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Maissa C.,OTG Research and Consultancy | Maissa C.,Alcon | Guillon M.,OTG Research and Consultancy | Cockshott N.,OTG Research and Consultancy | And 3 more authors.
Optometry and Vision Science | Year: 2014

PURPOSE: The purpose of the study was to measure contact lens lipid spoliation of silicone hydrogel PureVision (balafilcon A) and hydrogel Acuvue 2 (etafilcon A) contact lenses worn for 10 hours single use (DD) and 7 days of extended wear (EW). METHODS: Two similar study populations (DD, n = 55; EW, n = 53), were enrolled at four study sites. In each population, a bilateral, randomized, crossover (lens material), subject-masked experimental design was followed. Worn contact lenses were analyzed for lipid uptake using high-performance liquid chromatography by two laboratories: Alcon Laboratories (right lens total uptake) and OTG Research & Consultancy (left lens total uptake and individual lipid classes). RESULTS: Lipid uptake was different for the two materials: total lipid (p < 0.007), cholesterol esters (p < 0.001), cholesterol (p < 0.001 EW only), and triglycerides/phospholipids (p < 0.001) were higher for balafilcon A, whereas fatty acid (p < 0.0025 EW only) was higher for etafilcon A. The ratio of the extracted lipids was also different: higher percentages of triglycerides/phospholipids (p < 0.001) and cholesterol (p < 0.001 EW only) for balafilcon A and higher percentages of fatty acids/di- and monoglycerides (p < 0.014) for etafilcon A. CONCLUSIONS: Total lipid uptake was highly material dependent. Both laboratories measured a greater uptake of lipids by the silicone hydrogel than the hydrogel material, a difference that was evident after only 10 hours of DD. Total lipid uptake was greater after 7 days of EW compared with 10 hours of DD. Of interest for contact lens spoliation and its avoidance was the differential lipid uptake profile, indicating material selectivity. Whereas greater differentiation between materials was possible after 7 days of EW for each material, the lipid uptake profile was similar for DD and EW, indicating a greater material effect than a wear modality effect. © American Academy of Optometry.


Maissa C.,OTG Research and Consultancy | Guillon M.,OTG Research and Consultancy | Simmons P.,Allergan, Inc. | Vehige J.,Allergan, Inc.
Contact Lens and Anterior Eye | Year: 2010

Purpose: An emulsion eyedrop containing castor oil has been shown to modify the tear film lipid layer and increase tear film stability. The primary objectives of this investigation were to measure the prevalence of castor oil in the tear fluid over time and quantify the effects on the lipid layer. A secondary objective was to quantify the initial effects on ocular symptomatology. Methods: The investigation was an open label pilot study on 5 normal and 10 dry eye subjects. A single eyedrop (Castor oil emulsion, Allergan) was instilled in each eye; the tear film appearance and composition were monitored for 4. h via in vivo visualisation using the Tearscope™ and post in vivo tear samples analysis by HPLC. Results: Combined results for both normal and dry eye subjects showed that castor oil was detected up to 4. h after a single eyedrop instillation and associated with an increase in the level of tear film lipid. The relative amount of various lipid families was also changed. An increase in tear lipid layer thickness was significant up to one hour post-instillation for the symptomatic sub-population. The changes in tear film characteristics were associated with significantly lower symptoms up to four hours post-instillation for the symptomatic sub-population. Conclusion: This pilot investigation showed that castor oil eyedrops achieved a residence time of at least four hours post-instillation, producing a more stable tear film and an associated significant decrease in ocular symptoms over the entire follow-up period for the symptomatic subjects. © 2009 British Contact Lens Association.


