treatment with sodium hyaluronate and HPMC/dextran center drops is useful for treating patients with dry eye ascribable to LTD. however, sodium hyaluronate caused a significantly ( phosphorus < 0.05 ) greater increase in NIBUT values than HPMC/dextran in such patients. Both sodium hyaluronate and HPMC/dextran caused a meaning ( p < 0.05 ) improvement in NIBUT and symptoms. Mean ( SD ) NIBUT in the sodium hyaluronate group was 3.2 ( 1.0 ), 6.4 ( 2.8 ), 5.5 ( 1.9 ), 5.3 ( 1.3 ) and 3.9 ( 1.7 ) randomness at 0, 15, 30, 60 and 90 min, respectively, compared with 3.6 ( 1.9 ), 5.5 ( 3.2 ), 5.0 ( 1.5 ), 4.4 ( 2.2 ) and 3.5 ( 1.2 ) south in the HPMC/dextran group. however, increase in NIBUT was significantly ( phosphorus < 0.05 ) greater and longer in the sodium hyaluronate group than in the HPMC/dextran group. This was a randomized, double‐blind, controlled, exploratory study. A entire of 10 patients with dry eye due to LTD were treated as follows : one dismiss of hypotonic 0.18 % sodium hyaluronate in one center and one drop of isotonic 0.3 % hydroxypropyl‐methylcellulose ( HPMC ) /0.1 % dextran in the other eye. Non‐invasive tear film break‐up time ( NIBUT ) evaluated by using a bust telescope with grid form and immanent ocular symptoms of dry eye were assessed at 15, 30, 60 and 90 min after instillation. As a consequence, the determination of this cogitation was to assess the performance profile of hypotonic 0.18 % sodium hyaluronate eye drops after a single instillation in patients with dry eye due to LTD. Hydroxypropyl‐methylcellulose ( HPMC ) /dextran eye drops were used as the mention product.

sodium hyaluronate as a tear‐replacement center dangle is widely used in the treatment of ATD, as indicated in several well‐controlled studies. 3, 4, 5 however, little is known on the efficacy profile of sodium hyaluronate in evaporative dry eye due to lipid tear insufficiency ( LTD ). LTD is one of the authoritative causes of tear film instability. It is caused by meibomian gland abnormality, which results in miss of or abnormal lipid tear layer, instability of the pluck film and shorten of tear break‐up clock ( TBUT ). 2, 6 Causes of dry eye have been classified into two groups—namely, aqueous tear‐deficient dry eye ( ATD ) and tear‐sufficient evaporative dry eye. 1 artificial tears are wide used to treat ATD. In most austere cases, treatment with non‐preserved center drops is mandatary to avoid the perniciousness of preservative when using the eye drops at frequent intervals. The efficacy of non‐preserved artificial tears is well recognised in this case. 2 As this was an exploratory trial, no prior hypothesis was chosen and no sample size was calculated. No basal efficacy parameter was chosen. however, NIBUT was considered to be the most significant assessment argument in this particular trial. commercially available study products—namely, Vislube/Vismed ( 0.18 % sodium hyaluronate, molecular weight 1.2×10 6 Da, TRB Chemedica, Munich, Germany ) and BionTears ( 0.3 % HPMC/0.1 % dextran, Alcon, Forth Worth, Texas, USA ) were used. Vislube/Vismed is a patent hypotonic ( 150 mOsm/kg ) solution containing the electrolytes potassium, calcium, magnesium, sodium and chloride. BionTears is an isotonic solution containing sodium, potassium, calcium, magnesium, zinc, chloride and bicarbonate as electrolytes. Both products are preservative unblock. Ophthalmic examination and coverage of adverse event throughout the sketch were assessed as regards base hit. All the examinations and tests were recorded by the same tax assessor ( PP ). Both the tax assessor and patients were blinded to the treatment groups ( double blind ). NIBUT was measured using the Tearscope Plus ( Keeler, Windsor, UK ). 10, 11 The tax assessor ( PP ) measured the interval between a accomplished wink and the appearance of the beginning randomly distorted power system convention on the corneal tear film, and calculated the average value of three measurements. This test was performed before any eye drops or dye stain was instilled into the eye. Rose Bengal was assessed using the 0–9 scoring system of Bijsterveld. 9 The fluorescein staining scoring system ( score 0–12 ) was calculated using type, extent and depth of corneal erosion ( character : micropunctate = 1, macropunctate = 2, coalescence = 3 and patch = 4 ; extent ( percentage of coat area ) : 1–15 % = 1, 16–30 % = 2, 31–45 % = 3 and > 45 % = 4 ; and depth : superficial epithelial punctate = 1, deep delayed epithelial punctate = 2, immediate localised stromal glow = 3 and contiguous soft stromal glow = 4 ). The intensity of five dry eye symptoms ( included discomfort, harshness, dispassion, grittiness and burning, as described in the McMonnies questionnaire 7 ) was assessed on five classify 0 millimeter ( no symptom ) to 100 millimeter ( hard symptom ) ocular analogue scales. 8 An median symptom score ( maximum 100 millimeter ) was calculated. ocular examinations included ocular acuteness, external and slit lamp examen on hat, lashes and meibomian glands, staining with fluorescein and rose Bengal, NIBUT, TBUT and tear volume ( Schirmer ‘s I test ). A total of 10 patients with evaporative lipid‐deficient dry center syndrome due to pure LTD according to the definition of Lemp 1 were enrolled in the survey. Inclusion criteria were patients aged ⩾18 years, with meibomian gland dysfunction ( MGD ), with NIBUT < 10 randomness in each eye, Schirmer 's I test > 10 millimeter wetting/5 min in each eye and at least one of the following symptoms of dry eye : tenderness, harshness, sobriety, grittiness and burn. excommunication criteria were dangerous dry eye, ocular surgery within the past 4 months before inclusion, use of conserve eye drops within the past 2 weeks before inclusion, wearing contact lens, abnormality of the nasolacrimal drain apparatus and hypersensitivity to hyaluronic acid or any component or, excipient used in the study. thereafter, at day 1, eligible patients were randomly allocated to receive one drop of sodium hyaluronate in one eye, whereas the other center received one drop of HPMC/dextran. Another person instilled the assigned merchandise in accord with the randomization mesa so that the tax assessor was blinded to the treatment received. This was a randomized, double‐blind, controlled, exploratory learn. Before trigger of the discipline, the inform consent form and protocol were approved by the committee for the protective covering of human participants in research at the Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand. The study was conducted in accord with dear clinical practice guidelines for the evaluation of medicative products and the Declaration of Helsinki. At the day 0 sojourn, patients were checked for inclusion and ejection criteria, and the follow service line assessments for parameters were performed : dry eye questionnaire, incision lamp interrogation, non‐invasive tear film break‐up clock time ( NIBUT ) using a Tearscope and TBUT using fluorescein, corneal staining with fluorescein, staining with rose Bengal and tear volume ( Schirmer I test ). Tear movie imbalance can be best shown by NIBUT using a pluck scope with a power system model. The non‐contact nature of the tear oscilloscope without any substrate put into the eye allows us to evaluate the tear film in the natural environment.

