Early Effects of Perfluorohexyloctane Ophthalmic Solution on Patient-Reported Outcomes in Dry Eye Disease: A Prospective, Open-Label, Multicenter Study DOI Creative Commons
Jason Bacharach,

Shane Kannarr,

Anthony Verachtert

et al.

Ophthalmology and Therapy, Journal Year: 2025, Volume and Issue: unknown

Published: Feb. 22, 2025

Perfluorohexyloctane ophthalmic solution (PFHO) is indicated for the treatment of signs and symptoms dry eye disease (DED) targets excessive tear evaporation. This study evaluated patient-reported outcomes early in with PFHO. prospective, multicenter, open-label, phase 4 enrolled adults a history DED ≥ 6 months. PFHO was instilled both eyes four times daily 14 days. Patients completed outcome surveys during clinic visits (day 1 [pretreatment; 5 60 min post-PFHO instillation] days 3, 7, 14). Symptom severity, symptom frequency, satisfaction were rated on visual analog scales (range 0–100). The primary endpoint mean change from baseline overall severity at day 7. Secondary endpoints included individual (eye dryness, blurred vision, irritation, light sensitivity, tiredness, burning/stinging, itching, pain); frequency (measured as percentage time experienced) most bothersome symptom, awareness symptoms, fluctuation quality vision; satisfaction. Ninety-nine patients (85.9% female; age range 35–81 years). met: (SD) decreased significantly 72.1 (17.0) to 27.8 (22.3) 7 (mean change, − 44.5; P < 0.0001). Mean experiencing 77.9% 34.7% (P Significant reductions also observed all postbaseline assessments Median ratings 83.0 86.0 90.0 14. Early course PFHO, experienced significant severity. Treatment high. ClinicalTrials.gov identifier NCT06309953.

Language: Английский

Dry Eye Disease Associated with Meibomian Gland Dysfunction: Focus on Tear Film Characteristics and the Therapeutic Landscape DOI Creative Commons
John D. Sheppard, Kelly K. Nichols

Ophthalmology and Therapy, Journal Year: 2023, Volume and Issue: 12(3), P. 1397 - 1418

Published: March 1, 2023

Meibomian gland dysfunction (MGD) is highly prevalent and the leading cause of evaporative dry eye disease (DED). MGD characterized by a reduction in meibum secretion and/or change composition that results disruption tear film lipid layer an increase evaporation rate. Excessive causes instability, desiccation, hyperosmolarity, inflammation, apoptosis ocular surface cells, resulting continuous cycle DED. The primary treatment goal for DED associated with to restore decrease evaporation, thereby reducing signs symptoms. management includes home care options (eyelid hygiene, warming masks, lubricants) office-based treatments (manual expression, microblepharoexfoliation, thermal pulsation, intense pulsed light, intraductal probing). Topical ophthalmic prescription medications attempt alter various factors may contribute (e.g., bacterial growth, inadequate production). In this review, clinical evidence regarding available emerging therapies from randomized studies patients summarized. Although some modalities have been evaluated specifically MGD, large-scale controlled trials are needed confirm efficacy safety patient population. Currently, there no approved pharmacologic indicated those do not target key driver (i.e., excessive evaporation). NOV03 (perfluorohexyloctane; under review US Food Drug Administration) most advanced therapy has demonstrated statistically significant improvements both symptoms trials. Development novel pharmacotherapies will improve therapeutic allow more individualized approach MGD.

Language: Английский

Citations

63

Overview of Recent Advances in Nano-Based Ocular Drug Delivery DOI Open Access

L Liu,

Yi‐Hao Chen, Da‐Wen Lu

et al.

International Journal of Molecular Sciences, Journal Year: 2023, Volume and Issue: 24(20), P. 15352 - 15352

Published: Oct. 19, 2023

Ocular diseases profoundly impact patients’ vision and overall quality of life globally. However, effective ocular drug delivery presents formidable challenges within clinical pharmacology biomaterial science, primarily due to the intricate anatomical physiological barriers unique eye. In this comprehensive review, we aim shed light on features eye, emphasizing natural it administration. Our goal is provide a thorough overview various characteristics inherent each nano-based system. These encompass nanomicelles, nanoparticles, nanosuspensions, nanoemulsions, microemulsions, nanofibers, dendrimers, liposomes, niosomes, nanowafers, contact lenses, hydrogels, microneedles, innovative gene therapy approaches employing techniques. We delve into biology methodology these systems, introducing their applications over past decade. Furthermore, discuss advantages illuminated by recent studies. While systems for ophthalmic formulations are gaining increasing attention, further research imperative address potential safety toxicity concerns.

