University of Naples Federico II
Naples, 80131, Italy
NCT Number: NCT06122428
The goal of this retrospective study is to evaluate the historical effectiveness of Riboflavin-Enhanced Hyaluronic Acid Eye Drops (HAr® 0.1%) in the treatment of Dry Eye Disease (DED) among patients. The product under investigation, Ribohyal®, had previously obtained certification and authorization from the relevant notified body for market sale (European patent n. 2228058)
The primary questions it aimed to address were:
* Did the use of Riboflavin-Enhanced Hyaluronic Acid Eye Drops result in a reduction of dry eye symptoms and an improvement in ocular comfort among patients with DED in a historical context? * Was Riboflavin-Enhanced Hyaluronic Acid Eye Drops historically more effective in reducing photophobia and enhancing tear film stability when compared to standard treatment?
Participants in this retrospective analysis had historically:
* Used either Riboflavin-Enhanced Hyaluronic Acid Eye Drops or a standard hyaluronic acid eye drop, based on their assigned group. * Historically reported their levels of ocular discomfort and photophobia at specified time points. * Undergone historical clinical examinations to assess tear film stability and osmolarity.
Researchers conducted a retrospective analysis to compare the historical outcomes of the group using Riboflavin-Enhanced Hyaluronic Acid Eye Drops with the group using standard eye drops to determine if the former historically provided more significant improvements in dry eye symptoms and tear film stability.
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Notify Me18 year and older
All sexes
Observational
Naples, 80131, Italy
In this retrospective study, the investigators have examined the historical therapeutic efficacy of Riboflavin-Enhanced Hyaluronic Acid Eye Drops (HAr® 0.1%) in the treatment of Dry Eye Disease (DED), adhering to good clinical practice principles.
Participants were historically divided into two groups:
The historical outcome measures included the retrospective assessments of osmolarity, Tear Break-Up Time (TBUT), corneal staining, Schirmer test, tear meniscus measurement, and Non-invasive Break-Up Time (NIBUT). The Ocular Surface Disease Index (OSDI) score was historically recorded at various time points.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for patient selection included a dry eye history of at least three months, OSDI score ≥ 23, and positivity in at least one eye for one or more of the following diagnostic criteria:
Exclusion criteria
The patients used the eye drops no less than 3 times a day or no more than 6 times a day, according to their needs. They reported the instillation frequency (3/4 or 5/6 times per day) on the provided document
The patients used the eye drops no less than 3 times a day or no more than 6 times a day, according to their needs. They reported the instillation frequency (3/4 or 5/6 times per day) on the provided document
Time frame: From enrollment to the end of treatment at 8 weeks
Ocular discomfort reduction mesured by OSDI test.
Time frame: From enrollment to the end of treatment at 8 weeks
Tear osmolarity test. This measurement provides important information about tear composition.
Time frame: From enrollment to the end of treatment at 8 weeks
Tear Break-Up Time (TBUT) test This measures the stability of the tear film.
Time frame: From enrollment to the end of treatment at 8 weeks
Schirmer test I (without anesthetic) at 5 minutes. This measures tear production.
Time frame: From enrollment to the end of treatment at 8 weeks
Biomicroscopic observation with white light and cobalt blue light according to the Oxford scheme. It provides information on corneal health.
University of Naples
Other
Modified Sodium Hyaluronate Conjugated to Riboflavin (HAr® 0.1%) as Lubricant Eyedrops in the Treatment of Dry Eye
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