Modified Sodium hyaluronate conjugated to riboflavin (Har® 0.1 %) as lubricant eyedrops in the treatment of dry eye: A prospective randomised study
Ontology highlight
ABSTRACT:
SUBMITTER: Caruso C
PROVIDER: S-EPMC11336708 | biostudies-literature | 2024 Jul
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:BackgroundAn artificial-tear formulation containing the dual polymers hydroxypropyl guar (HPG) and hyaluronic acid (HA) is approved for the treatment of dry-eye disease (DED). The present study compared the efficacy and safety of the HPG-HA dual-polymer formulation vs a sodium hyaluronate (SH)-containing artificial-tear formulation in patients with DED.MethodsIn a prospective, 6-week, multicenter, double-masked, parallel-group study, patients with DED aged ≥18 years and total ocular surface staining (TOSS) score ≥4 and ≤9 were randomized (1:1) to receive either HPG-HA or SH four times a day for 42 days. Changes from baseline in TOSS (primary end point), impact of dry eye on everyday life (IDEEL) treatment-satisfaction scores (effectiveness and inconvenience), and tear-film breakup time (TFBUT) at day 42 were assessed using a fixed-sequence testing strategy. Noninferiority was assessed on the primary end point based on the upper limit of two-sided 95% CIs for mean treatment difference (HPG-HA or SH) <2 units.ResultsIn total, 99 patients were randomized (HPG-HA, n= 50; SH, n= 49). At day 42, the least square (LS) mean ± SE change from baseline in TOSS was -1.16±0.24 and -0.92±0.23 in the HPG-HA and SH groups, respectively, and the treatment difference was -0.24±0.33 (95% CI -0.90 to 0.42). Noninfe-riority was demonstrated as the upper limit of the 95% CI was <2 units. LS mean change from baseline at day 42 for HPG-HA vs SH was -3.18 (P=0.4817) in IDEEL treatment-effectiveness scores, -12.56 (P=0.0001) in treatment-inconvenience scores, and 0.30 seconds (P=0.5789) in TFBUT.ConclusionThe HPG-HA dual-polymer formulation was noninferior to the SH lubricant eye-drops for improvement in ocular surface staining in DED. HPG-HA did not show improvement over SH in IDEEL treatment-satisfaction scores. No new safety findings were reported.
| S-EPMC6287663 | biostudies-literature
Project description:PurposeCompare 0.30% sodium hyaluronate (0.30%HA) ocular gel with 0.18%HA eye drops in terms of improvement of ocular signs and symptoms, in patients with moderate to severe dry eye disease (DED).MethodsThis was a multicentric, randomized, investigator-masked, non-inferiority, comparative study conducted over 84 days. Three visits were scheduled, testing fluorescein corneal and conjunctival staining (Oxford and Van Bijsterveld scores), tear film break-up time (TBUT), Schirmer test, DED symptoms, 5-Item-Dry-Eye-Questionnaire (5-DEQ), patient and investigator satisfaction and frequency of instillation.ResultsAt Day 35 (D35) and Day 84 (D84), both groups (n = 35 each) had a significant improvement in corneal staining (p < 0.001) with no inter-group difference. Van Bijsterveld score improved earlier (D35) for 0.30%HA suggesting a faster effect on conjunctival epithelium healing. There was no difference between the two concentrations in terms of TBUT or Schirmer improvements; however, the Schirmer test increase was only significant for 0.30%HA at D35 (p = 0.040). At D35 and D84, both groups showed similar improvements of DED symptoms and DEQ-5 score. Furthermore, treatment satisfaction was similar for the 2 formulations suggesting that daily use of 0.30%HA do not cause gel-related blurred vision disturbances. Frequency of instillation was similar for both groups.ConclusionOur study demonstrates the non-inferiority of 0.30%HA gel compared to 0.18%HA solution in patients with moderate to severe DED. Because of its gel formulation and higher HA concentration providing prolonged comfort without causing visual disturbances, 0.30%HA gel might be adapted for bedtime use or during the day in more severe conditions.
