and IVCM images showed the highest ocular surface toxicity with latanoprost and BAK, while PF-tafluprost and PBS eyes presented almost normal corneoconjunctival aspects. FCM showed a higher expression of CD45+ and TNFR1+ in latanoprost- or BAK-instilled groups, compared with PF-tafluprost and PBS groups. Latanoprost induced fewer positive cells for inflammatory marker expressions in CIC specimens compared with BAK-alone, both of which were higher than with PF-tafluprost or PBS. Immunohistology showed the same tendency of toxic ranking.Conclusion:The authors confirm that rabbit corneoconjunctival surfaces presented a better tolerance when treated with PF-tafluprost compared with commercially available latanoprost or BAK solution.
Purpose To evaluate the efficacy and safety of the Ultrasonic Circular Cyclo Coagulation (UC3) procedure in patients with primary open‐angle glaucoma (POAG).
Methods Prospective multicenter clinical trial. 39 eyes of 39 patients with POAG, intraocular pressure (IOP) > 21 mmHg, an average of 1.65 failed previous surgeries and an average of 3.2 hypotensive medications were insonified with a probe comprising 6 piezoelectric transducers. 18 patients (group 1) were treated with a 4 seconds exposure time for each shot and 21 patients (group 2) with a 6 seconds exposure time. Follow‐up visits were performed at 1 day, 1 week, 1, 2, 3, 6 and 12 months after.
Results IOP was significantly reduced in both groups (p<0.05), from a mean preoperative value of 28.9 ± 6.8 mmHg in group 1 and 29.2 ± 6.9 mmHg in group 2 to a mean value of 18.1 ± 4.4 mmHg in group 1 and 16.1 ± 8,5 mmHg in group 2 at last follow‐up. Success (IOP reduction >20%) was achieved in 15 of 18 (83%) eyes of the group 1 with an average of IOP decrease of 42% and in 19 of 21 (90%) eyes of the group 2 with an average of IOP decrease of 49%. No major intra‐ or post‐operative complications occurred.
Conclusion UC3 seems to be an effective and well‐tolerated method to reduce intraocular pressure in patients with POAG.
Commercial interest
Purpose The relationship between ocular surface inflammation, signs and symptoms in DED remains poorly understood. A correlation between ocular surface inflammation and CFS in DED patients is reported.
Methods DED patients with tear break up time ≤8 seconds and CFS grades 2‐4 modified Oxford scale and Schirmer test without anesthesia ≥2 and <10 mm/5min and lissamine green staining, Van Bijsterveld >4 and at least 1 dry eye symptom were randomized to CYCLOKAT® (unpreserved 0.1% cyclosporine cationic emulsion) or vehicle QD. Impression cytology for conjunctival HLA‐DR expression (an ocular surface inflammatory biomarker) was performed in a subset of patients.
Results Cytology samples were collected in 89 of 492 patients. At baseline the mean HLA‐DR expression was higher in the CYCLOKAT® (84,345 AUF vs 46,888 AUF) arm. Notably, the mean HLA‐DR expression increased with baseline CFS grade (grade 2: 48,343; grade 3: 56,749; grade 4: 127,623). At month 6, CYCLOKAT® significantly reduced the HLA‐DR expression (‐50896 AUF vs ‐1192 AUF, p=0.022). The efficacy of CYCLOKAT® on improving CFS [as measured by mean change (delta of CYCLOKAT® over vehicle) and % achieving ≥ 2 grade improvement] increased with the CFS grade at baseline (grade 2‐4: 0.22 and 33.6% vs 21.8%, grades 3‐4: 0.32 and 40.4% vs 27.7%, grade 4: 0.77 and 48.8% vs 19.5%, p<0.05 for all comparisons).
Conclusion The demonstrated correlation between HLA‐DR expression and CFS support the role of inflammation in DED and justifies the need for anti‐inflammatory therapy. The benefit of CYCLOKAT® appears to be greatest in patients with severe DED.
Commercial interest
PurposeThe treatment of severe keratitis in Dry eye disease (DED) represents a real therapeutic challenge. The effect of Ikervis®, an unpreserved 1 mg/mL ciclosporin A cationic emulsion, in this condition was evaluated.MethodsSansika study was a 12 month phase III, multicenter, double‐masked, vehicle controlled, in which 246 DED patients with severe keratitis (corneal fluorescein staining, CFS, grade 4 on modified Oxford scale), were randomised to one drop of Ikervis® or vehicle daily at bedtime for 6 months. Vehicle patients switched to Ikervis® after 6 months.ResultsThe proportion of patients achieving by M6 at least a two‐grade improvement in CFS and a 30% improvement in symptoms [Ocular Surface Disease Index (OSDI)] was 28.6% with Ikervis® vs 23.1% with vehicle, p = 0.326. There was a greater improvement in Ikervis® treated patients over vehicle in mean CFS change from baseline (CFB) at M6 (−1.81 vs −1.48, p = 0.037). The mean OSDI CFB was −13.6 with Ikervis® and −14.1 with vehicle at M6, p = 0.858. There was a reduction in the ocular surface inflammation assessed with Human Leukocyte Antigen‐DR (HLA‐DR) expression in favour of Ikervis® at M6 (p = 0.021). Post hoc analysis showed a greatest proportion of patients achieving a 3‐grade improvement in CFS with Ikervis® over vehicle (28.8% vs 9.6%) at M6.ConclusionsThis study confirmed the positive benefit/risk ratio of Ikervis® for the treatment of severe keratitis in DED. The availability in Europe of Ikervis® represents a significant progress in the management of this disease.
PurposeThe objective of this study was to compare the efficacy and safety of a polyethylene glycol/propylene glycol based eye drop (PEG/PG; Systane® Ultra) to an osmoprotective‐carboxymethylcellulose based eye drop (CMC/O; Optive®) in patients with dry eye.MethodsThis was a multicenter, observer masked, parallel‐design study, subjects were randomized to PEG/PG or CMC/O QID for 35 days (Phase 1) and then as needed for 55 days (Phase 2). Eligible subjects were diagnosed with dry eye and exhibited signs and symptoms at screening. Supportive efficacy assessments included the total ocular staining score (TOSS) score change from baseline to Day 90 (15‐point Oxford scale).ResultsDemographic characteristics were similar between the PEG/PG (n = 46) and CMC/O groups (n = 48). The efficacy of PEG/PG was similar to CMC/O at Day 90 (LS mean treatment difference in TOSS score change from baseline to Day 90 of −0.10 units in favor of PEG/PG). In addition, ocular surface staining associated with dry eye decreased following treatment with PEG/PG with a mean TOSS score change from baseline at Day 90 of −2.7 units. No treatment‐related serious adverse events were reported. Five subjects discontinued due to treatment‐related AEs (2 PEG/PG and 3 CMC/O subjects).ConclusionsPEG/PG based drop demonstrated comparable efficacy to the CMC/O based drop after 90 days treatment with a favorable safety profile in patients with dry eye.
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