Comparison of the Performance and Safety of T2769 Versus Hylo-Forte® in the Treatment of Moderate to Severe Dry Eye Syndrome.
T2769
+ Hylo-Forte®
Eye Diseases
+ Lacrimal Apparatus Diseases
+ Dry Eye Syndromes
Treatment Study
Summary
Study start date: September 17, 2024
Actual date on which the first participant was enrolled.This study aims to evaluate whether a new eye treatment, called T2769, is as effective and safe as an existing treatment, Hylo-Forte®, for people suffering from moderate to severe dry eye syndrome. Dry eye syndrome is a common condition that can cause discomfort and vision problems. The study is important because finding a treatment that is as good as or better than current options could improve quality of life for many individuals experiencing this condition. Participants in the study will be using either T2769 or Hylo-Forte® to treat their eyes, and the effectiveness will be measured by looking at changes in the eye’s surface using a specific scale. This scale, known as the Oxford 0-15 scale, helps to assess how much the eye has improved over time. The study will compare the results from the beginning of the trial to the results observed on day 36. Since this is a late-stage study, it focuses on confirming the safety and performance of the T2769 treatment in a real-world setting.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.74 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 4 locations
Axon Clinical, s.r.o.
Prague, CzechiaGanglion Medical Center
Pécs, HungaryErmellek Egeszsegcentrum
Létavértes, Hungary