NCT06122428|Completed
Efficacy of Riboflavin-Enhanced Hyaluronic Acid Eye Drops in Treating Dry Eye Disease
Modified Sodium Hyaluronate Conjugated to Riboflavin (HAr® 0.1%) as Lubricant Eyedrops in the Treatment of Dry Eye
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Modified Sodium Hyaluronate Conjugated to Riboflavin (HAr® 0.1%) as Lubricant Eyedrops in the Treatment of Dry Eye
Sponsor study identifier
observational
16
1 country
1
Study Start
February 8, 2022
Actual (reported)Primary Completion
July 22, 2022
Actual (reported)Study Completion
October 10, 2022
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 10, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 8, 2022
Actual (reported)July 22, 2022
Actual (reported)October 10, 2022
Actual (reported)October 12, 2023
Actual (reported)November 8, 2023
Actual (reported)Evaluate the efficacy and safety of a new 0.1% sodium hyaluronate-riboflavin-conjugated (HAr®) artificial tear in treating ocular discomfort and improving tear film stability in patients with dry eye disease.
Ocular discomfort reduction mesured by OSDI test.
From enrollment to the end of treatment at 8 weeks
Evaluate the reduction in Tear osmolarity
From enrollment to the end of treatment at 8 weeks
Measure the stability of the tear film
From enrollment to the end of treatment at 8 weeks
Measure the tear production
From enrollment to the end of treatment at 8 weeks
Evaluate corneal staining
From enrollment to the end of treatment at 8 weeks
Composed of 16 eyes (right or left) assigned for the use of modified hyaluronic acid, HAr® 0.1%, covalently linked to Riboflavin
Composed of 16 eyes (right or left) assigned for the use of HA 0.1% alone
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
The study enrolled 16 consecutive patients with bilateral mild to severe Dry Eye Disease (DED) at the University of Naples Federico II, Italy. These participants were selected based on specific eligibility criteria, as outlined in other sections of the study. The selection aimed to ensure that the study population adequately represented individuals experiencing DED.
University of Naples Federico II
Naples, 80131, Italy
Caruso C, D'Andrea L, Rinaldi M, Senese I, Piscopo R, Costagliola C. Modified Sodium hyaluronate conjugated to riboflavin (Har(R) 0.1 %) as lubricant eyedrops in the treatment of dry eye: A prospective randomised study. Heliyon. 2024 Jul 31;10(15):e35527. doi: 10.1016/j.heliyon.2024.e35527. eCollection 2024 Aug 15.
16 participants (actual enrollment reported by the registry).
First Submitted
October 12, 2023
First Posted
November 8, 2023
Study Start
February 8, 2022
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
July 22, 2022
Actual (reported)Study Completion
October 10, 2022
Actual (reported)Last Updated
November 8, 2023
Record last verified: 2023-11
all collected IPD, available on request
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Source: ClinicalTrials.gov.
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