NCT06573606

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 27, 2024

Completed
Last Updated

August 29, 2024

Status Verified

August 1, 2024

Enrollment Period

1 year

First QC Date

August 21, 2024

Last Update Submit

August 27, 2024

Conditions

Dry Eye Disease (DED)

Outcome Measures

Primary Outcomes (1)

  • TBUT

    Tear Breakup Time

    3 months

Secondary Outcomes (3)

  • OSDI

    3 months

  • Corneal Sensitivity

    3 months

  • Wound Healing

    30 hours

Study Arms (1)

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).

Device: CX-HA and CS

Interventions

CX-HA and CSDEVICE

Sterile Isotonic ophthalmic solution

HA-CS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Diabetic Subjects affected by dry eye disease

You may not qualify if:

  • know allergies to CX-HA
  • know allergies to CS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Giovanni-Addolorata Hospital

Rome, 00184, Italy

Location

Related Publications (8)

  • 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.

    PMID: 29747621BACKGROUND

  • Guerrero-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.

    PMID: 33362474BACKGROUND

  • Yoo 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.

    PMID: 31065905BACKGROUND

  • Posarelli 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.

    PMID: 31373862BACKGROUND

  • Ledbetter 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.

    PMID: 16497231BACKGROUND

  • Postorino 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.

    PMID: 28777385BACKGROUND

  • Carlson 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.

    PMID: 29394128BACKGROUND

  • Scarinci 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.

    PMID: 39797325DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
3 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2024

First Posted

August 27, 2024

Study Start

September 1, 2021

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

August 29, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)