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George W Ousler - One of the best experts on this subject based on the ideXlab platform.
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thymosin beta 4 ophthalmic solution for dry eye a randomized placebo controlled phase ii clinical trial conducted using the controlled adverse environment cae model
Clinical Ophthalmology, 2015Co-Authors: Gabriel Sosne, George W OuslerAbstract:Background The purpose of this study was to evaluate the safety and efficacy of thymosin beta 4 ophthalmic solution (RGN-259; Tβ4) in subjects with moderate to severe dry eye using the CAE™ model. Methods This single-center, prospective, double-masked, placebo-controlled Phase II study randomized 72 qualifying subjects 1:1 to receive either 0.1% Tβ4 or placebo treatment for a total of 28 days. The study consisted of six visits over a 32-day period, including a screening visit (day -1), controlled adverse environment challenge (CAE) visits (day 1, day 28), and follow-up visits (days 14, 29, and 30). The primary efficacy endpoints were ocular discomfort scores and inferior Corneal Staining measured at visit 5 on day 29. Secondary endpoints included central and superior Corneal Staining, conjunctival Staining, conjunctival redness, tear-film break-up time, and daily symptom scores recorded over the course of the study. Safety measures included visual acuity, slit-lamp evaluation, conjunctival redness, tear film break-up time, intraocular pressure, dilated funduscopy, and Corneal sensitivity. Results Neither of the primary endpoints, ie, ocular discomfort or inferior Corneal Staining, showed a significant difference between treatment and control groups at visit 5. Despite this, significant differences between treatment groups were observed for a number of secondary endpoints. The discomfort scores in the CAE on day 28 were reduced by 27% in 0.1% Tβ4-treated subjects compared with the placebo group (P=0.0244). Subjects in the 0.1% Tβ4 treatment group also showed statistically significant improvements in central and superior Corneal Staining compared with Staining scores in the control group (P=0.0075 and P=0.0210). No adverse events were observed. Conclusion This study confirms the efficacy of 0.1% Tβ4 as a topical treatment for relief of signs and symptoms of dry eye. Significant improvements in both signs and symptoms of dry eye were observed, and the treatment exhibited a large safety window, with no adverse events reported by any subjects enrolled in the study.
Lyndon Jones - One of the best experts on this subject based on the ideXlab platform.
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geographic distribution of Corneal Staining in symptomatic dry eye
Ocular Surface, 2020Co-Authors: Jill Woods, Natalie Hutchings, Sruthi Srinivasan, Lyndon JonesAbstract:Abstract Purpose To describe the geographic distribution of Corneal fluorescein Staining across the five Corneal zones, among non contact lens wearers who report symptoms of dry eye and determine which Corneal zone most frequently exhibited the worst Staining. Methods Prior studies conducted at the Centre for Ocular Research & Education, Canada, were reviewed for inclusion in the analysis. Each study assessed dry eye symptoms using OSDI and also assessed Corneal fluorescein Staining in five Corneal zones. For each subject, the Corneal zones were ranked 1–5 according to their relative Staining grade, Rank-1 representing the highest grade. Results Data from 13 studies and 368 subjects were included. The total number of zones assigned Rank-1 (worst) Staining was 449 (across 264 subjects). The inferior zone had the most Rank-1 counts of all zones at 193/43%, which involved 52.5% of all subjects. The nasal zone had 77/17% involving 20.9% of subjects, followed by the temporal (69/15.5%, 18.8% subjects) and superior zones (63/14%, 17.1% subjects). The central zone had the lowest count of Rank-1 designations, at only 47/10.5%, involving 12.8% of subjects. Bayesian analysis was used to generate distributions of the credible proportions of subjects likely to present with Staining in a single peripheral zone, with or without central zone Staining. It illustrated that Staining in a peripheral zone without central Staining was more credible. The worst single zone Staining was most likely to present in the inferior zone (67.9%), followed by the nasal zone (11.3%), the superior zone (9.2%), and the temporal zone (5.6%). Conclusion In the presence of dry eye symptoms, the inferior zone typically presents the most severe grade of Corneal Staining, more likely without central zone Staining. This knowledge is valuable when developing a strategy to treat dry eye signs, as the inferior Corneal zone has the highest grade of Staining thus has the potential to exhibit the greatest reduction in Staining post-treatment.
