Dry Eye Disease (DED)NCT06605365

Cross-linked CMC and Silk Proteins in Eye Disease

An observational study of Dry Eye Disease (DED), run by D&V FARMA srl at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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

Who may be able to join

Subjects affected by dry eye disease

Who cannot join

know allergies to CX-CMC
know allergies to SP

Trial locations and contacts

1 site in 1 country.

Italy1 site

San Giovanni-Addolorata Hospital
Rome, 00184

Other trials in Italy

About this study

Official title: Ophthalmic Solution in Drye Eye Patients

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.

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 groups in NCT06605365
Study group	Role	What they receive
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). 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
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
UV and Blue light absorption
The ability of the solution to absorb UV and blue light will be evaluated via a spectrophotometer. The outcome will be measured in arbitrary units.
Measured: 0 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20211 Sep 2022

First posted20 Sep 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

IDs, dates and publications

ClinicalTrials.gov ID: NCT06605365
Sponsor's protocol ID: COR-TF
Status last verified: Sep 2024
First submitted: 18 Sep 2024
Last updated: 20 Sep 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 17168872
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.
PubMed 30958186
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.
PubMed 30397820
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.
PubMed 26771686
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.
PubMed 25938030
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.
PubMed 28197326
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.
PubMed 32964952
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.
PubMed 24915011

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)
Not yet recruitingEarly Phase 1
a Novel siRNA Eyedrops for DED Treatment
Dry Eye
Active, not recruiting
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Meibomian Gland Dysfunction, Dry Eye Disease
Recruiting
Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution
Dry Eye Disease (DED), Contact Lens Discomfort (CLD)
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

All Dry Eye Disease (DED) trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ophthalmic Solution in Drye Eye Patients
ClinicalTrials.gov ID: NCT06605365
Acronym / sponsor ID: COR-TF
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: 20 Sep 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. 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.

Study design

Observational model: Cohort
Time perspective: Other
Target follow-up: 3 Months
Number of arms: 1

Arm	Type	Receives
CXC-SP	–	Device: CX-HA and CSSubjects affected by dry eye disease are treated with the new ophthalmic solution containing cross-linked CMC (CX-CMC) and Silk Proteins (SP).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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

Key inclusion criteria (1 listed)

Subjects affected by dry eye disease

Key exclusion criteria (2 listed)

know allergies to CX-CMC
know allergies to SP

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	CXC-SP

Primary outcome

TBUT
Time frame: 3 months
Tear Breakup Time

3 secondary outcomes

OSDI
Time frame: 3 months
Wound Healing
Time frame: 30 hours
UV and Blue light absorption
Time frame: 0 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 20 Sep 2024.
Background: PubMed 17168872Padamwar 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.
Background: PubMed 30958186Bobadilla 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.
Background: PubMed 30397820Tran 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.
Background: PubMed 26771686D'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.
Background: PubMed 25938030Lee 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.
Background: PubMed 28197326Song 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.
Background: PubMed 32964952Barabino 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.
Background: PubMed 24915011Beckman KA. Characterization of dry eye disease in diabetic patients versus nondiabetic patients. Cornea. 2014 Aug;33(8):851-4. doi: 10.1097/ICO.0000000000000163.
Individual participant dataSharing planned: No

Related trials for Dry Eye Disease (DED)

Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)
Not yet recruitingEarly Phase 1
a Novel siRNA Eyedrops for DED Treatment
Dry Eye
Active, not recruiting
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Meibomian Gland Dysfunction, Dry Eye Disease
Recruiting
Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution
Dry Eye Disease (DED), Contact Lens Discomfort (CLD)
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

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 20 Sep 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 NCT06605365, 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 20 Sep 2024.