Guillon M.,OTG Research and Consultancy | Maissa C.,OTG Research and Consultancy | Wong S.,OTG Research and Consultancy
Eye and Contact Lens | Year: 2012

Objective: To assess the changes in eyelid margins associated with eyelid hygiene using Blephaclean eye pads to manage anterior blepharitis or meibomian gland dysfunction (MGD) associated with dry eye complaints. METHOD: The investigation was a bilateral, prospective, interventional, open-label investigation of 3-month duration. The test population included dry eye sufferers with at least mild symptoms (Ocular Surface Disease Index ≥ 13) who presented with mild to moderate anterior blepharitis or MGD. Eyelid hygiene was intensive (twice a day) for the initial 3 weeks and a maintenance regimen (once a day) for the remainder of the study. At each visit, a detailed assessment of eyelid margins was performed. This assessment included the rating of lashes contamination, lid margin foam, droplet, redness and staining, and meibomian gland blockage, dropout, and expression. RESULT: Forty subjects aged 22 to 74 years (54 ± 15 years) were enrolled of whom 39 completed the investigation. The product usage revealed good overall compliance throughout the study. The results revealed a significant improvement in eyelid margin status. Significant (P<0.001) decrease in contamination of eyelashes and meibomian gland blockage were recorded at the completion of the initial 3-week intensive phase and maintained over the 3-month study during the maintenance phase. Meibomian gland expression, indicative of the glands functionality, was also significantly better at the completion of both study phases (intensive P=0.003; maintenance P=0.001). A decrease in eyelid margin staining was also observed but was only significant at the 3-month follow-up at the completion of the maintenance phase. Concuusion: The results showed that eyelid hygiene with Blephaclean wipes by subjects with anterior blepharitis or MGD significantly improved the status of the eyelid margin tissues including the meibomian glands. The data confirmed the efficiency of the clinical methodology put forward of 3 weeks of intensive use (twice a day) of eyelid wipes followed by maintenance use (once a day) and that approach achieved a rapid improvement in tissue status and gland patency. © 2012 Lippincott Williams & Wilkins.


Guillon M.,OTG Research and Consultancy | Maissa C.,OTG Research and Consultancy | Wong S.,OTG Research and Consultancy
Eye and Contact Lens | Year: 2012

Objective: The principal objective of this investigation was to assess the symptomatic relief associated with eyelid hygiene using Blephaclean eye pads, a cosmetic product, to manage anterior blepharitis or Meibomian gland dysfunction (MGD) associated with dry eye complaints. METHOD: The investigation was a bilateral, prospective, interventional open label investigation of 3-month duration. The test population was made up of dry eye sufferers with at least mild symptoms (Ocular Surface Disease Index [OSDI] ≥13) who presented with mild to moderate anterior blepharitis or MGD. Eyelid hygiene was intensive (twice a day) for the initial 3 weeks and a maintenance regimen (once a day) for the remainder of the study. At each visit, a detailed assessment of symptomatology was carried out. The assessment included the reporting of overall symptomatology with the OSDI questionnaire, of comfort and specific symptoms at the end of the day on 100-point visual analog scales and of specific MGD-related symptoms on forced choice 5-point scales. RESULT: Forty subjects aged 22 to 74 years (54±15 years) were enrolled, of whom 39 completed the investigation. The product usage revealed good overall compliance throughout the study. The results revealed significant improvement in symptomatology. A significant (P<0.001) decrease in overall symptomatology was recorded (Mean OSDI: baseline=30, day 21=18, day 90=19; Symptomatic status: baseline 100%, day 21 55%, day 90 54%) associated with significant (P<0.001) increase in the end of day comfort (Mean score: baseline=56, day 21=67, day 90=67) and decrease in end of day dryness (Mean score: baseline=55, day 21=42, day 90=41). ConcuusionS: The results showed that eyelid hygiene with Blephaclean wipes by subjects with anterior blepharitis or MGD significantly decreased their associated symptomatology and increased their ocular comfort. The data confirmed the efficiency of the clinical methodology, put forward of 3 weeks of intensive use (twice a day) of eyelid wipes followed by maintenance use (once a day); that approach achieved a rapid symptomatic improvement that was maintained over time. © 2012 Lippincott Williams & Wilkins.


