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Efficacy, Safety, and Tolerability of a Novel Cyclosporine, a Formulation for Dry Eye Disease: A Multicenter Phase II Clinical Study.

Author: ChenRong-Xin, DaiHong, GaoZi-Qing, LiXiao-Yi, LiYing, PengWen-Yan, ZhouShi-You, ZhuLei

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Overview

This Phase II clinical trial investigated the efficacy, safety, and tolerability of a novel cyclosporine formulation (CyclAGel) for dry eye disease (DED). CyclAGel showed consistent improvement in eye dryness score, symptoms of dryness, corneal fluorescein staining, breakup time, and Schirmer test scores compared to Restasis. While CyclAGel showed promising results, no statistically significant differences were found between CyclAGel and Restasis after baseline corrections. Further research with longer follow-up is needed to confirm these findings.
Paper Details　
Original Abstract of the Article :
PURPOSE: The purpose of this study was to explore the efficacy, safety, and tolerability of a novel cyclosporine formulation for dry eye disease (DED). METHODS: This is an exploratory, multicenter, single-blind, randomized, positive-controlled Phase II clinical trial between cyclosporine ophthalmic...See full text at original site
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引用元：
https://doi.org/10.1016/j.clinthera.2020.12.023

データ提供：米国国立医学図書館（NLM）

Cyclosporine Ophthalmic Gel: A Cool Oasis in the Desert of Dry Eye Disease

The relentless desert of dry eye disease (DED) can leave individuals feeling parched and uncomfortable. This research, like a dedicated explorer seeking a source of relief, investigates the efficacy, safety, and tolerability of a novel cyclosporine formulation for dry eye disease. The researchers conducted a multicenter, randomized, positive-controlled Phase II clinical trial, meticulously comparing the effects of this new cyclosporine ophthalmic gel (CyclAGel) to a widely used comparator, Restasis.

A Refreshing Solution: Cyclosporine Ophthalmic Gel Offers Hope

The study found that CyclAGel showed consistent improvement in eye dryness score and other dryness symptoms compared to Restasis. While no statistically significant differences were observed between the two treatments after baseline corrections, CyclAGel demonstrated a better effect in each of the treated groups. It's like finding a cool spring in the desert, offering a refreshing and potentially healing solution to a common ailment.

Navigating the Desert of Dry Eye Disease

This research provides valuable insights into the potential of CyclAGel as a treatment option for dry eye disease (DED). The study's findings suggest that this novel cyclosporine formulation may offer a safe and tolerable alternative to existing treatments. It's a reminder that in the vast desert of dry eye disease, we must continue to explore innovative approaches to alleviate discomfort and improve patient well-being.

Dr. Camel's Conclusion

This study provides valuable insights into the potential of cyclosporine ophthalmic gel (CyclAGel) as a treatment option for dry eye disease (DED). While further research is needed to confirm its efficacy, the study's findings suggest that this novel formulation may offer a safe, tolerable, and potentially more effective alternative to existing treatments. It's a reminder that in the vast desert of medical advancements, we must continue to explore innovative approaches to address the challenges of common ailments and improve patient comfort.

Date :
  1. Date Completed 2021-10-15
  2. Date Revised 2021-10-15
Further Info :

Pubmed ID

33546885

DOI: Digital Object Identifier

10.1016/j.clinthera.2020.12.023

Related Literature

Article Analysis
・Effects of cyclosporine ophthalmic
SNS
PICO Info
in preparation
Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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