Dry Eye Disease (DED)NCT06573606
Ophthalmic Solution in Diabetic Corneal Alteration
An observational study of Dry Eye Disease (DED), run by D&V FARMA srl at 1 site in Italy.
Trial summary
Data analyses and revision of the DED symptoms in diabetic subjects. A novel ophthalmic solution containing cross-linked ha (CX-HA) and Chondroitin sulphate (CS) has been made available on the market. Both molecules have been widely studied for their viscoelastic and hydrating properties. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease (DED)
- What is being tested?
- CX-HA and CS
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2021to 1 Sep 2022
- How long will I take part?
- 3 Months
- 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: Data derived from diabetic subject affected by dry eye disease and treated with the ophthalmic solution containing CX-HA and CS will be collected and analysed
Who may be able to join
- Diabetic Subjects affected by dry eye disease
Who cannot join
- know allergies to CX-HA
- know allergies to CS
Trial locations and contacts
1 site in 1 country.
About this study
Data analyses and revision of the DED symptoms in diabetic subjects. A novel ophthalmic solution containing cross-linked ha (CX-HA) and Chondroitin sulphate (CS) has been made available on the market.
Both molecules have been widely studied for their viscoelastic and hydrating properties.
Nevertheless, the use of CS in ophthalmology has been limited since, routinely, the molecule is of animal origins.
This new ophthalmic solution is the first on the market formulated with a CS of non-animal origin.
- Conditions
- Dry Eye Disease (DED)
- Being tested
- CX-HA and CS
- 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.
CX-HA and CSDevice
Sterile Isotonic ophthalmic solution
| Study group | Role | What they receive |
|---|---|---|
| HA-CS | Diabetic subjects affected by dry eye disease are treated with the new ophthalmic solution containing cross-linked hyaluronic acid (CX-HA) and Chondroitin sulphate (CS). Receives: Device: CX-HA and CS |
What is being measured
The primary outcome is the main question the study is designed to answer.
TBUT
Tear Breakup Time
Measured: 3 months
Secondary outcomes (3)
OSDI
Ocular Surface Disease Index
Measured: 3 months
Corneal Sensitivity
measured via the "Luneau Cochet-Bonnet Aesthesiometer", results are expressed in cm
Measured: 3 months
Wound Healing
Scratch test performed on cell lines using the "Ibidi Culture-Inserts". The test provides hinds on the ability of a cell line to cover a "wound" created in the monolayer. Results are given as % of the area covered
Measured: 30 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start1 Sep 2021
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Dry Eye Disease (DED)Studies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 20 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- D&V FARMA srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- San Giovanni Addolorata Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573606
- Sponsor's protocol ID
- DIDI01
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zou X, Lu L, Xu Y, Zhu J, He J, Zhang B, Zou H. Prevalence and clinical characteristics of dry eye disease in community-based type 2 diabetic patients: the Beixinjing eye study. BMC Ophthalmol. 2018 May 10;18(1):117. doi: 10.1186/s12886-018-0781-7.
PubMed 29747621Guerrero-Moreno A, Baudouin C, Melik Parsadaniantz S, Reaux-Le Goazigo A. Morphological and Functional Changes of Corneal Nerves and Their Contribution to Peripheral and Central Sensory Abnormalities. Front Cell Neurosci. 2020 Dec 10;14:610342. doi: 10.3389/fncel.2020.610342. eCollection 2020.
PubMed 33362474Yoo TK, Oh E. Diabetes mellitus is associated with dry eye syndrome: a meta-analysis. Int Ophthalmol. 2019 Nov;39(11):2611-2620. doi: 10.1007/s10792-019-01110-y. Epub 2019 May 7.
PubMed 31065905Posarelli C, Passani A, Del Re M, Fogli S, Toro MD, Ferreras A, Figus M. Cross-Linked Hyaluronic Acid as Tear Film Substitute. J Ocul Pharmacol Ther. 2019 Sep;35(7):381-387. doi: 10.1089/jop.2018.0151. Epub 2019 Aug 2.
PubMed 31373862Ledbetter EC, Munger RJ, Ring RD, Scarlett JM. Efficacy of two chondroitin sulfate ophthalmic solutions in the therapy of spontaneous chronic corneal epithelial defects and ulcerative keratitis associated with bullous keratopathy in dogs. Vet Ophthalmol. 2006 Mar-Apr;9(2):77-87. doi: 10.1111/j.1463-5224.2006.00439.x.
PubMed 16497231Postorino EI, Rania L, Aragona E, Mannucci C, Alibrandi A, Calapai G, Puzzolo D, Aragona P. Efficacy of eyedrops containing cross-linked hyaluronic acid and coenzyme Q10 in treating patients with mild to moderate dry eye. Eur J Ophthalmol. 2018 Jan;28(1):25-31. doi: 10.5301/ejo.5001011. Epub 2018 Feb 19.
PubMed 28777385Carlson E, Kao WWY, Ogundele A. Impact of Hyaluronic Acid-Containing Artificial Tear Products on Reepithelialization in an In Vivo Corneal Wound Model. J Ocul Pharmacol Ther. 2018 May;34(4):360-364. doi: 10.1089/jop.2017.0080. Epub 2018 Feb 2.
PubMed 29394128Scarinci F, De Simone G, Ciancimino C, Caggiano C, Pocobelli G, Di Masi A. Enhancing Corneal Sensitivity in Diabetic Patients Through an Innovative Ophthalmic Solution: In Vivo and Vitro Results. J Clin Med. 2025 Jan 3;14(1):245. doi: 10.3390/jcm14010245.
