Query: hylan M dry eyes drop

title: Safety and efficacy of autologous serum eye drop for treatment of dry eyes in graft versus host disease
abstract: To evaluate the treatment of autologous serum eye drops (ASED) on dry eyes in patients with graft versus host disease (GVHD)  A retrospective chart review of 35 patients with a history of ocular GVHD following hematopoietic stem cell transplantation that used ASED to alleviate dry eye symptoms was performed. Patients were categorized into three different groups. If patients had available ophthalmic data before and after starting treatment was group 1 (n 14) had available ophthalmic data after starting treatment in group 2 (n 10) and had available ophthalmic data before treatment or did not have any data after starting treatment in group 3 (n 11) Data were collected on patient's age, gender, primary diagnosis, visual acuity and fluorescein corneal staining were collected on individual eyes in order to evaluate the efficacy of the ASED on alleviating dry eye related signs and symptoms.  No adverse ocular effect from the ASED was found in our series (except one fungal keratitis) All patients reported either improvement (55% or stability (45% in their ocular symptoms upon the use of ASED. In patients with available data before and after starting treatment, the corneal staining score improved by a median of 1 (p 0.003) and the LogMAR visual acuity had a non significant improvement.  In our study, ASED used by patients with ocular GVHD were both safe and effective. ASED should be considered in patients with GVHD who suffer from dry eyes.

title: Short Term Results of Trial of Topical Insulin for Treatment of Dry Eyes in Diabetics.
abstract: To assess the short term effects of topical insulin (TI) 1 unit/drop 4 times per day for 4 weeks on the symptoms and signs of diabetic with dry eye disease (DED) METHODS In this randomized, double blind interventional study, diabetics with DED aged 18 to 60 years were randomly assigned to TI or standard artificial tears (SAT) Baseline Ocular Surface Disease Index (OSDI) Schirmer I test (ST) tear break up time (TBUT) and ocular Sjogren's International Collaborative Clinical Alliance (SICCA) score were compared 4 weeks after treatment.  A total of 160 participants (involving 320 eyes) received either TI (n=80) or SAT (n=80) After 4 weeks of treatment, a significant number of participants in both TI and SAT groups showed improvement in their OSDI score, 66% and 63% respectively (P=0.0001) but were not significantly better than each other (P=0.453) However, most participants in both groups showed worsening of ST and TBUT (P>0.05) Most of the participants in both groups showed no change in their ocular SICCA score (P>0.05)  The study has shown a significant and similar improvement in the OSDI score for TI 1 unit/drop four times daily and SAT in treating diabetics with DED. Further research is required to understand the long term effects of TI on the ocular surface.

title: Fingerprick autologous blood for dry eyes and persistent epithelial defects
abstract: Autologous serum has been used effectively to treat severe dry eye syndrome1 (DES) and persistent epithelial defects2 (PED) However, difficulty obtaining funding and delays in production often make it unfeasible for acute cases. The authors report on finger prick autologous blood (FAB)3 as an alternative treatment option. Patients cleaned a finger with an alcohol steret. Next, they produced a drop of blood using a diabetic lancet and applied it to their lower fornix. They repeated this technique to apply FAB four times per day to each eye. A different finger was used for each eye to reduce any risk of cross infection.

title: Influence of Perfluorohexyloctane Eye Drops on Tear Film Thickness in Patients with Mild to Moderate Dry Eye Disease: A Randomized Controlled Clinical Trial.
abstract: The aim of this mechanistic clinical study was to explore the effect of water free perfluorohexyloctane eye drops on tear film thickness (TFT) in patients with dry eye disease (DED)  Forty eight patients with mild to moderate DED participated in this randomized, single masked, observer blinded parallel group study in a 1:1 ratio to receive either perfluorohexyloctane or unpreserved 0.9% saline solution (Hydrabak(r) Thea, France) eye drops 4 times daily in both eyes for 4 weeks. A custom built ultrahigh resolution optical coherence tomography system was used to measure TFT. Furthermore, evaluation of lipid layer thickness (LLT) and noninvasive tear film breakup time, as well as standard clinical tests for signs and symptoms of DED were performed.  Mean TFT and LLT at baseline were comparable between the 2 treatment groups. After a single drop instillation, perfluorohexyloctane eye drops temporarily increased TFT immediately. After multiple dosing, perfluorohexyloctane eye drops gradually increased TFT over time with a maximum effect at the end of the study (least square mean difference: 6.42% P 0.0142 at week 4) LLT values measured before drop instillation showed a more prominent increase in LLT for perfluorohexyloctane eye drops (13.36% 26.33% vs. 3.21% 28.65% All other parameters got better in both treatment groups with no statistical difference between groups.  These results demonstrate that perfluorohexyloctane eye drops increase TFT as well as LLT over time. These tear film reestablishing attributes are in line with the mode of action of perfluorohexyloctane eye drops to avoid evaporation through stabilization of the lipid layer.