Maissa C.,OTG Research and Consultancy | Guillon M.,OTG Research and Consultancy
Contact Lens and Anterior Eye | Year: 2010

Purpose: Dry eye disease is significantly more prevalent in older subjects and among them more marked in women than men. Further, it is established that the tear film dynamics of dry eye sufferers is different to that of normal. It is therefore postulated that the greater prevalence of dry eye problems with advancing age is at least in part related to poorer tear film dynamics. Methods: Tear film dynamics (non-invasive break up time) and lipid characteristics (lipid layer thickness and contamination) were assessed using the Tearscope lighting system. Results: 160 Subjects less than 45 years old and 58 subjects aged 45 years or more formed the study populations. The tear film stability was mostly influenced by age; the break up time was statistically significantly shorter for the older age group (p<0.001). The lipid layer was also significantly thinner (p=0.013) for the subjects aged 45 years or older with a very marked synergic effect of age and gender. The lipid layer of older women was significantly thinner and more contaminated than that of younger women (p=0.002 and <0.001) and of older men (p=0.034 and 0.004). Conclusions: Aging of the tear film is characterised by its destabilisation associated with significant changes in the tear lipid layer producing less protection from evaporation in the older population; the observed changes are more marked in women than in men. The findings have significant implications for the management of presbyopic dry eye sufferers, for whom decreasing evaporative problems is essential. © 2010 British Contact Lens Association.


Guillon M.,OTG Research and Consultancy | Maissa C.,OTG Research and Consultancy | Ho S.,Allergan Europe
Contact Lens and Anterior Eye | Year: 2010

The objective was to compare the effect on conjunctival tissues of the repeated use, over a one-month period, of Optive compared to Hylocomod eyedrops by a population of dry eye sufferers. The rationale for the study was that among dry eye sufferers who attend eye care practices for symptomatic relief, a large number present with conjunctival anomalies evidenced by tissue staining and that conjunctival recovery is essential to their successful long term management. The hypothesis tested was that the decrease in conjunctival staining with Optive is at least as good, and possibly greater, than that with Hylocomod. The cohort population was made up of 47 subjects (11 male and 26 female) aged 42±16 years with at least mild dry eye symptoms and conjunctival and/or corneal staining. The population included contact lens wearers (n=26) and non-wearers (n=21). The subjects were randomly allocated to use one of the two study products; they were instructed to use the products as often as needed but at least three times a day. Conjunctival staining was rated on forced choice scales and measured objectively using digital photographs and image analysis. The findings showed that, whereas the staining at the start of the investigation was similar (p=0.318-0.664), staining after one month of use was significantly less with Optive than Hylocomod (p=0.028-0.002). The results demonstrated that the regular use of Optive over one month was significantly superior to Hylocomod in improving conjunctival status by producing a greater reduction in the staining of dry eye sufferers. © 2010 British Contact Lens Association.


Guillon M.,OTG Research and Consultancy
Eye and Contact Lens | Year: 2013

The current literature review was intended to investigate whether the use of silicone hydrogel contact lenses has resulted in improved comfort compared with that of hydrogel contact lenses when both are used for daily wear. The conclusion reached is that silicone hydrogel contact lenses, which were initially developed to eliminate hypoxia during overnight wear, have not significantly improved comfort compared with the comfort achieved with hydrogel contact lenses when worn on a daily wear basis, even though a body of the published literature would suggest to the contrary. A careful review and consideration of the literature demonstrates that the relative comfort achieved with the two types of contact lenses is in fact highly dependent on the study methodology: Although refitting studies have concluded enhanced comfort with silicone hydrogels, the more robust study designs involving concurrent controls and masking were not able to show a difference, and some even concluded an inferior performance. Evidence-based review has however clearly demonstrated that comfort cannot be considered in isolation but is contact lens specific and depends on the material surface and bulk properties, lens design characteristics, and modality of use of the contact lens, and may also be significantly influenced by the replacement frequency and interaction with any lens care system that may be used. © 2013 Lippincott Williams & Wilkins.


Guillon M.,OTG Research and Consultancy | Maissa C.,OTG Research and Consultancy
Contact Lens and Anterior Eye | Year: 2012