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No adverse consequence in any group was observed by the detective or reported by the patient throughout the learn. Both treatments were well tolerated and did not affect ocular acuity except temporally blurred vision immediately after instillation. calculate 2 Results of symptoms on the ocular analogue scale ( VAS ) ( think of ( SD ), in millimeter ) after a unmarried instillation of 0.18 % sodium hyaluronate ( SH ) in one eye and 0.3 % hydroxypropyl‐methylcellulose ( HPMC ) /0.1 % dextran in the other eye. *p < 0.05 versus service line. Looking at symptoms on the ocular analogue scale ( fig 2 ), a meaning ( phosphorus < 0.05 ) improvement was seen in both groups at all time points. however, no significant difference between the two groups was observed for this parameter. Each symptom individually ( internet explorer, tenderness, harshness, dryness, grittiness and cut ) showed a profile of improvement exchangeable to that of average symptoms. After a one instillation of artificial tear, hateful ( SD ) NIBUT in the sodium hyaluronate group was 3.2 ( 1.0 ), 6.4 ( 2.8 ), 5.5 ( 1.9 ), 5.3 ( 1.3 ) and 3.9 ( 1.7 ) mho at 0, 15, 30, 60 and 90 min compared with 3.6 ( 1.9 ), 5.5 ( 3.2 ), 5.0 ( 1.5 ), 4.4 ( 2.2 ) and 3.5 ( 1.2 ) s in the HPMC/dextran group, respectively. Both sodium hyaluronate and HPMC/dextran caused a significant ( phosphorus < 0.05 ) improvement in NIBUT ( libyan islamic fighting group 1 ) at 15, 30 and 60 min compared with the baseline. however, improvement observed in the sodium hyaluronate group was greater at all time points and longer ( > 90 min ) than that in the HPMC group ( 60 min ). Differences were significant at 30 minute ( p = 0.04 ) and 60 min ( phosphorus = 0.005 ) in privilege of sodium hyaluronate and close to significance at 15 min ( phosphorus = 0.08 ) and 90 min ( p = 0.07 ). table 1 shows that the two treatment groups were homogeneous for demographic characteristics. Both groups had merely minimal fluorescein and rose Bengal staining. half of the patients in both groups had minimal superficial punctate fluorescein staining ( < 15 % surface area ), and two and three patients in the sodium hyaluronate and HPMC groups, respectively, had minimal rose Bengal staining ( score 1–2 ) .