title: Osmoprotectants, carboxymethylcellulose and hyaluronic acid multi ingredient eye drop: a randomised controlled trial in moderate to severe dry eye
abstract: PurposeTo assess the safety and efficacy of an eye drop combining osmoprotectants, carboxymethylcellulose and hyaluronic acid (O/CMC/HA) in reducing symptomatic, moderate to severe dry eye, compared with HA.MethodsIn this investigator masked, randomised study, patients instilled 1 2 drops/eye of O/CMC/HA or HA (2 6 times/day) for 3 months.  mean change in Global Ocular Staining Score (GOSS) from baseline at day 35. Noninferiority of O/CMC/HA was tested in the per protocol population; if achieved, superiority was tested in the intent to treat population. Secondary efficacy endpoints: mean change from baseline in GOSS, Ocular Surface Disease Index (OSDI) Schirmer score, tear break up time (TBUT) corneal/conjunctival staining, conjunctival hyperaemia, symptoms, and patient/investigator assessments.ResultsBaseline characteristics were comparable between groups (n=40 each) O/CMC/HA was noninferior (and not superior) to HA based on similar GOSS reductions from baseline at day 35 and month 3 in both groups (P=0.778, day 35, per protocol population) Overall, O/CMC/HA and HA provided similar reductions in OSDI, Schirmer score, TBUT, corneal staining and hyperaemia from baseline at 35 days (P>=0.155) More patients reported less severe stinging/burning, sandiness/grittiness, and painful/sore eyes at month 3 with O/CMC/HA (P<=0.039) and more rated the dropper bottle easy to use (87.5% compared with HA (46.2% P=0.002) Other patient and investigator assessments were similar between groups. O/CMC/HA and HA were well tolerated.ConclusionsO/CMC/HA is noninferior to HA in improving objective signs of dry eye, with potential advantages for subjective symptoms and patient acceptance.

title: Effect of recombinant human nerve growth factor eye drops in patients with dry eye: a phase IIa, open label, multiple dose study
abstract: Dry eye disease (DED) affects more than 14% of the elderly population causing decrease of quality of life, high costs and vision impairment. Current treatments for DED aim at lubricating and controlling inflammation of the ocular surface. Development of novel therapies targeting different pathogenic mechanisms is sought after. The aim of this study is to evaluate safety and efficacy of recombinant human nerve growth factor (rhNGF) eye drops in patients with DED.  Forty consecutive patients with moderate to severe DED were included in a phase IIa, prospective, open label, multiple dose, clinical trial to receive rhNGF eye drops at 20 ug/mL (Group 1: G1) or at 4 ug/mL (Group 2: G2) concentrations, two times a day in both eyes for 28 days (NCT02101281) The primary outcomes measures were treatment emerged adverse events (AE) Symptoms Assessment in Dry Eye (SANDE) scale, ocular surface staining and Schirmer test.  Of 40 included patients, 39 completed the trial. Both tested rhNGF eye drop concentrations were safe and well tolerated. Twenty nine patients experienced at least one AE (14 in G1 and 15 in G2) of which 11 had at least 1 related AE (8 in G1 and 3 in G2) Both frequency and severity of DED symptoms and ocular surface damage showed significant improvement in both groups, while tear function improved only in G1.  The data of this study indicate that rhNGF eye drops in both doses is safe and effective in improving symptoms and signs of DED. Randomised clinical trials are ongoing to confirm the therapeutic benefit of rhNGF in DED.

title: Impact of Nanostructured Lipid Carriers as an Artificial Tear Film in a Rabbit Evaporative Dry Eye Model
abstract: To characterize formulations of nanostructured lipid carriers (NLCs) as an artificial tear film and evaluate their efficacy in protecting the ocular surface epithelial cells from desiccating stress in vivo.  The physicochemical properties of NLCs, produced with components similar to the tear film such as phosphatidylcholine and squalene, were determined. In vitro cytotoxicity of NLCs was evaluated by a short time exposure test in porcine corneal epithelial cells using a methyl thiazol diphenyl tetrazolium bromide assay. The residence time of NLCs in rabbit eyes and the efficacy of NLCs eye drops in protecting the rabbit corneal epithelium from desiccating stress were assessed.  Nanosized NLCs with a mean size of ~39 5 nm and a zeta potential of 30 mV could be produced and formulated into eye drop with a pH of 6.90 0.01, osmolarity of 273 1 mOsm/L, and surface tension of 39 1 mN/m (for air interface) Eye drop formulations of NLCs were nontoxic to porcine corneal epithelial cells. NLCs drops showed higher ocular surface retention and formed a stable corneal film compared with a saline solution. Moreover, NLCs eye drops showed greater efficacy in protecting the corneal surface against desiccating stress compared with a polymer based commercial artificial tear.  NLCs eye drops are biocompatible in rabbit eyes and show potential as a tear replacement vehicle for the treatment of dry eye disease.

