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| Name | Class |
|---|---|
| San Giovanni Addolorata Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CX-HA and CS | Device | Sterile Isotonic ophthalmic solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| TBUT | Tear Breakup Time | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| OSDI | Ocular Surface Disease Index | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Giovanni-Addolorata Hospital | Rome | 00184 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17168872 | Background | 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. | |
| 30958186 | Background | 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. |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| 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. | 0 hours |
| 30397820 | Background | 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. |
| 26771686 | Background | 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. |
| 25938030 | Background | 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. |
| 28197326 | Background | 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. |
| 32964952 | Background | 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. |
| 24915011 | Background | 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. |