| S-EPMC9834324 | biostudies-literature
Project description:BackgroundDry eye disease is a significant disease in Singapore. While there have been studies using allogenic cord serum for the treatment of dry eye disease, treatment of dry eyes with allogenic umbilical cord plasma drops has yet to be started in Singapore.PurposeTo evaluate the effectiveness of umbilical cord plasma eyedrops for the treatment of recalcitrant dry eyes in a local Singaporean context.MethodsThis is an observational, longitudinal, interventional study for dry eye patients who did not show clear improvement after standard therapy. Patients were recruited from 2020 to 2023 from the dry eye clinic of the Singapore National Eye Center. Umbilical cord plasma was delivered frozen to patients and stored in home freezers. All participants underwent a standardized clinical evaluation for dry eye, and data were collected.ResultsThere were 40 participants (7 males and 33 females). The duration of follow-up was 5.52 ± 1.57 months. Kerato-epitheliopathy staining score, TBUT (tear breakup time), and SPEED (Standard Patient Evaluation of Eye Dryness Questionnaire) scores significantly improved after treatment. No statistically significant improvement was found in terms of visual acuity, according to Schirmer's score.ConclusionCord plasma eye drops significantly improved kerato-epitheliopathy staining scores in recalcitrant dry eye patients. Allogeneic plasma is a promising form of treatment for recalcitrant dry eye.
| S-EPMC10648694 | biostudies-literature
Project description:PurposeTo analyze the protective effects of diquafosol eyedrops on the ocular surface following femtosecond laser-assisted cataract surgery (FLACS).DesignA prospective, randomized contralateral study.MethodsBilateral FLACS with a trifocal IOL (PanOptix) implantation was performed in 40 eyes in 20 patients (10 males, 10 females, average age 68.8 ± 6.3 years old). Patients received 3% diquafosol eyedrops six times daily in one randomly chosen eye (diquafosol group), and physiological saline six times a day in the other eye (control group). Other medication included 1.5% levofloxacin, 0.1% dexamethasone and 0.1% diclofenac three times daily in both eyes. The pre and post-operative tear break-up time (BUT), superficial punctate keratopathy (SPK) scores and visual function were compared between both eyes, and all patients answered the dry-eye-related quality of life score (DEQS) questionnaire.ResultsThe BUT between groups was similar pre-operatively and on the first day post-op; however, the BUT was statistically longer in the diquafosol group compared to saline at 1 week (5.5/3.7 s) and 2 weeks (4.8/3.0 s) (p < 0.05). There was no difference in the SPK score, best corrected distance visual acuity, tear meniscus height, contrast sensitivity, DEQS and Schirmer test at all time points. Spherical aberration was statistically lower in the diquafosol group at 1 week. The protective effects of diquafosol on the BUT was more pronounced in patients with a pre-operative BUT of less than 5 s compared with those with a BUT longer than 6 s.ConclusionsDiquafosol eyedrops prevented the shortening of the BUT following FLACS, even in patients with short pre-operative BUT values.
| S-EPMC9572360 | biostudies-literature
Project description:PurposeWe investigate the efficacy of 0.03% topical tacrolimus eyedrops for the treatment of dry eye in graft versus host disease (GVHD) patients resistant/intolerant to 0.05% topical cyclosporine.MethodsForty-three patients were enrolled in this prospective study. After completing a 1-year run-in period of using artificial tears, 50% autologous serum eyedrops, and punctal plug occlusion, all the symptomatic patients (n=29) were treated with 0.05% topical cyclosporine (Restasis(®); Allergan, Inc.). After 1 month, the patients who presented topical or systemic intolerance to cyclosporine were instructed to instill 0.03% topical tacrolimus once a day for 3 months (n=14). All the patients were allowed to continue with their basal dry eye treatment. Visual acuity, fluorescein staining, Schirmer test, fluorescein tear break-up time, and tear meniscus height measurement were evaluated fortnightly (minimum 3 months). Subjective assessments of symptoms were also reported at the beginning and at the end of the study.ResultsDry eye symptoms and signs improved statistically (P<0.05) and significantly with tacrolimus and cyclosporine topical treatment. No significant differences were observed between both the groups. The mean follow-up time was 12.14±2.69 months (range 10-18 months).ConclusionThe findings of this prospective pilot study suggest that cyclosporine-intolerant patients with dry eye associated with GVHD can be effectively treated with topical tacrolimus.
