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Treatments for open-angle glaucoma aim to prevent vision loss through lowering of intraocular pressure, but to our knowledge no placebo-controlled trials have assessed visual function preservation, and the observation periods of previous (unmasked) trials have typically been at least 5 years. We assessed vision preservation in patients given latanoprost compared with those given placebo. In this randomised, triple-masked, placebo-controlled trial, we enrolled patients with newly diagnosed open-angle glaucoma at ten UK centres (tertiary referral centres, teaching hospitals, and district general hospitals). Eligible patients were randomly allocated (1:1) with a website-generated randomisation schedule, stratified by centre and with a permuted block design, to receive either latanoprost 0·005% (intervention group) or placebo (control group) eye drops. Drops were administered from identical bottles, once a day, to both eyes. The primary outcome was time to visual field deterioration within 24 months. Analyses were done in all individuals with follow-up data. The Data and Safety Monitoring Committee (DSMC) recommended stopping the trial on Jan 6, 2011 (last patient visit July, 2011), after an interim analysis, and suggested a change in primary outcome from the difference in proportions of patients with incident progression between groups to time to visual field deterioration within 24 months. This trial is registered, number ISRCTN96423140. We enrolled 516 individuals between Dec 1, 2006, and March 16, 2010. Baseline mean intraocular pressure was 19·6 mm Hg (SD 4·6) in 258 patients in the latanoprost group and 20·1 mm Hg (4·8) in 258 controls. At 24 months, mean reduction in intraocular pressure was 3·8 mm Hg (4·0) in 231 patients assessed in the latanoprost group and 0·9 mm Hg (3·8) in 230 patients assessed in the placebo group. Visual field preservation was significantly longer in the latanoprost group than in the placebo group: adjusted hazard ratio (HR) 0·44 (95% CI 0·28–0·69; p=0·0003). We noted 18 serious adverse events, none attributable to the study drug. This is the first randomised placebo-controlled trial to show preservation of the visual field with an intraocular-pressure-lowering drug in patients with open-angle glaucoma. The study design enabled significant differences in vision to be assessed in a relatively short observation period. Pfizer, UK National Institute for Health Research Biomedical Research Centre.

Aim The purpose of this study was to conduct and interpret a pooled 12-month analysis of two prospective, multi-center, randomized, double-masked, controlled trials designed to assess the efficacy and safety of the travoprost intracameral implant (slow-eluting [SE] implant in development as a new therapeutic and fast-eluting [FE] implant included for masking purposes) in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT). Methods Subjects with OAG or OHT, on 0–3 intraocular pressure (IOP)-lowering medications, baseline unmedicated mean diurnal IOP of ≥ 21 mmHg, and IOP ≤ 36 mmHg at each baseline diurnal timepoint, received either a travoprost implant and twice-daily (BID) placebo eye drops or BID timolol 0.5% eye drops and a sham procedure. Subjects were followed through 12 months and assessed for IOP, reduction in topical IOP-lowering medications, and safety parameters including treatment-emergent adverse events (TEAEs). IOP at 8AM was prospectively collected at all study visits through 12 months and diurnal IOP, measured at 8AM, 10AM, and 4PM, was prospectively collected at baseline, day 10, week 6, and months 3 and 12. Results A total of 1150 subjects were randomized (385 FE implant, 380 SE implant, and 385 sham/timolol) across the two trials. Statistical non-inferiority to timolol and clinically relevant reductions in 8AM IOPs were demonstrated at month 12. In more detail, both implant groups demonstrated statistical non-inferiority to timolol and clinically relevant reductions from baseline in mean diurnal IOP at all visits over the 12-month evaluation period when diurnal IOP was collected. Additionally, both implant groups demonstrated robust treatment effect based on 8AM average IOP from day 10 through the specified visit which ranged from day 10 to month 12 from 6.9 to 8.5 mmHg in the FE implant group; 6.8 to 8.5 mmHg in the SE implant group; and 7.3 to 7.5 mmHg in the sham/timolol group. With regards to reduction in topical pharmacotherapy, at month 12, 77.6% of FE and 81.4% of SE implant eyes were completely free of all topical IOP-lowering medications and a significantly greater proportion of FE and SE implant eyes (89.9% and 93.0%) versus sham/timolol eyes (66.9%) were on the same or fewer topical IOP-lowering medications compared with pre-study ( p <  0.0001). Furthermore, of subjects on topical IOP medications at screening, a significantly greater proportion of FE implant (80.2%) and SE implant (85.1%) eyes versus sham/timolol (22.8%) eyes were on fewer topical IOP-lowering medications at month 12 compared with pre-study ( p <  0.0001). Lastly, of SE implant eyes on same or fewer topical IOP-lowering medications at month 12, the average through month 12 decreased by 0.9 medications, and of those SE implant eyes on fewer topical IOP-lowering medications compared with pre-study, the average through month 12 decreased by 1.4 medications. The most common TEAEs related to study treatment were hyperemia (conjunctival or ocular), iritis, and IOP increased. Conclusion The travoprost intracameral implant demonstrated robust IOP-lowering efficacy that was sustained and statistically non-inferior to timolol over the entire 12 months, resulting in a significant reduction in topical IOP-lowering medication use, with the majority of SE implant eyes remaining completely free of all topical IOP-lowering medications. In addition, the implant demonstrated a favorable safety and tolerability profile based on this pooled 12-month analysis of two pivotal trials. Trial Registration ClinicalTrials.gov identifiers NCT03519386 (registered May 09, 2018) and NCT03868124 (registered March 08, 2019).