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a novel scale for describing Corneal Staining
Clinical Ophthalmology, 2018Co-Authors: Jill Woods, Desmond Fonn, Jalaiah Varikooty, Lyndon JonesAbstract:The assessment of Corneal Staining is a commonly conducted procedure in both clinical practice and as part of various research studies. Different grading scales are employed by many clinicians and researchers to undertake this procedure for Corneal Staining comparisons between eyes, products and over time. This paper describes the development and use of a grading scale for Corneal Staining undertaken at an academic research site. The scale involves assessment of three factors across five Corneal zones: type, area and depth. Staining type and area are graded on a 0-100 scale, and depth is graded on a 0-4 scale. These factors can be combined to create a three- or two-factor Staining grade, or the factors may be reported individually. An additional benefit of this scale is that the Staining scores may be reported by zone as "zone Staining scores" or the scores of zones may be combined to provide an overall Corneal "global Staining score".
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pilot study to determine the effect of lens and eye rinsing on solution induced Corneal Staining sics
Optometry and Vision Science, 2016Co-Authors: Jill Woods, Lyndon JonesAbstract:PURPOSE The main purpose of this study was to determine whether two interventions (rinsing the lens before lens insertion and rinsing the ocular surface post-lens removal) had any impact on solution-induced Corneal Staining (SICS). In addition, the presence of hyper-reflective epithelial cells in the presence of SICS was investigated. METHODS Twenty subjects wore new balafilcon A lenses, which had been soaked overnight in a multipurpose care product containing polyhexamethylene biguanide for 2 hours. The study was conducted across three phases. In phase 1 (investigator and subject masked, randomized eye), one lens was rinsed with nonpreserved saline before lens insertion. In phase 2 (investigator masked, randomized eye), one eye was rinsed with nonpreserved saline after lens removal, before Staining assessment. Corneal Staining was recorded as the percentage area of the cornea exhibiting superficial punctate Staining. In both phases, ocular comfort and presence of specific symptoms were captured. In phase 3, there was no randomized treatment; confocal images of the epithelium were obtained after 2 hours of wear. RESULTS In phase 1 (lens-rinse), there was no significant difference in Staining between the treated and untreated eyes (84 vs. 92%, respectively; p = 0.06). In phase 2 (eye-rinse), there was also no significant difference between the treated and untreated eye (86 vs. 86%, p = 0.92). Most subjects were asymptomatic. In phase 3, images of hyper-reflective cells were captured in 97% of the eyes imaged. CONCLUSIONS The two rinsing procedures did not affect the level of the SICS response. Hyper-reflective epithelial cells were found to be present in a significant number of eyes exhibiting SICS, and their presence warrants further investigation.
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human Corneal epithelial cell shedding and fluorescein Staining in response to silicone hydrogel lenses and contact lens disinfecting solutions
Current Eye Research, 2014Co-Authors: Maud Gorbet, Rachael C Peterson, Craig A Woods, Lyndon Jones, David J Mccanna, Desmond FonnAbstract:Purpose: A pilot study was conducted to evaluate human Corneal epithelial cell shedding in response to wearing a silicone hydrogel contact lens/solution combination inducing Corneal Staining. The nature of ex vivo collected cells Staining with fluorescein was also examined. Methods: A contralateral eye study was conducted in which up to eight participants were unilaterally exposed to a multipurpose contact lens solution/silicone hydrogel lens combination previously shown to induce Corneal Staining (renu fresh TM and balafilcon A; test eye), with the other eye using a combination of balafilcon A soaked in a hydrogen peroxide care system (Clear Care; control eye). Lenses were worn for 2, 4 or 6 hours. Corneal Staining was graded after lens removal. The Ocular Surface Cell Collection Apparatus was used to collect cells from the cornea and the contact lens. Results: In the test eye, maximum solution-induced Corneal Staining (SICS) was observed after 2 hours of lens wear (reducing significantly by 4 hours; p50.001). There were significantly more cells collected from the test eye after 4 hours of lens wear when compared to the control eye and the collection from the test eye after 2 hours (for both; n =5 ;p50.001). The total cell yield at 4 hours was 813 � 333 and 455 � 218 for the test and control eyes, respectively (N = 5, triplicate, p = 0.003). A number of cells were observed to have taken up the fluorescein dye from the initial fluorescein instillation. Confocal microscopy of fluorescein-stained cells revealed that fluorescein was present throughout the cell cytoplasm and was retained in the cells for many hours after recovery from the Corneal surface. Conclusion: This pilot study indicates that increased epithelial cell shedding was associated with a lens-solution combination which induces SICS. Our data provides insight into the transient nature of the SICS reaction and the nature of fluorescein Staining observed in SICS.