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Dry center was defined by the National Eye Institute/Industry Workshop as a disorderliness of the pluck movie due to tear insufficiency or excessive dehydration. 1 ATD can be caused by insufficiency of aqueous production from the lacrimal gland resulting from an incendiary serve such as Sjögren ‘s syndrome or decrease in corneal sensitivity due to many reasons including senesce, a deflective surgical procedure or systemic diseases. 2 evaporative tear‐sufficient dry eye can be caused by many factors such as increased exposure, decrease in bally, anatomical reference abnormality, decrease in corneal sensitivity and MGD. 2 MGD causes abnormal lipid tear layers, leading to instability of the rip film 12, 13 and abnormal pluck film spreading. 14 This induces ocular surface abnormality, which may result in ocular surface damage 6 and ocular discomfort such as a burn sense, pique and bleary sight. Dry eye due to LTD can be diagnosed by rapid TBUT, whereas aqueous output remains normal. 2 In this study, we included such patients, on the basis of shortstop TBUT values ( < 10 s ) and normal values of tear volume ( Schirmer 's I test > 10 millimeter wetting/5 min ), to assess whether sodium hyaluronate and HPMC/dextran could increase tear movie stability and relieve the symptoms. Tear film break‐up time was determined using a non‐invasive proficiency, frankincense avoiding the instillation of fluorescein, as fluorescein itself has been shown to shorten the TBUT 15, 16 and modify the effect of the sodium hyaluronate solution being instilled. 17 In this study, we besides showed that TBUT values were lower than those obtained with the non‐invasive proficiency ( NIBUT ), where no fluorescein dye was used at service line ( table 1 ). previous reports of sodium hyaluronate in ATD 3, 4, 5, 18 yielded excellent results compared with reference treatments or saline. Hypotonic sodium hyaluronate solutions were shown to further improve the result in such patients compared with normal isotonic eye drops. 3 sodium hyaluronate ( molecular slant 1×106 Da ) at a concentration of 0.1 % was besides shown to importantly increase the rip break‐up prison term in patients with dry eye and in the convention population compared with saline or sodium hyaluronate at lower concentrations. 15, 19 These findings suggest that sodium hyaluronate at a assiduity of at least 0.1 % is required to delay the break‐up of the precorneal tear film in patients with ATD. In this study, we showned that a one topical lotion of 0.18 % sodium hyaluronate and HPMC/dextran besides importantly improved rip film stability in patients with tear dysfunction due to lipid deficit, although these patients have normal tear volume. furthermore, 0.18 % sodium hyaluronate caused a importantly prolonged TBUT compared with HPMC/dextran for up to 90 min after instillation of a individual drop. This consequence might be explained by the peculiar properties of sodium hyaluronate. Sodium hyaluronate is a biopolymer that occurs naturally in all vertebrates—for case, in the vitreous body of the center, the extracellular matrix of the bark and in the synovial fluid. It has alone characteristics that make it ideal to improve tear film stability, including viscoelastic rheologic behavior, 20 mucomimetic properties, 21 water‐retention properties 22 and the ability to delay vaporization of the aqueous component of the tear film ( water‐retention properties ). Owing to the increased aqueous tear vaporization in lipid tear dysfunction, 23, 24 tear osmolarity in LTD and MGD was reported to be higher than normal. 23, 25 This suggests that hypotonic sodium hyaluronate eye drops may be superscript to isotonic eye drops in patients with MGD or LTD. In cosmopolitan, treatment of LTD is more unmanageable than ATD because artificial lipid‐replacement therapy is not presently available. Treatment strategies include the try to improve the function of the meibomian gland using affectionate compression, oral tetracycline 13 and emulsion center drops. 14, 26, 27, 28 In this study, we showed that non‐preserved aqueous sodium hyaluronate and HPMC/dextran solutions significantly improved the tear stability and symptoms of patients with LTD, with importantly better findings in the sodium hyaluronate group. This find oneself may be utilitarian in clinical practice because these non‐preserved artificial tears are commercially available.

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In an earlier study on patients with ATD, Mengher et aluminum 15 reported an improvement in TBUT for 40 minute after a individual instillation of one dribble of a 0.1 % sodium hyaluronate solution. The longer duration of impression ( 90 min ) observed in our study can be attributed to the higher concentration of sodium hyaluronate used ( 0.18 % v 0.1 % ), and besides to the different type of dry eye treated. Although 0.18 % sodium hyaluronate gave more golden results than HPMC/dextran in our study, the results indicated that the broadly recommended treatment regimen of 3–4 instillations per day is not sufficient to provide the patient with adequate relief. These patients should receive discussion at least every 1 or 2 hydrogen before the effect becomes apparent. In this study, the symptoms of dry eye were immediately and significantly alleviated for up to 90 min after instillation in both groups. however, the efficacy tended to reduce after 60 minute. This resultant role is similar to that obtained by Mengher et aluminum 15 in patients with ATD. There was no burning sensation or serious complication arising from both non‐preserved eye drops. In decision, both sodium hyaluronate and HPMC/dextran are beneficial not alone to patients with ATD for increasing tear volume but besides to patients with dry center due to LTD because they improve tear film stability and symptoms. In this test, sodium hyaluronate caused well better relief than HPMC/dextran in such patients. however, the results would need to be confirmed in another study with a larger issue of patients to far assess the long‐term benefits of non‐preserved eye drops in this indication .

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