NCT06605365

Brief Summary

Data analyses and revision of the DED symptoms. A novel ophthalmic solution containing cross-linked CMC (CX-CMC) and Silk Proteins (SP) has been made available on the market. Both molecules have been widely studied for their viscoelastic and hydrating, and wound healing properties. This new ophthalmic solution is the first on the market formulated with a CX-CMC and SP.

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

September 18, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2024

Completed
Last Updated

September 20, 2024

Status Verified

September 1, 2024

Enrollment Period

1 year

First QC Date

September 18, 2024

Last Update Submit

September 18, 2024

Conditions

Dry Eye Disease (DED)

Outcome Measures

Primary Outcomes (1)

  • TBUT

    Tear Breakup Time

    3 months

Secondary Outcomes (3)

  • OSDI

    3 months

  • Wound Healing

    30 hours

  • UV and Blue light absorption

    0 hours

Study Arms (1)

CXC-SP

Subjects affected by dry eye disease are treated with the new ophthalmic solution containing cross-linked CMC (CX-CMC) and Silk Proteins (SP).

Device: CX-HA and CS

Interventions

CX-HA and CSDEVICE

Sterile Isotonic ophthalmic solution

CXC-SP

Eligibility Criteria

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

Data derived from subject affected by dry eye disease and treated with the ophthalmic solution containing CX-CMC and SP will be collected and analysed

You may qualify if:

  • Subjects affected by dry eye disease

You may not qualify if:

  • know allergies to CX-CMC
  • know allergies to SP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Giovanni-Addolorata Hospital

Rome, 00184, Italy

Location

Related Publications (8)

  • Padamwar MN, Pawar AP, Daithankar AV, Mahadik KR. Silk sericin as a moisturizer: an in vivo study. J Cosmet Dermatol. 2005 Dec;4(4):250-7. doi: 10.1111/j.1473-2165.2005.00200.x.

    PMID: 17168872BACKGROUND

  • Bobadilla AVP, Arevalo J, Sarro E, Byrne HM, Maini PK, Carraro T, Balocco S, Meseguer A, Alarcon T. In vitro cell migration quantification method for scratch assays. J R Soc Interface. 2019 Feb 28;16(151):20180709. doi: 10.1098/rsif.2018.0709.

    PMID: 30958186BACKGROUND

  • Tran SH, Wilson CG, Seib FP. A Review of the Emerging Role of Silk for the Treatment of the Eye. Pharm Res. 2018 Nov 5;35(12):248. doi: 10.1007/s11095-018-2534-y.

    PMID: 30397820BACKGROUND

  • D'Aloiso MC, Senzolo M, Azzena B. Efficacy and Safety of Cross-Linked Carboxymethylcellulose Filler for Rejuvenation of the Lower Face: A 6-Month Prospective Open-Label Study. Dermatol Surg. 2016 Feb;42(2):209-17. doi: 10.1097/DSS.0000000000000592.

    PMID: 26771686BACKGROUND

  • Lee JS, Lee SU, Che CY, Lee JE. Comparison of cytotoxicity and wound healing effect of carboxymethylcellulose and hyaluronic acid on human corneal epithelial cells. Int J Ophthalmol. 2015 Apr 18;8(2):215-21. doi: 10.3980/j.issn.2222-3959.2015.02.01. eCollection 2015.

    PMID: 25938030BACKGROUND

  • Song JK, Lee K, Park HY, Hyon JY, Oh SW, Bae WK, Han JS, Jung SY, Um YJ, Lee GH, Yang JH. Efficacy of Carboxymethylcellulose and Hyaluronate in Dry Eye Disease: A Systematic Review and Meta-Analysis. Korean J Fam Med. 2017 Jan;38(1):2-7. doi: 10.4082/kjfm.2017.38.1.2. Epub 2017 Jan 18.

    PMID: 28197326BACKGROUND

  • Barabino S, Benitez-Del-Castillo JM, Fuchsluger T, Labetoulle M, Malachkova N, Meloni M, Utheim TP, Rolando M. Dry eye disease treatment: the role of tear substitutes, their future, and an updated classification. Eur Rev Med Pharmacol Sci. 2020 Sep;24(17):8642-8652. doi: 10.26355/eurrev_202009_22801.

    PMID: 32964952BACKGROUND

  • Beckman KA. Characterization of dry eye disease in diabetic patients versus nondiabetic patients. Cornea. 2014 Aug;33(8):851-4. doi: 10.1097/ICO.0000000000000163.

    PMID: 24915011BACKGROUND

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

September 18, 2024

First Posted

September 20, 2024

Study Start

September 1, 2021

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

September 20, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)