title: Combined use of 0.1% fluorometholone and meibomian gland expression improves symptoms of moderate and severe dry eye disease, even in patients with systemic immune disease
abstract: This study prospectively evaluated the effect of 0.1% fluorometholone (FML) combined with meibomian gland expression (MGX) on dry eye disease (DED) and meibomian gland dysfunction (MGD).The study included 48 patients (96 eyes) with moderate to severe DED. The patients were treated with topical FML and MGX. The patients underwent Keratograph 5 M to evaluate quantitatively (THM, BUT, R scan) and semi quantitatively the meibomian gland loss (meiboscore) The methods included slit lamp examination to evaluate meibum quality (meibum score) fluorescein staining and ocular surface disease index (OSDI) questionnaire. All patients (15 patients were also diagnosed with systemic immune disease) completed the study. The Schirmer I test results showed no statistical significance. After treatment, the fluorescein staining score, meibum score and R Scan were decreased from the baseline values at week 2. The meiboscore was decreased at month 3 and the OSDI questionnaire scores were lower than the baseline at month 1. For subjects with systemic immune disease, the fluorescein staining score and meibum score were lower than the baseline. Tear BUT reached peak at month 1 and dropped to baseline at month 3. R Scan and OSDI were decreased at months 1 and 3 compared to the baseline. The Schirmer I Test values and the meiboscore were not different from the baseline. The study demonstrated that 0.1% FML combined with MGX improves symptoms of moderate to severe DED.

title: Effect of lipid based dry eye supplements on the tear film in wearers of eye cosmetics.
abstract: To compare the effects on tear film parameters and contamination in cosmetic eyeliner wearers, after single application of two lipid based dry eye treatments: a lipid containing lubricant eye drop and a phospholipid liposomal spray.  Fifty participants were enrolled in a prospective, randomised, paired eye, investigator masked trial. Pencil eyeliner (Body Shop(r) Crayon Eye Definer) was applied to the upper eyelid periocular skin of both eyes, anterior to the lash line. Baseline tear film quality was assessed fifteen minutes after eyeliner application. A lubricant drop (Systane(r) Balance) was then applied to one eye (randomised) and liposomal spray (Tears Again(r) to the contralateral eye. Tear film contamination, lipid layer grade, non invasive tear film break up time and tear evaporation rate were evaluated fifteen minutes post treatment and compared to pre treatment values.  Pre treatment measurements did not differ between eyes assigned to lubricant drop and liposomal spray. Tear film contamination was observed in a greater proportion of eyes following both treatments (both p<0.05) with no significant difference between treatments (p=0.41) Both treatments improved lipid layer thickness (both p<=0.01) but effected no significant change in non invasive tear film break up time or tear evaporation rate (all p>0.05) Changes in tear film parameters did not differ between treatments (all p>0.05) CONCLUSIONS Both the lipid containing lubricant eye drop and phospholipid liposomal spray result in clinically apparent tear film contamination in eyeliner cosmetic wearers. Although both treatments effected an increase in lipid layer thickness, neither displayed clinical efficacy in improving tear film stability.

title: Safety and tolerability of lifitegrast ophthalmic solution 5.0% Pooled analysis of five randomized controlled trials in dry eye disease
abstract: Characterize the safety and tolerability of lifitegrast ophthalmic solution 5.0% for the treatment of dry eye disease.  Pooled data from five randomized controlled trials were analyzed. Key inclusion criteria were adults with dry eye disease (Schirmer tear test score 1 and 10 mm, eye dryness score 40 (visual analog scale 0 100) corneal staining score 2.0 (0 4 scale) Participants were randomized to lifitegrast ophthalmic solution 5.0% or placebo twice daily for 84 or 360 days. Treatment emergent adverse events and drop comfort scores were assessed.  Overall, 2464 participants (lifitegrast, n 1287; placebo, n 1177) were included. Ocular treatment emergent adverse events occurring in >5% in either group were instillation site irritation (lifitegrast, 15.2% placebo, 2.8% instillation site reaction (lifitegrast, 12.3% placebo, 2.3% and instillation site pain (lifitegrast, 9.8% placebo, 2.1% the most common 5% nonocular treatment emergent adverse event was dysgeusia (lifitegrast, 14.5% placebo, 0.3% The majority of treatment emergent adverse events were mild to moderate in severity. Discontinuation due to treatment emergent adverse events occurred in 7.0% (lifitegrast) versus 2.6% (placebo) of participants (ocular: 5.5% vs 1.5% nonocular: 1.9% vs 1.1% Drop comfort scores with lifitegrast improved within 3 min of instillation and the score at 3 min improved across visits (12 week trials (both eyes, day 84 vs 0) 2.0 vs 3.3; SONATA (day 360 vs 0) right eye, 1.2 vs 1.7; left eye, 1.2 vs 1.8)  Lifitegrast ophthalmic solution 5.0% appeared to be safe and well tolerated for the treatment of dry eye disease. Drop comfort with lifitegrast improved within 3 min of instillation.