Long-term results of treatment with diquafosol ophthalmic solution for aqueous-deficient dry eye

Purpose

To evaluate the preliminary long-term efficacy of diquafosol ophthalmic solution for aqueous-deficient dry eye.

Methods

Fifteen patients with mild-to-moderate aqueous-deficient dry eye were enrolled. After a washout period, the patients were treated with 3 % diquafosol ophthalmic solution for 6 months. We assessed 12 subjective dry eye symptoms, corneal and conjunctival staining with fluorescein, tear film break-up time (BUT), lower tear meniscus height measured with anterior-segment optical coherence tomography, Schirmer’s testing, and adverse reactions at baseline and 1, 3, and 6 months after the start of treatment.

Results

Treatment with diquafosol ophthalmic solution significantly improved dry eye symptoms, corneal staining, BUT, and tear meniscus height at 1 month and maintained the effectiveness for 6 months. Conjunctival staining significantly improved 3 and 6 months after treatment. No significant adverse reactions developed.

Conclusions

Prolonged use of diquafosol ophthalmic solution for 6 months produced significant improvement both subjectively (dry eye symptom score) and objectively (ocular staining score and tear function tests) for aqueous-deficient dry eye.     

Clinical effectiveness of diquafosol ophthalmic solution 3% in Korean patients with dry eye disease: a multicenter prospective observational study

AIM: To investigate the effectiveness of diquafosol ophthalmic solution 3% administered in Korean patients with dry eye disease in real-world clinical settings. METHODS: Diquafosol was administered for 8wk to 3 patient groups who received diquafosol as add-on therapy to existing medication (Add group, n=150); received diquafosol only (Monotherapy group, n=196); or discontinued part of their existing medication in favor of diquafosol (Switch group, n=11). Tear break-up time (TBUT), cornea and conjunctival staining based on National Eye Institute/Industry scoring scheme, subjective symptoms using the Ocular Surface Disease Index (OSDI) questionnaire, and meibum quality and expressibility were evaluated at baseline, week 4, and week 8. RESULTS: The mean TBUT increased (from 3.46, 3.92, and 5.84s, respectively, to 5.15, 5.53, and 8.59s, respectively) and corneal staining score decreased (from 2.23, 2.24, and 3.09, respectively, to 0.85, 0.97, and 1.64, respectively) in a time-dependent manner from baseline to week 8 in all three groups. Conjunctival staining score, OSDI questionnaire, and meibum quality and expressibility improved over time from baseline to week 8 in the Add and Monotherapy groups, but differences were not statistically significant in the Switch group. CONCLUSION: Diquafosol improves subjective symptoms and objective signs in patients treated with existing medicines combined with diquafosol and treated solely with diquafosol. Diquafosol can be used as an effective therapeutic agent for dry eye disease or additionally applied in patients who have insufficient response to existing medicines.     

Changes of tear film lipid layer thickness by 3% diquafosol ophthalmic solutions in patients with dry eye syndrome

AIM: To evaluate the quantitatively changes in lipid layer thickness (LLT) when 3% diquafosol eye drop is used for dry eye patients using the tear film interferometer. METHODS: A total 124 participants (32 males, 92 females; mean age, 28.9y) diagnosed with dry eye disease (DED) received topical instillation of 4 ophthalmic solutions in one eye: diquafosol, normal saline, 0.1% sodium hyaluronate and 0.3% gatifloxacin, in a masked manner. LLT was measured using an interferometer at baseline and 20min after the instillation of each ophthalmic solutions. RESULTS: Changes of LLT after instillation (nm, mean± standard error) were as follows: 12.6±2.0 for diquafosol (P<0.001), 1.2±2.2 for normal saline (P=0.301), 1.5±2.0 for hyaluronate (P=0.495), and 0.5±3.2 for gatifloxacin (P=0.884). CONCLUSION: Topical instillation of diquafosol increases tear film LLT in DED patients. Diquafosol 3% eye drop might be effective treatment option of evaporative DED with meibomian gland dysfunction.     

Clinical evaluation of the additive effect of diquafosol tetrasodium on sodium hyaluronate monotherapy in patients with dry eye syndrome: a prospective,randomized, multicenter study

Purpose

To assess the additive effect of diquafosol tetrasodium on sodium hyaluronate monotherapy in patients with dry eye syndrome.

Methods

This study evaluated 64 eyes of 32 patients (age: 62.6±12.8 years (mean±SD)) in whom treatment with 0.1% sodium hyaluronate was insufficiently responsive. The eyes were randomly assigned to one of the two regimens in each patient: topical administration of sodium hyaluronate and diquafosol tetrasodium in one eye, and that of sodium hyaluronate in the other. Before treatment, and 2 and 4 weeks after treatment, we determined tear volume, tear film break-up time (BUT), fluorescein and rose bengal vital staining scores, subjective symptoms, and adverse events.

Results

We found a significant improvement in BUT (P=0.049, Dunnett test), fluorescein and rose bengal staining scores (P=0.02), and in subjective symptoms (P=0.004 for dry eye sensation, P=0.02 for pain, and P=0.02 for foreign body sensation) 4 weeks after treatment in the diquafosol eyes. On the other hand, we found no significant change in these parameters after treatment in the control eyes.

Conclusions

In dry eyes, where sodium hyaluronate monotherapy was insufficient, diquafosol tetrasodium was effective in improving objective and subjective symptoms, suggesting its viability as an option for the additive treatment of such eyes.     

