Cecile Maissa

The TFOS International Workshop on Contact Lens Discomfort: report of the contact lens interactions with the tear film subcommittee.

Department of Ophthalmology, New Zealand National Eye Centre, University of Auckland, Auckland, New Zealand School of Optometry and Vision Science, University of New South Wales, Sydney, New South Wales, Australia Schepens Eye Research Institute and Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts Optometric Technology Group Research & Consultancy, London, United Kingdom Centre for Contact Lens Research, School of Optometry and Vision Sciences, University of Waterloo, Waterloo, Ontario, Canada Glasgow Caledonian University, Glasgow, United Kingdom University of Miami, Miller School of Medicine Department of Ophthalmology, Bascom Palmer Eye Institute, Miami, Florida Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan

Contact lens wear affects tear film evaporation.

Purpose. The aim of the study was to measure tear film evaporation of both contact lens wearers (CLW) and nonwearers. The hypotheses tested were that (i) amongst CLW tear film evaporation was higher when contact lenses are worn and (ii) tear film evaporation of CLW was higher than nonwearers in the absence of contact lenses. Methods. Tear film evaporation rate was measured at 30% and 40% mean humidity. The subjects were divided into 3 groups: (i) CLW wearing contact lenses (n = 111 subjects or 222 eyes), (ii) CLW having not worn contact lenses on the day of the visit (CLW no CL n = 129 subjects or 258 eyes), and (iii) Non-contact lens wearers (NW) (n = 139 subjects or 278 eyes). Results. The rate of evaporation was similar for the right and left eyes at both humidities. The rate of evaporation was significantly higher for the CLW, than for both CLW no CL and NW. The decrease in the rate of evaporation between the dry (30%) and normal (40%) environmental conditions was significantly lower for the CLW than for the NW. Further, the evaporation rate was significantly greater for the CLW, even after 1 day without contact lens wear, than for the nonwearers. Conclusions. The investigation demonstrates that the rate of evaporation is higher in the presence of a contact lens; the effect may be associated with tissue and/or tear film changes as it is, in part, still present 24 hours after contact lens wear. Wearing contact lenses in normal humidity conditions (40%) produces a greater evaporation than that experienced by non-contact lens wearers in low humidity (30%). This could explain the higher prevalence of dry eye complaints among CLW than amongst nonwearers. The study results support the hypothesis of increased evaporation as a contributing factor to contact lens induced dry eyes.

Tear film dynamics and lipid layer characteristics--effect of age and gender.

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.

Tear film evaporation—Effect of age and gender

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.

Contact lens-induced circumlimbal staining in silicone hydrogel contact lenses worn on a daily wear basis.

Objectives: The principal objective of the study was to measure the conjunctival staining produced in the circumlimbal region by silicone hydrogel contact lenses with different edge designs. The secondary objective was to investigate the association between circumlimbal staining and comfort. Methods: Four silicone hydrogel contact lenses: ACUVUE OASYS (knife edge design), AIR OPTIX, Biofinity (chisel edge rounded edge combination), and PureVision (rounded edge design), and 1 hydrogel contact lens, ACUVUE 2 (knife edge design), were tested. The study was conducted on a cohort population of 27 established soft contact lens wearers, who wore each contact lens type, in a random order, for a period of 10 (±2) days. Circumlimbal staining was measured in a double-masked fashion through image analysis of digital photographs of lissamine green taken under controlled experimental conditions. Results: The results obtained showed that contact lens edge design was the primary factor controlling circumlimbal staining for silicone hydrogel lenses: a rounded edge away from the ocular surface produced the lowest staining (average, 0.19%) and a knife edge in close apposition to the ocular surface produced the highest staining (average, 1.34%). Contact lens material rigidity was also identified to affect circumlimbal staining and an inverse association between circumlimbal staining and contact lens comfort was demonstrated: the rounded edge design produced the lowest comfort (72 of 100) and the knife edge design produced the highest (87 out of 100). Conclusion: Soft contact lens wear induces circumlimbal staining, the level of staining being influenced by the contact lens edge design. However, high level of circumlimbal staining is not associated with decreased comfort.

Effect of castor oil emulsion eyedrops on tear film composition and stability.

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 4h 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 4h 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.

Symptomatic relief associated with eyelid hygiene in anterior blepharitis and MGD.

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). Conclusions: 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.

Eyelid margin modification associated with eyelid hygiene in anterior blepharitis and meibomian gland dysfunction.

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. Conclusion: 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.

Contact lens lipid spoliation of hydrogel and silicone hydrogel lenses.

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.

Long term effects of the daily wear of senofilcon a silicone hydrogel contact lenses on eyelid tissues.

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® 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: 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.