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impact of a rub and rinse on solution induced Corneal Staining
Optometry and Vision Science, 2010Co-Authors: Rachael C Peterson, Desmond Fonn, Craig A Woods, Lyndon JonesAbstract:Purpose. To investigate whether the inclusion of a rub and rinse step before contact lens disinfection has an impact on solution-induced Corneal Staining. Methods. This was a prospective, double-masked, single investigator study. Twenty participants were recruited for two visits, where balafilcon-A lenses were worn bilaterally for 2 h. Each pair of lenses was prepared using two different methodologies. The “control” lens was transferred from the blister pack directly into a storage case containing polyhexamethylene biguanide-based lens care solution. The contralateral “test” lens was rubbed and simultaneously rinsed using the same polyhexamethylene biguanide-based care solution, for either 60 s (visit 1) or 20 s (visit 2). Both lenses were then soaked in the solution overnight. After baseline Corneal Staining assessments, the lenses were inserted following a randomized contralateral model. After 2 h, lenses were removed, Corneal Staining was regraded, and comfort scores were obtained. Results. Rubbed and rinsed test lenses induced significantly less Corneal Staining than control lenses for all participants during visit 1 (mean ± SD: 516 ± 843 vs. 2170 ± 902; p 0.05). Conclusions. Corneal Staining induced after 2 h of lens wear with the combination of balafilcon-A and polyhexamethylene biguanide-based lens care solution can be significantly reduced by including a rub and rinse step before overnight soaking. Further work is required to establish the longevity of this effect during the monthly wearing cycle.
Louis Tong - One of the best experts on this subject based on the ideXlab platform.
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severe dysfunctional tear syndrome patients and resolution of central Corneal Staining retrospective cohort study
British Journal of Ophthalmology, 2020Co-Authors: Zhen Ling Teo, Clarisse Chu, Louis TongAbstract:Purpose Severe dry eye is widely prevalent yet difficult to treat. This study aims to evaluate for improvement in epithelial status and the risk factors for lack of improvement in a cohort of patients in Singapore with severe dry eye. Methods We retrospectively identified 1712 patients with severe dry eye (≥grade 3 Delphi) in at least one eye, referred to a tertiary centre dry eye clinic from 2006 to 2017. We included patients with central Corneal Staining grade of ≥2 at referral and minimum follow-up duration of 6 months (n=407). An epithelial Staining grade of Results The mean follow-up duration was 4.0±2.4 years, with 88.0% (358/407) of patients achieving significant improvement. Various treatment modalities including topical corticosteroids (32.4%), cyclosporine (52.8%) and punctal plugs (24.1%) were used. Risk factors for non-improvement of Staining grade include autoimmune disease (OR 3.2, 95% CI: 1.7 to 6.1), rheumatoid arthritis (RA) (OR 3.4 (1.8 to 6.6)), graft-versus-host disease (GVHD) (OR 3.4 (1.0 to 11.7)), reduced baseline Schirmer’s test (OR 2.1 (1.2 to 3.9)) and reduced tear break up time (OR 2.0 (1.0 to 3.8)). On multivariate analyses, RA and GVHD were still significant risk factors. Gender, age and meibum viscosity were not significantly associated with epithelial Staining grade improvement. Conclusions Overall, a high rate of Corneal epithelial improvement was achieved. Nevertheless, there is an unmet need for more effective measures to reduce epitheliopathy in severe dry eye, especially in patients with systemic immune-mediated disease.