Background/aimsTo report the protocol of a trial designed to evaluate the efficacy, safety and mechanism of action of low-dose atropine (0.01%) eye-drops for reducing progression of myopia in UK children.MethodsMulticentre, double-masked, superiority, placebo-controlled, randomised trial. We will enrol children aged 6–12 years with myopia of −0.50 dioptres or worse in both eyes.We will recruit 289 participants with an allocation ratio of 2:1 (193 atropine; 96 placebo) from five centres. Participants will instil one drop in each eye every day for 2 years and attend a research centre every 6 months. The vehicle and preservative will be the same in both study arms.The primary outcome is SER of both eyes measured by autorefractor under cycloplegia at 2 years (adjusted for baseline). Secondary outcomes include axial length, best corrected distance visual acuity, near visual acuity, reading speed, pupil diameter, accommodation, adverse event rates and allergic reactions, quality of life (EQ-5D-Y) and tolerability at 2 years. Mechanistic evaluations will include: peripheral axial length, peripheral retinal defocus, anterior chamber depth, iris colour, height and weight, activities questionnaire, ciliary body biometry and chorioretinal thickness. Endpoints from both eyes will be pooled in combined analysis using generalised estimating equations to allow for the correlation between eyes within participant. Three years after cessation of treatment, we will also evaluate refractive error and adverse events.ConclusionsThe Childhood Atropine for Myopia Progression in the UK study will be the first randomised trial reporting outcomes of low-dose atropine eye-drops for children with myopia in a UK population.Trial registration number ISRCTN99883695, NCT03690089.

•Excessive microRNA-328 in the eye is a risk factor for myopia.•An oligonucleotide was designed to neutralize microRNA-328 via eye drops instillation.•No adverse events were found in this trial.•The first-in-human trial demonstrated the novel eye drops was safe and tolerable in children. microRNA-328 has been reported as a risk factor for myopia development. SHJ002 is an antisense for microRNA-328, and SHJ002 was formulated as ophthalmic solution for a novel microRNA therapy. We aimed to investigate the safety and tolerability of SHJ002 ophthalmic solution in children. This was a single-center, open-label, first-in-human trial in healthy children (NCT04928144). All subjects received the study medication. The trial had 2 stages. Stage 1 was an intrasubject dose-escalation study, and stage 2 was the highest tolerable dose study. The SHJ002 ophthalmic solution was instilled in a randomly selected study eye in each participant, whereas the other untreated eye served as a negative control. Three participants were assigned to stage 1, and they received eye drops of 3 concentrations (0.025%, 0.08%, and 0.25%), each of which was used for 3 consecutive days. The highest tolerable dose from stage 1 was used in stage 2 where another 9 participants were recruited for 28-day treatment. Ocular assessments, physical examination, and vital signs were measured to evaluate safety and tolerability. There were 4 boys and 8 girls with a mean age of 12.3 years and a SD of 1.56. All participants were Asians. All 3 concentrations used in stage 1 were well tolerated, and the dose of 0.25% was used in stage 2. There were no reports of discomfort. There was only 1 mild adverse event (punctate keratitis) in the untreated eye in 1 participant, which was deemed as “unrelated to study drug.” SHJ002 is a novel microRNA therapy that uses eye drop instillation. SHJ002 ophthalmic solution is generally safe and tolerable, which warrants further investigations in Phase II and III trials. ClinicalTrials.gov identifier: NCT04928144.

