Dry Eye DiseaseNCT06122428
Efficacy of Riboflavin-Enhanced Hyaluronic Acid Eye Drops in Treating Dry Eye Disease
An observational study of Dry Eye Disease, run by University of Naples at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- modified hyaluronic acid 0.1% covalently linked to Riboflavin and hyaluronic acid 0.1%
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- 8 Feb 2022to 10 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
None listed.
Who cannot join
- Age below 18 years
- Severe ocular surface affections
- Unilateral dry eye syndrome
- Refractive surgery performed within the last six months
- Eye surgery performed within the last three months
- Previous herpetic keratitis
Show all 10Show fewer
- Signs of active corneal infection
- Systemic or topical steroid therapy within the last 30 days
- Topical therapy within the last 14 days
- Inability to understand the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modified Sodium Hyaluronate Conjugated to Riboflavin (HAr® 0.1%) as Lubricant Eyedrops in the Treatment of Dry Eye
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:
Read more
- 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.
Read the detailed description
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:
- Group X: received Riboflavin-Enhanced Hyaluronic Acid Eye Drops (HAr® 0.1%) (Ribohyal Group).
- Group Y: received standard HA 0.1% eye drops (Control Group).
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.
- Conditions
- Dry Eye Disease
- Being tested
- modified hyaluronic acid 0.1% covalently linked to Riboflavin, hyaluronic acid 0.1%
- Keywords
- dry eye disease, ribohyal, ocular surface, tear check
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified hyaluronic acid 0.1% covalently linked to RiboflavinDrug
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
hyaluronic acid 0.1%Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Group X: Ribohyal Group | Composed of 16 eyes (right or left) assigned for the use of modified hyaluronic acid, HAr® 0.1%, covalently linked to Riboflavin Receives: Drug: modified hyaluronic acid 0.1% covalently linked to Riboflavin | |
| Group Y: (Control Group) | Composed of 16 eyes (right or left) assigned for the use of HA 0.1% alone Receives: Drug: hyaluronic acid 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (4)
Evaluate the reduction in Tear osmolarity
Tear osmolarity test. This measurement provides important information about tear composition.
Measured: From enrollment to the end of treatment at 8 weeks
Measure the stability of the tear film
Tear Break-Up Time (TBUT) test This measures the stability of the tear film.
Measured: From enrollment to the end of treatment at 8 weeks
Measure the tear production
Schirmer test I (without anesthetic) at 5 minutes. This measures tear production.
Measured: From enrollment to the end of treatment at 8 weeks
Evaluate corneal staining
Biomicroscopic observation with white light and cobalt blue light according to the Oxford scheme. It provides information on corneal health.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start8 Feb 2022
- Primary completion22 Jul 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca D'Andrea, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122428
- Sponsor's protocol ID
- CIT_001
- Status last verified
- Nov 2023
- First submitted
- 12 Oct 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, available on request
Publications
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.
PubMed 39170271
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Sodium Hyaluronate Conjugated to Riboflavin (HAr® 0.1%) as Lubricant Eyedrops in the Treatment of Dry Eye
- ClinicalTrials.gov ID
- NCT06122428
- Acronym / sponsor ID
- CIT_001
- Conditions
- Dry Eye Disease
- Keywords
- dry eye disease, ribohyal, ocular surface, tear check
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of NaplesUniversity, hospital or other
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Group X: received Riboflavin-Enhanced Hyaluronic Acid Eye Drops (HAr® 0.1%) (Ribohyal Group).
- Group Y: received standard HA 0.1% eye drops (Control Group).
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group X: Ribohyal Group | – | Drug: modified hyaluronic acid 0.1% covalently linked to RiboflavinComposed of 16 eyes (right or left) assigned for the use of modified hyaluronic acid, HAr® 0.1%, covalently linked to Riboflavin |
| Group Y: (Control Group) | – | Drug: hyaluronic acid 0.1%Composed of 16 eyes (right or left) assigned for the use of HA 0.1% alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Age below 18 years
- Severe ocular surface affections
- Unilateral dry eye syndrome
- Refractive surgery performed within the last six months
- Eye surgery performed within the last three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modified hyaluronic acid 0.1% covalently linked to RiboflavinThe 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 | Drug | Group X: Ribohyal Group |
| hyaluronic acid 0.1%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 | Drug | Group Y: (Control Group) |
Primary outcome
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.
Time frame: From enrollment to the end of treatment at 8 weeks
Ocular discomfort reduction mesured by OSDI test.
4 secondary outcomes
Evaluate the reduction in Tear osmolarity
Time frame: From enrollment to the end of treatment at 8 weeks
Measure the stability of the tear film
Time frame: From enrollment to the end of treatment at 8 weeks
Measure the tear production
Time frame: From enrollment to the end of treatment at 8 weeks
Evaluate corneal staining
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Derived from this study: PubMed 39170271Caruso 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.
- Individual participant dataSharing planned: Yes. all collected IPD, available on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye Disease, run by University of Naples at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06122428, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.