| S-EPMC3787325 | biostudies-literature
Project description:PurposeWe aimed to compare the physicochemical properties and in vivo efficacy of commercially available nanoemulsion cyclosporine A (CsA) eyedrops in benzalkonium chloride (BAC)-induced dry eye disease (DED).MethodsParticle size analysis was performed on conventional 0.05% CsA (Restasis, C-CsA) and two new types of 0.05% CsA eyedrops based on a self-nanoemulsifying drug delivery system (SNEDDS, SNEDDS-N and -T). Turbidometry, pH measurements and instability indices of each CsA solution were measured. DED was induced with BAC, and animals were treated with vehicle or CsA preparations. Tear volume and fluorescein staining scores were evaluated on days 7 and 14. Eyes were enucleated and subjected to IHC, TUNEL staining, periodic acid-Schiff (PAS) staining, real-time PCR and western blotting.ResultsBoth SNEDDSs had lower and more uniform particle size distribution than C-CsA, and a similar optical density to phosphate-buffered saline and stable pH, in contrast to the high turbidity and unstable pH of C-CsA. Aqueous tear volume and fluorescein staining scores were improved in C-CsA- and SNEDDS-treated mice. Numbers of PAS-positive goblet cells and levels of inflammatory mediators were decreased by both C-CsA and SNEDDS, although SNEDDS resolved inflammation more effectively than C-CsA.ConclusionsCyclosporine A eyedrops with SNEDDS have improved physicochemical properties and treatment efficacy in BAC-induced DED.
| S-EPMC6860930 | biostudies-literature
Project description:A contact lens is an attractive tool for the delivery of ophthalmic drugs, but it has several issues such as the burst release of drugs and the limited drug loading capacity. To overcome these limitations, we developed a cholesterol-hyaluronate (C-HA) micelle-embedded contact lens for efficient hydrophobic drug loading and long-term controlled drug delivery. The contact lens was fabricated via photopolymerization of hydroxyethyl methacrylate (HEMA) using ethylene glycol dimethacrylate (EGDMA) as a cross-linker. The C-HA micelle-loaded contact lens showed statistically significant improvement in wettability and mechanical strength, maintaining the optical transmittance. In vitro drug release tests revealed the controlled delivery of cyclosporine for more than 12 days. Furthermore, the Schirmer tear test, corneal fluorescein staining, and MMP9 fluorescein analysis confirmed its therapeutic effect on dry eye syndrome in disease model rabbits.
| S-EPMC9064448 | biostudies-literature
Project description:BackgroundThe efficacy of two artificial tears, carboxymethylcellulose (CMC) and hyaluronate (HA), was compared in the treatment of patients with dry eye disease.MethodsWe conducted a systematic review and meta-analysis on randomized controlled trials in the PubMed, Embase, Cochrane Library, and ClinicalTrials.gov databases. The efficacy was compared in terms of the mean change from baseline in tear break-up time. The meta-analysis was conducted using both random and fixed effect models. The quality of the selected studies was assessed for risk of bias.ResultsFive studies were included involving 251 participants. Random effect model meta-analysis showed no significant difference between CMC and HA in treating dry eye disease (pooled standardized mean difference [SMD]=-0.452; 95% confidence interval [CI], -0.911 to 0.007; P=0.053). In contrast, fixed effect model meta-analysis revealed significant improvements in the CMC group when compared to the HA group (pooled SMD=-0.334; 95% CI, -0.588 to -0.081; P=0.010).ConclusionThe efficacy of CMC appeared to be better than that of HA in treating dry eye disease, although meta-analysis results were not statistically significant. Further research is needed to better elucidate the difference in efficacy between CMC and HA in treating dry eye disease.