Symptoms and signs of dry eye can significantly increase after cataract surgery. The present study seeks to investigate the effect of intensive lubrication using Systane HYDRATION multi-dose preservative free (MDPF) eye drops (Alcon Research, Ltd., Fort Worth, Texas, USA) on signs and symptoms of dry eye in the postoperative phase. Patients scheduled for cataract surgery were enrolled in this randomised, investigator-masked study and assigned to one of three groups. The risk of developing dry eye was stratified using the ocular surface frailty index (OSFI). The high risk - standard of care (HR-SOC) and treatment (HR-Treatment) group were the high-risk groups (OSFI 0.3 or greater), and the LR-SOC group was the low-risk group (OSFI less than 0.3). HR-SOC and LR-SOC group received the standard postoperative treatment. In the HR-Treatment group, Systane HYDRATION MDPF was added four times a day for three months after surgery. After the baseline examination prior to cataract surgery, three follow up visits were scheduled one week, one month and three months after surgery. OSDI scores, ocular surface staining, and fluorescein break-up time were assessed at each visit. Ninety-five patients were included and 83 entered statistical analyses. OSDI increased in all groups after cataract surgery, and it was lowest in the HR-Treatment group three months after the surgery. In addition, fluorescein break-up time tended to be longer and ocular surface staining less in the HR treatment group at three months. However, there was no statistically significant difference between the groups during the three-month visit. In this randomized, examiner-masked trial no statistically significant difference could be found between the groups, but Systane HYDRATION MDPF may have a positive effect after cataract surgery in high-risk groups for dry eye syndrome. ClinicalTrials.gov NCT06555224.

Human umbilical cord blood (HUCB) serum eye drops contain growth factors, neurotrophic agents, and antimicrobial compounds that may promote ocular surface healing and regeneration. Sjögren's syndrome is a chronic autoimmune condition characterized by reduced tear production and ocular surface damage, often resulting in severe dry eye symptoms. Mustard gas chemical veterans also suffer from similar debilitating ocular complications due to chronic inflammation and meibomian gland dysfunction. While conventional treatments offer symptomatic relief, they lack essential components of natural tears. This pilot randomized controlled trial will evaluate the efficacy of HUCB eye drops in three patient groups: (A) Sjögren's patients treated with HUCB drops, (B) Sjögren's patients receiving conventional treatment, and (C) mustard gas veterans receiving conventional treatment in the right eye and HUCB drops in the left eye. Patients will be assessed using subjective and objective tools, including the Ocular Surface Disease Index (OSDI), visual acuity, tear film breakup time (TBUT), SM tube test, and fluorescein staining based on SICCA criteria. Group allocation will follow a blocked randomization sequence for groups A and B; group C will follow a within-subject paired-eye design. Follow-up will occur at 30 and 60 days. This study aims to assess the regenerative potential of HUCB serum in patients with autoimmune and chemically induced dry eye. Its results may support broader clinical use of HUCB drops in treating severe ocular surface disorders, including conditions like Stevens-Johnson syndrome and industrial chemical exposures. This trial was registered at the Iranian Registry of Clinical Trials (Registration number: IRCT20230925059512N1, Registration date: 2024-08-11).

Dry eye disease (DED) is a common ocular surface disorder. Esculin and digitalis possess anti-inflammatory and anti-oxidant properties, which may benefit patients with DED. This study aimed to assess the therapeutic efficacy of esculin and digitalis glycosides (EAD) eye drops, either alone or in combination with 0.3% sodium hyaluronate (SH) eye drops, in treating DED. In this randomized controlled trial, 78 participants with DED (78 eyes) were included and divided into three groups: Group A received 0.3% SH, Group B received EAD, and Group C received 0.3% SH combined with EAD eye drops for 4 weeks. The efficacy of the treatments was assessed at 2 and 4 weeks using the Ocular Surface Disease Index (OSDI), tear break-up time (TBUT), Schirmer I test (SIt), and corneal fluorescein staining (CFS) as primary evaluation metrics. After 4 weeks of treatment, Group A showed a decrease in OSDI and an increase in SIT ( p  < 0.05). Group B showed a decrease in OSDI score ( P  < 0.05) and a significant improvement in SIt ( P  < 0.01). Group C demonstrated a significant increase in both TBUT and SIt values at the 2-week mark. Improvements were noted across all parameters, including OSDI score, TBUT, SIt, and CFS score after 4 weeks of treatment ( P  < 0.05). The total effective rate for participants in Group C was 88.46%, significantly higher than Group A’s rate of 65.38% ( P  < 0.05). In conclusion, the combination of EAD eye drops with 0.3% SH eye drops proved more effective than either treatment alone.