Purpose: Eyelid changes have been reported with silicone hydrogel contact lenses. It is hypothesized that those changes are associated with the mechanical interaction between the contact lens front surface and eyelid tissues and, are specific to contact lens type rather than a general effect of the lens category. The purpose of this study was to assess the effect of refitting into a silicone hydrogel on a daily wear basis to current contact lens wearers, lapsed wearers and neophytes on eyelid physiology. Methods: The investigation was a 2-year prospective investigation of ACUVUE® OASYS(R) with HYDRACLEAR® Plus (senofilcon A) used with care systems, representative of current practice. Results: 90 subjects were enrolled of whom 64 subjects completed the investigation. The results obtained were as follows:. (i)For current non-wearers, lid hyperaemia (p<0.001) was statistically significantly lower and there was no difference in papillae (p=0.078) at the end of the 24-month period of wear compared with baseline.(ii)For the established current wearers, lid hyperaemia (p<0.001) and the papillae response (p=0.001) were statistically significantly lower at the end of the 24-month period of wear than at baseline. Conclusions: The results of the study demonstrated that senofilcon A, worn on a daily wear basis and replaced every 2 weeks, did not produce any eyelid tissue changes in previous non-contact lens wearers at baseline and revealed no change or a slight improvement of the eyelid tissues of established contact lens wearers. © 2012 .


Guillon M.,OTG Research and Consultancy | Maissa C.,OTG Research and Consultancy
Contact Lens and Anterior Eye | Year: 2010

Purpose: Dry eye is more prevalent in older patients and among them more marked in women than men. The increase in dry eye with aging is traditionally thought to be associated with a decrease in tear production enhanced by hormonal changes. Clinical evidence of an abnormal lipid production system in older patients, in particular women is established. It is therefore postulated that the greater prevalence of dry eye problems in an older population has an evaporative component. Methods: Tear film evaporation was measured with the Oregon Health Sciences University Evaporimeter at 30% and 40% humidity. Results: 160 subjects less than 45 years old and 57 subjects aged 45 years or more formed the study population. The results revealed a significant effect of age (p<0.001), gender (p<0.001) and their interaction (p<0.001): (i) the rate of evaporation was higher in the older age group at both humidities; (ii) the rate of evaporation was overall higher for women; and (iii) the synergic effect of age and gender was very marked: the rate of evaporation of older women was 34-80% higher than that of older men and 36-69% than younger women. Conclusions: Aging of the tear film includes a significant evaporative component characterised by higher tear film evaporation for the over 45 compared to younger people. Further, in the over 45 years of age, a significantly greater tear film evaporation was recorded in women than men. The findings have significant implications for the management of presbyopic dry eye sufferers. © 2010 British Contact Lens Association.


PubMed | OTG Research and Consultancy
Type: Journal Article | Journal: Eye & contact lens | Year: 2012

The principal objective of this investigation was to assess the symptomatic relief associated with eyelid hygiene using Blephaclean eye pads, a cosmetic product, to manage anterior blepharitis or Meibomian gland dysfunction (MGD) associated with dry eye complaints.The investigation was a bilateral, prospective, interventional open label investigation of 3-month duration. The test population was made up of dry eye sufferers with at least mild symptoms (Ocular Surface Disease Index [OSDI] 13) who presented with mild to moderate anterior blepharitis or MGD. Eyelid hygiene was intensive (twice a day) for the initial 3 weeks and a maintenance regimen (once a day) for the remainder of the study. At each visit, a detailed assessment of symptomatology was carried out. The assessment included the reporting of overall symptomatology with the OSDI questionnaire, of comfort and specific symptoms at the end of the day on 100-point visual analog scales and of specific MGD-related symptoms on forced choice 5-point scales.Forty subjects aged 22 to 74 years (5415 years) were enrolled, of whom 39 completed the investigation. The product usage revealed good overall compliance throughout the study. The results revealed significant improvement in symptomatology. A significant (P<0.001) decrease in overall symptomatology was recorded (Mean OSDI: baseline=30, day 21=18, day 90=19; Symptomatic status: baseline 100%, day 21 55%, day 90 54%) associated with significant (P<0.001) increase in the end of day comfort (Mean score: baseline=56, day 21=67, day 90=67) and decrease in end of day dryness (Mean score: baseline=55, day 21=42, day 90=41).The results showed that eyelid hygiene with Blephaclean wipes by subjects with anterior blepharitis or MGD significantly decreased their associated symptomatology and increased their ocular comfort. The data confirmed the efficiency of the clinical methodology, put forward of 3 weeks of intensive use (twice a day) of eyelid wipes followed by maintenance use (once a day); that approach achieved a rapid symptomatic improvement that was maintained over time.

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