Language: Английский

Citations

43

Nanoceria-Mediated Cyclosporin A Delivery for Dry Eye Disease Management through Modulating Immune–Epithelial Crosstalk DOI
Wenyu Cui, Sheng Chen, Tianyi Hu

et al.

ACS Nano, Journal Year: 2024, Volume and Issue: 18(17), P. 11084 - 11102

Published: April 18, 2024

Dry eye disease (DED) affects a substantial worldwide population with increasing frequency. Current single-targeting DED management is severely hindered by the existence of an oxidative stress–inflammation vicious cycle and complicated intercellular crosstalk within ocular microenvironment. Here, nanozyme-based drop, namely nanoceria loading cyclosporin A (Cs@P/CeO2), developed, which possesses long-term antioxidative anti-inflammatory capacities due to its regenerative activity sustained release (CsA). In vitro studies showed that dual-functional Cs@P/CeO2 not only inhibits cellular reactive oxygen species production, sequentially maintaining mitochondrial integrity, but also downregulates inflammatory processes repolarizes macrophages. Moreover, using flow cytometric single-cell sequencing data, in vivo therapeutic effect was systemically demonstrated, rebalances immune–epithelial communication corneal microenvironment less macrophage polarization, restrained stress, enhanced epithelium regeneration. Collectively, our data proved may provide insights into management.

Language: Английский

Citations

19

Chitosan-Based Nanomaterial as Immune Adjuvant and Delivery Carrier for Vaccines DOI Creative Commons

Xiaochen Gong,

Yuan Gao, Jianhong Shu

et al.

Vaccines, Journal Year: 2022, Volume and Issue: 10(11), P. 1906 - 1906

Published: Nov. 11, 2022

With the support of modern biotechnology, vaccine technology continues to iterate. The safety and efficacy vaccines are some most important areas development in field. As a natural substance, chitosan is widely used numerous fields—such as immune stimulation, drug delivery, wound healing, antibacterial procedures—due its good biocompatibility, low toxicity, biodegradability, adhesion. Chitosan-based nanoparticles (NPs) have attracted extensive attention with respect adjuvants delivery systems due their excellent properties, which can effectively enhance responses. Here, we list classifications mechanisms action adjuvants. At same time, preparation methods chitosan, NPs, mechanism system introduced. applications NPs protein nucleic acid also This paper reviewed latest research progress chitosan-based adjuvant systems.

Language: Английский

Citations

55

A Review on Dry Eye Disease Treatment: Recent Progress, Diagnostics, and Future Perspectives DOI Creative Commons
Himangsu Mondal, Ho‐Joong Kim, Nijaya Mohanto

et al.

Pharmaceutics, Journal Year: 2023, Volume and Issue: 15(3), P. 990 - 990

Published: March 19, 2023

Dry eye disease is a multifactorial disorder of the and tear film with potential damage to ocular surface. Various treatment approaches for this aim alleviate symptoms restore normal ophthalmic environment. The most widely used dosage form drops different drugs 5% bioavailability. use contact lenses deliver increases bioavailability by up 50%. Cyclosporin A hydrophobic drug loaded onto treat dry significant improvement. source vital biomarkers various systemic disorders. Several related have been identified. Contact lens sensing technology has become sufficiently advanced detect specific predict conditions accurately. This review focuses on cyclosporin A-loaded lenses, biosensors disease, possibility integrating sensors in therapeutic lenses.

Language: Английский

Citations

32

Non-aqueous formulations in topical ocular drug delivery – A paradigm shift? DOI Creative Commons
Priyanka Agarwal, Ilva D. Rupenthal

Advanced Drug Delivery Reviews, Journal Year: 2023, Volume and Issue: 198, P. 114867 - 114867

Published: May 11, 2023

Topical eyedrop application is the preferred route for drug delivery to anterior segment tissues; however, challenge of overcoming eye's anatomical and physiological barriers while minimising tissue toxicity has restricted developments in this field. Aqueous vehicles have traditionally been used, which typically require several additives preservatives achieve physiologically compatible sterile eyedrops, elevating their potential. Non-aqueous suggested as efficient alternatives topical they can address many limitations associated with conventional aqueous eyedrops. However, despite obvious advantages, non-aqueous eyedrops remain poorly researched few formulations are currently available market. This review challenges hypothesis that solubility a prerequisite ocular absorption establishes rationale using delivery. Recent advances field detailed future research prospects explored, pointing towards paradigm shift formulation near future.