PubMed 39797325
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ophthalmic Solution in Diabetic Corneal Alteration
- ClinicalTrials.gov ID
- NCT06573606
- Acronym / sponsor ID
- DIDI01
- Conditions
- Dry Eye Disease (DED)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- D&V FARMA srlIndustry (pharma, biotech, devices)
- Collaborators
- San Giovanni Addolorata Hospital
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 27 Aug 2024 (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.
Data analyses and revision of the DED symptoms in diabetic subjects. A novel ophthalmic solution containing cross-linked ha (CX-HA) and Chondroitin sulphate (CS) has been made available on the market.
Both molecules have been widely studied for their viscoelastic and hydrating properties.
Nevertheless, the use of CS in ophthalmology has been limited since, routinely, the molecule is of animal origins.
This new ophthalmic solution is the first on the market formulated with a CS of non-animal origin.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HA-CS | – | Device: CX-HA and CSDiabetic subjects affected by dry eye disease are treated with the new ophthalmic solution containing cross-linked hyaluronic acid (CX-HA) and Chondroitin sulphate (CS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data derived from diabetic subject affected by dry eye disease and treated with the ophthalmic solution containing CX-HA and CS will be collected and analysed
Key inclusion criteria (1 listed)
- Diabetic Subjects affected by dry eye disease
Key exclusion criteria (2 listed)
- know allergies to CX-HA
- know allergies to CS
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 |
|---|---|---|
| CX-HA and CSSterile Isotonic ophthalmic solution | Device | HA-CS |
Primary outcome
TBUT
Time frame: 3 months
Tear Breakup Time
3 secondary outcomes
OSDI
Time frame: 3 months
Corneal Sensitivity
Time frame: 3 months
Wound Healing
Time frame: 30 hours
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 29 Aug 2024.
- Background: PubMed 29747621Zou X, Lu L, Xu Y, Zhu J, He J, Zhang B, Zou H. Prevalence and clinical characteristics of dry eye disease in community-based type 2 diabetic patients: the Beixinjing eye study. BMC Ophthalmol. 2018 May 10;18(1):117. doi: 10.1186/s12886-018-0781-7.
- Background: PubMed 33362474Guerrero-Moreno A, Baudouin C, Melik Parsadaniantz S, Reaux-Le Goazigo A. Morphological and Functional Changes of Corneal Nerves and Their Contribution to Peripheral and Central Sensory Abnormalities. Front Cell Neurosci. 2020 Dec 10;14:610342. doi: 10.3389/fncel.2020.610342. eCollection 2020.
- Background: PubMed 31065905Yoo TK, Oh E. Diabetes mellitus is associated with dry eye syndrome: a meta-analysis. Int Ophthalmol. 2019 Nov;39(11):2611-2620. doi: 10.1007/s10792-019-01110-y. Epub 2019 May 7.
- Background: PubMed 31373862Posarelli C, Passani A, Del Re M, Fogli S, Toro MD, Ferreras A, Figus M. Cross-Linked Hyaluronic Acid as Tear Film Substitute. J Ocul Pharmacol Ther. 2019 Sep;35(7):381-387. doi: 10.1089/jop.2018.0151. Epub 2019 Aug 2.
- Background: PubMed 16497231Ledbetter EC, Munger RJ, Ring RD, Scarlett JM. Efficacy of two chondroitin sulfate ophthalmic solutions in the therapy of spontaneous chronic corneal epithelial defects and ulcerative keratitis associated with bullous keratopathy in dogs. Vet Ophthalmol. 2006 Mar-Apr;9(2):77-87. doi: 10.1111/j.1463-5224.2006.00439.x.
- Background: PubMed 28777385Postorino EI, Rania L, Aragona E, Mannucci C, Alibrandi A, Calapai G, Puzzolo D, Aragona P. Efficacy of eyedrops containing cross-linked hyaluronic acid and coenzyme Q10 in treating patients with mild to moderate dry eye. Eur J Ophthalmol. 2018 Jan;28(1):25-31. doi: 10.5301/ejo.5001011. Epub 2018 Feb 19.
- Background: PubMed 29394128Carlson E, Kao WWY, Ogundele A. Impact of Hyaluronic Acid-Containing Artificial Tear Products on Reepithelialization in an In Vivo Corneal Wound Model. J Ocul Pharmacol Ther. 2018 May;34(4):360-364. doi: 10.1089/jop.2017.0080. Epub 2018 Feb 2.
- Derived from this study: PubMed 39797325Scarinci F, De Simone G, Ciancimino C, Caggiano C, Pocobelli G, Di Masi A. Enhancing Corneal Sensitivity in Diabetic Patients Through an Innovative Ophthalmic Solution: In Vivo and Vitro Results. J Clin Med. 2025 Jan 3;14(1):245. doi: 10.3390/jcm14010245.
- Individual participant dataSharing planned: No
Related trials for Dry Eye Disease (DED)
Not yet recruitingPhase 1
A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
Keratitis, Autoimmunity
Recruiting
Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution
Dry Eye Disease (DED), Contact Lens Discomfort (CLD)
Active, not recruitingPhase 2/3
A Clinical Study Evaluating Licaminlimab for Dry Eye Disease
Dry Eye Disease (DED)
RecruitingPhase 2
An Exploratory Efficacy and Safety Study of DFL24498 Topical Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease
Dry Eye Disease (DED)
Recruiting
Upper Punctal Plug Occlusion in Previous Lower Punctal Occlusion.
DED, Aqueous-deficient Dry Eye Disease
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 (DED), run by D&V FARMA srl 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 1 inclusion and 2 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 29 Aug 2024. 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?
TBUT (time frame: 3 months). 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 NCT06573606, which also lists 8 linked publications.
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 29 Aug 2024.