Myopia has been a rising problem globally. Early-onset myopia significantly increases the risk of high myopia later in life. Despite the proven benefits of increased outdoor time, optimal strategies for preventing early-onset myopia in premyopic children need further investigation. This randomized controlled trial aims to evaluate the efficacy of optical (Defocus Incorporated Multiple Segments [DIMS] spectacle lenses) and pharmacological (0.01% atropine eye drops) interventions in preventing myopia among premyopic preschoolers. We will recruit 234 premyopic, asymptomatic 5-to-6-year-old children who will have received cycloplegic autorefraction examination in a countywide kindergarten eye care program in Yilan County, Taiwan. Eligible participants will be randomly assigned to DIMS spectacles (n = 78), 0.01% atropine (n = 78), or usual care (n = 78). In the DIMS group, preschoolers will be instructed to wear spectacles at home before entering elementary school but to wear them all the time after school entry. In the atropine group, subjects will be given 0.01% atropine eyedrops nightly throughout the study period. All participants will be encouraged to spend time outdoors for 2 hours every day. During the 18-month study period, cycloplegic spherical equivalent (SE) refraction, axial length, and subfoveal choroidal thickness will be measured every three months, and parents-administered questionnaires regarding risk factors for myopia will be performed every nine months. The change in mean cycloplegic SE. The cumulative percentage of incident myopia, the cumulative percentage of a fast myopic shift of SE, and the changes in mean axial length. The time to myopia onset, alteration in subfoveal choroidal thickness, and levels of near work/outdoor activities. This study is registered at www.clinicaltrials.gov as NCT06200194. This trial will provide insights into myopia prevention strategies and inform new eye care policies for early identification and intervention in premyopic preschoolers.

Aims To compare the efficacy and safety of 3% diquafosol ophthalmic solution with those of 0.1% sodium hyaluronate ophthalmic solution in dry eye patients, using mean changes in fluorescein and rose bengal staining scores as endpoints. Trial design and methods In this multicenter, randomised, double-masked, parallel study of 286 dry eye patients with fluorescein and rose bengal staining scores of ≥3 were randomised to the treatment groups in a 1 : 1 ratio. Efficacy and safety were evaluated after drop-wise instillation of the study drug, six times daily for 4 weeks. Results After 4 weeks, the intergroup difference in the mean change from baseline in fluorescein staining score was −0.03; this verified the non-inferiority of diquafosol. The mean change from baseline in rose bengal staining score was significantly lower in the diquafosol group (p=0.010), thus verifying its superiority. The incidence of adverse events was 26.4% and 18.9% in the diquafosol and sodium hyaluronate groups, respectively, with no significant difference. Conclusions Diquafosol (3%) and sodium hyaluronate (0.1%) exhibit similar efficacy in improving fluorescein staining scores of dry eye patients, whereas, diquafosol exhibits superior efficacy in improving rose bengal staining scores. Diquafosol has high clinical efficacy and is well tolerated with a good safety profile.

To compare the efficacy of a 0.15% HA with that of 0.1% HA eye drops for DES after cataract surgery. This study was double blinded, randomized and prospective study, and conducted in 69 participants (70 eyes) from Pusan National University Yangsan Hospital and executed from February 1, 2022 to November 30, 2022. Participants were adult cataract patients with normal lid position, not suffering from any other ocular disease and not meet the exclusion cirteria of clinical trial. Participants were randomly divided into two groups: 35 participants (17 males and 18 females) in the 0.1% HA group and 34 participants (19 males and 15 females) in the 0.15% HA group, receiving treatment six times daily for 6 weeks following cataract surgery. Subjective and objective assessments were performed at preoperative and postoperative visits, including ocular surface disease index score, tear break up time, corneal staining score, Schirmer's I test score, lipid layer thickness), meiboscore, and biochemical analysis of the eye drops. Throughout the study, the postoperative ocular surface disease index score was significantly lower in the group receiving 0.15% hyaluronic acid than in the group receiving 0.1% hyaluronic acid. Additionally, the postoperative ocular surface disease index score showed a significant positive correlation with the postoperative use of 0.15% hyaluronic acid and the preoperative Schirmer's I test score. In multivariate analysis, treatment with 0.15% hyaluronic acid and the preoperative ocular surface disease index score were significant independent parameters affecting the postoperative ocular surface disease index score. The use of 0.15% hyaluronic acid is recommended for its potential advantages in alleviating symptoms following cataract surgery, making it a viable alternative to traditional 0.1% hyaluronic acid treatment. ISRCTN95830348.