Language: Английский

Citations

22

Mucoadhesive liposomal delivery system synergizing anti-inflammation and anti-oxidation for enhanced treatment against dry eye disease DOI
Kexin Huang, Rong Guo,

Haoyuan Luo

et al.

Journal of Controlled Release, Journal Year: 2024, Volume and Issue: 368, P. 318 - 328

Published: March 4, 2024

Language: Английский

Citations

15

ROS‐Responsive Microneedle Patches Enable Peri‐Lacrimal Gland Therapeutic Administration for Long‐Acting Therapy of Sjögren's Syndrome‐Related Dry Eye DOI Creative Commons

Jingqing Mu,

Xiangyu Ding,

Yapeng Song

et al.

Advanced Science, Journal Year: 2025, Volume and Issue: unknown

Published: Jan. 10, 2025

Abstract Sjögren's syndrome‐related dry eye (SSDE) is a severe subtype characterized by significant immune cell attacks on the lacrimal gland. However, delivering immunosuppressive drugs to glands for SSDE therapy safely and sustainably poses challenges in clinical practice. Herein, ROS‐responsive microneedle patch with detachable functionality (CE‐MN) developed enable straightforward minimally invasive administration gland area penetrating periocular skin. CE‐MN loaded cyclosporin A anti‐inflammatory drug epigallocatechin gallate, latter also serving as cross‐linker matrix. Poly(N‐isopropylacrylamide‐co‐butylacrylate), temperature‐sensitive polymer utilized fabricate separable layers that allow controlled detachment of base from needle, reducing patient discomfort. capable modulating release responding ROS, facilitating on‐demand release, accumulation Compared traditional drops, facilitated long‐acting delivery more than 48 h, demonstrating potent effects an mouse model scavenging ROS inhibiting proliferation Th1, Th17 cells, macrophages. Overall, this potentially offers novel approach treating other ocular chronic diseases.

Language: Английский

Citations

1

Evidence on the Use of Topical Ciclosporin for Ocular Surface Disease: A Systematic Review and Meta‐Analysis DOI Creative Commons
Ngozi Charity Chidi‐Egboka,

Leo Fan,

M Muddasir Qureshi

et al.

Clinical and Experimental Ophthalmology, Journal Year: 2025, Volume and Issue: unknown

Published: March 8, 2025

To identify evidence on the use of topical CsA for ocular surface diseases (OSD). A literature search was conducted following preferred reporting items systematic reviews and meta-analyses (PRISMA) through June 2023 via Cochrane Central Registries, Clinical Trials Registry, Grey citation searching. Randomised clinical trials (RCTs) in which different concentrations were compared with one another or other therapies included. Risk bias assessed ROB2 standard tool. Meta-analysis considered when data sufficient. The certainty using Grading Recommendations, Assessment, Development Evaluations (GRADE). Five hundred eight-three RCT publication titles identified, 48 OSD RCTs Thirty found significantly better efficacy irrespective dose concentration OSD. effect comparable to artificial tears (AT), vehicle, fluorometholone 0.1%, tacrolimus 0.03% diquafosol 3% only 13 trials. Improved outcomes symptoms (RCTs comprising 1107-patients) signs, including staining (2505-patients) average number goblet cells (138-patients) found. Inconsistency treatment particularly tear film function, evident some Ten judged be at high risk bias. low moderate, downgraded mostly imprecision Topical suggests that may superior AT alternatives

Language: Английский

Citations

1

Cyclodextrin-Containing Hydrogels: A Review of Preparation Method, Drug Delivery, and Degradation Behavior DOI Open Access
Jiayue Liu, Bingren Tian, Yumei Liu

et al.

International Journal of Molecular Sciences, Journal Year: 2021, Volume and Issue: 22(24), P. 13516 - 13516

Published: Dec. 16, 2021

Hydrogels possess porous structures, which are widely applied in the field of materials and biomedicine. As a natural oligosaccharide, cyclodextrin (CD) has shown remarkable application prospects synthesis utilization hydrogels. CD can be incorporated into hydrogels to form chemically or physically cross-linked networks. Furthermore, unique cavity structure makes it an ideal vehicle for delivery active ingredients target tissues. This review describes useful methods prepare CD-containing In addition, potential biomedical applications reviewed. The release degradation process under different conditions discussed. Finally, current challenges future research directions on presented.

Language: Английский

Citations

42