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Corneal Staining characteristics in limited zones compared with whole cornea documentation for the detection of dry eye subtypes
Investigative Ophthalmology & Visual Science, 2013Co-Authors: Beau J Fenner, Louis TongAbstract:RESULTS. Double-zone analysis predicted each subtype of dry eye disease investigated. Aqueous disease was predicted by superior/inferior zones (AUCSup/Inf 0.797 versus AUCTotal 0.816), evaporative disease by inferior/central zones (AUCInf/Cen 0.759 versus AUCTotal 0.778), and mixed disease by superior/inferior, inferior/nasal, and inferior/central zones (AUCSup/Inf 0.765, AUCInf/Nas 0.771, AUCInf/Cen 0.778 versus AUCTotal 0.795). Inferior zone analysis predicted aqueous (AUCInf 0.751 versus AUCTotal 0.750), evaporative (AUCInf 0.756 versus AUCTotal 0.752), and mixed (AUCInf 0.831 versus AUCTotal 0.788) dry eye disease with similar efficacy to complete analysis in diabetic individuals. Inferior zone analysis also predicted aqueous disease in rheumatoid arthritis patients (AUCInf 0.804 versus AUCTotal 0.785), whereas superior zone analysis predicted evaporative disease in thyroid disease patients (AUCSup 0.765 versus AUCTotal 0.752). CONCLUSIONS. Double-zone Corneal Staining predicts the presence of dry eye disease with predictive power similar to complete Corneal analysis. Additionally, subtypes of dry eye can be predicted by single-zone analysis among patients with diabetes (inferior zone), rheumatoid arthritis (inferior zone), and thyroid disease (superior zone). Clinical characterization of dry eye can thus be hastened by limiting Corneal examination to specific zones.
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comparison of Corneal sensitivity tear function and Corneal Staining following laser in situ keratomileusis with two femtosecond laser platforms
Clinical Ophthalmology, 2013Co-Authors: Andrea Petznick, Annabel C Y Chew, Reece C Hall, Cordelia Chan, Mohamad Rosman, Donald T H Tan, Louis Tong, Jodhbir S MehtaAbstract:PURPOSE To evaluate longitudinal changes in Corneal sensitivity, tear function, and Corneal Staining in patients who underwent laser in situ keratomileusis (LASIK) using two different femtosecond lasers. METHODS In a prospective, randomized clinical trial, contralateral eyes of 45 patients underwent flap creation by either VisuMax or IntraLase™ femtosecond laser. Corneal sensitivity, tear break up time (TBUT), Schirmer's test, and Corneal fluorescein Staining were assessed preoperatively and at 1 week, 1 month, and 3 months postoperatively. RESULTS There were no statistical differences in any clinical outcome measure between the two femtosecond lasers (P > 0.05), although there was a trend towards slightly lower reductions for Corneal sensitivity and TBUT in VisuMax-operated eyes. Overall, Corneal sensitivity was significantly reduced at 1 week (P 0.05). CONCLUSION This study showed that changes in Corneal sensitivity, tear function, and Corneal Staining were statistically similar in LASIK using VisuMax and IntraLase femtosecond lasers for flap creation. However, the trend towards faster recovery of Corneal sensitivity and TBUT observed in VisuMax-operated eyes may be attributable to improved technical specifications.
Birgit S Gathof - One of the best experts on this subject based on the ideXlab platform.