| S-EPMC5305660 | biostudies-literature
Project description:This systematic review and meta-analysis compares sodium hyaluronate (HY) with non-HY based artificial tears in the treatment of dry eye syndrome. A literature search for clinical trials comparing HY against non-HY preparations was conducted across PubMed, Cochrane Central Register of Controlled Trials and Scopus databases from inception up to May 2016. Majority of the 18 studies selected for review showed superiority of HY in improving ocular staining and symptoms. Randomized controlled trials (RCTs) examining Schirmer's I (SH) and tear breakup time (TBUT) underwent further meta-analyses with calculation of pooled standardized mean differences (SMDs) with 95% confidence intervals (CIs). 7 RCTs including 383 eyes randomized to HY and 596 eyes to non-HY preparations underwent meta-analysis for SH. 9 RCTs including 458 eyes randomized to HY and 651 eyes to non-HY preparations underwent meta-analysis for TBUT. By fixed-effects modelling, HY demonstrated greater improvement of SH compared to non-HY preparations (SMD, 0.238; 95% CI, 0.107 to 0.369; p < 0.001). By random-effects modelling, HY demonstrated less improvement of TBUT (SMD, -0.566; 95% CI, -1.099 to -0.0336; p = 0.037). In summary, neither preparation was shown to be consistently superior across all outcome measures. The difference in effect between preparations on SH and TBUT was not clinically significant.
| S-EPMC5567178 | biostudies-literature
Project description:IntroductionDry eye disease (DED) is a multifactorial condition of the ocular surface (OS) characterized by loss of tear film homeostasis, ocular discomfort, and vision disturbances. Most available ocular lubricants target the aqueous deficiency of the tear, restoring only this layer, leaving the tear lipid stratum deficient, as occurs in most patients with evaporative DED. An innovative propylene glycol-hydroxypropyl guar enriched with a phospholipid nanoemulsion (PG-HPG-PH-N) is indicated to restore deficiencies in both the lipid and aqueous layers of the tear film, and its composition was designed to increase lubricant retention on the OS. The purpose of this study was to evaluate, through the Ocular Surface Disease Index (OSDI) and clinical assessment, the treatment of patients who had DED due to aqueous deficiency arising from mixed or evaporative DED subtypes with a PG-HPG-PH-N ocular lubricant at a reduced frequency of twice a day, in a prospective, multicenter, and single-arm study.MethodsPatients were screened from days - 7 to 0, and from day 1 (baseline and first day of treatment) to day 28 of treatment with this lubricant. After visit 1 (screening visit, days - 7 to 0), designed as pre-treatment OS assessment, patients returned to their research center on days 14 and 28 of treatment for a complete assessment, including anamnesis, the OSDI, corrected visual acuity, tear breakup time (TFBUT), OS staining evaluation, tolerability index, and environmental exposure questionnaire.ResultsSeventy patients were enrolled in this study (60 women, 10 men), with a mean age of 45 (range 27-64) years. TFBUT results showed an improvement in tear film stability as vital dyes sodium fluorescein and lysamine green showed a decrease in corneal staining after 14 and 28 days of treatment. No significant adverse events were reported, demonstrating the good tolerability of the lubricant.ConclusionsThe PG-HPG-PH-N nanoemulsion can be considered to be a safe and effective ocular lubricant for treating DED due to aqueous deficiency, both mixed and evaporative subtypes.Trial registrationBrazilian National Research Ethics Commission (ReBEC registration number 16055).
| S-EPMC11564604 | biostudies-literature