干眼患者115例的临床特点分析

目的　分析各种类型干眼患者的临床特点。方法　回顾性分析 115例 ( 2 2 9只眼 )干眼患者的临床资料 ,包括症状、病因、全身病、裂隙灯检查、泪膜破裂时间检查 (break uptime,BUT)、基础泪液分泌试验 (SchirmerⅠtest,SⅠt)、反射泪液分泌试验 (SchirmerⅡtest,SⅡt)、角结膜荧光素(fluorescent,Fl)染色、虎红 (rosebangle ,Rb)染色及睑板腺功能的检查。对Sj gren综合征 (Sj grensyndrome,SS)者行血清类风湿因子、自身抗体及涎腺分泌功能检查。结果　 115例中 ,水液缺乏性干眼(aqueousteardeficiency ,ATD)者 5 6例 ( 48 7% ) ,蒸发过强型干眼者 40例 ( 34 8% ) ,混合型干眼者 16例( 13 9% ) ,结膜松弛综合征者 4例 ( 3 5 % )。SS患者 13例 ( 11 3% )。在各型干眼患者中 ,女性多于男性 ,尤其是ATD患者 ,原发性SS ATD患者 10 0 %为女性 ,43例非SS水液缺乏性干眼 (non SSaqueousteardeficiency ,NSTD)者中女性 35例 ( 81 4% )。临床特点 :干涩症状者 6 3例 ( 84 0 % ) ,视疲劳者 5 4例( 72 0 % ) ,异物感者 48例 ( 6 4 0 % ) ,视力波动者 42例 ( 5 6 0 % ) ,睑板腺功能障碍 (meibomainglanddysfunction ,MGD)者 35例 ( 30 4% )。各类型干眼患者的BUT、Rb、Fl间均有明显的相关性 ,Rb与Fl间相关性高 (r =     

Double-masked, placebo-controlled safety and efficacy trial of diquafosol tetrasodium (INS365) ophthalmic solution for the treatment of dry eye

PURPOSE: To investigate the safety and efficacy of diquafosol tetrasodium, a P2Y2 receptor agonist that stimulates fluid and mucin secretion on the ocular surface, as a novel topical treatment of dry eye disease. METHODS: Subjects with dry eye (n=527) were evaluated in a randomized, double-masked, parallel-group trial comparing 24 weeks of treatment with 2 concentrations of diquafosol (1% and 2%) versus placebo instilled 4 times daily. Corneal staining, conjunctival staining, Schirmer tests, and subjective symptoms of dry eye were evaluated. Use of artificial tears was permitted as necessary. RESULTS: Subjects treated with 2% diquafosol had significantly lower corneal staining scores compared with placebo at the 6-week, primary efficacy time point (P<0.001), and superiority continued throughout the 24-week study. Reductions in corneal staining were observed as early as after 2 weeks of treatment, were maintained throughout the 24-week study, and were observed to worsen slightly (toward baseline) when diquafosol treatment was discontinued (week 25). Results for conjunctival staining were consistent with those observed for corneal staining. Schirmer scores at week 6 were significantly higher with diquafosol treatment than with placebo (P相似文献   

长期视屏终端接触者干眼症325例临床分析

目的分析干眼症的临床症状,探讨临床实用的检查方法。方法对325例长期视屏终端接触者干眼症进行临床调查,包括常见症状（眼干、视疲劳,异物感等）,泪膜破裂时间（BUT）、Schirmer试验、角膜荧光染色和睑板腺检查。结果常见症状依次是：眼干涩感（82.5%）、视疲劳（70.2%）、异物感（65.2%）、视物模糊（34.8%）、烧灼感（30.2%）、眼痛（24.3%）、畏光（20.9%）、眼红（16.9%）、眼胀（13.2%）,流泪（11.4%）等。在临床检查中BUT（84.9%）、Schirmer试验（72.0%）阳性率高,睑板腺异常、角膜荧光染色的阳性率较低。结论干眼症的临床症状中以眼干涩、视疲劳、异物感为主,临床检查中BUT、Scbirmer试验阳性率高,可作为干眼症的主要检查方法。     

干眼症患者435例临床症状分析

目的分析不同类型干眼症患者的临床表现及其特点。方法收集2006年10月至2008年2月就诊于我科的435例(870眼)干眼症患者的资料,并进行相关检查,包括裂隙灯检查、角膜荧光素染色、泪膜破裂时间(breakuptime,BUT)检查和基础泪液分泌试验(Schirmer Ⅰtest,SⅠt)。结果435例干眼患者中,眼部不适症状中最多见者为眼部干涩312例和视疲劳308例,其次是眼痒265例,视物模糊/视力下降247例,眼红241例,异物感213例,畏光/流泪和眼痛均为197例,眼烧灼感112例,睫毛上粘有碎屑、球结膜出血和眼睑痉挛者少见。女性发病率多于男性。非-Sjgren综合征眼患者386例,平均年龄(34.70±12.84)岁。BUT≤5s者410例;角膜荧光素染色阳性患者427例;SⅠt≤5mm者335例,6mm≤SⅠt<10mm者83例。结论干眼症患者的临床症状具有多样性特点,尤以眼干涩、视疲劳、眼痒和视物模糊/视力下降最为多见;角膜荧光素染色检查、BUT、SⅠt检查是诊断干眼症的主要依据。