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treatment of severe chronic ocular graft versus host disease using 100 autologous serum eye drops from a sealed manufacturing system a retrospective cohort study
British Journal of Ophthalmology, 2016Co-Authors: Volkan Tahmaz, Uta Gehlsen, Laura Sauerbier, Udo Holtick, Lisa Engel, Stela Radojska, Vioricamaria Petrescujipa, Christof Scheid, Michael Hallek, Birgit S GathofAbstract:Background/Aims To analyse patients with chronic ocular graft-versus-host disease (GvHD) under treatment with 100% autologous serum eye drops from a sealed manufacturing system. Methods 17 patients with chronic ocular GvHD received 100% autologous serum eye drops from single use vials manufactured in a sealed system. Retrospective analysis included visual acuity, Corneal Staining, frequency of artificial tears, ocular symptoms by means of a questionnaire and information on subjective side effects and cost compensation. Results Data of prior to autologous serum eye drops therapy and at a 6-month follow-up were obtained. They demonstrated a significant increase in visual acuity (logMAR oculus dexter/right eye (OD) 0.5±0.32 to 0.4±0.3; oculus sinister/left eye (OS) 0.6±0.35 to 0.3±0.35; p=0.177/0.003) and significant improvement in Corneal Staining (Oxford grading scheme: OD from 3±1.03 to 2±1.43, OS from 4±1.0 to 2±1.09, p=0.004/0.001) and ocular symptoms (ocular surface disease index: 88±20.59 to 63±22.77; p=0.02). Frequency of artificial tears was reduced and no side effects were reported. Patient satisfaction was 100%, and cost compensation by health insurance reached 80%. Conclusions 100% autologous serum eye drops using a sealed manufacturing system were efficient in improving the ocular surface, patient symptoms and visual acuity without side effects. It seems to be safe to use 100% autologous serum despite earlier suspicions regarding immune complex accumulations and exacerbation of ocular surface inflammation. The potential effects of serum levels of systemic immunosuppressives through readministration onto the ocular surface need to be elucidated.
Gabriel Sosne - One of the best experts on this subject based on the ideXlab platform.
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thymosin beta 4 ophthalmic solution for dry eye a randomized placebo controlled phase ii clinical trial conducted using the controlled adverse environment cae model
Clinical Ophthalmology, 2015Co-Authors: Gabriel Sosne, George W OuslerAbstract:Background The purpose of this study was to evaluate the safety and efficacy of thymosin beta 4 ophthalmic solution (RGN-259; Tβ4) in subjects with moderate to severe dry eye using the CAE™ model. Methods This single-center, prospective, double-masked, placebo-controlled Phase II study randomized 72 qualifying subjects 1:1 to receive either 0.1% Tβ4 or placebo treatment for a total of 28 days. The study consisted of six visits over a 32-day period, including a screening visit (day -1), controlled adverse environment challenge (CAE) visits (day 1, day 28), and follow-up visits (days 14, 29, and 30). The primary efficacy endpoints were ocular discomfort scores and inferior Corneal Staining measured at visit 5 on day 29. Secondary endpoints included central and superior Corneal Staining, conjunctival Staining, conjunctival redness, tear-film break-up time, and daily symptom scores recorded over the course of the study. Safety measures included visual acuity, slit-lamp evaluation, conjunctival redness, tear film break-up time, intraocular pressure, dilated funduscopy, and Corneal sensitivity. Results Neither of the primary endpoints, ie, ocular discomfort or inferior Corneal Staining, showed a significant difference between treatment and control groups at visit 5. Despite this, significant differences between treatment groups were observed for a number of secondary endpoints. The discomfort scores in the CAE on day 28 were reduced by 27% in 0.1% Tβ4-treated subjects compared with the placebo group (P=0.0244). Subjects in the 0.1% Tβ4 treatment group also showed statistically significant improvements in central and superior Corneal Staining compared with Staining scores in the control group (P=0.0075 and P=0.0210). No adverse events were observed. Conclusion This study confirms the efficacy of 0.1% Tβ4 as a topical treatment for relief of signs and symptoms of dry eye. Significant improvements in both signs and symptoms of dry eye were observed, and the treatment exhibited a large safety window, with no adverse events reported by any subjects enrolled in the study.