Crosslinked Hyaluronic Acid With Liposomes and Crocin in Dry Eye
1 other identifier
interventional
25
1 country
1
Brief Summary
A total of 50 eyes were analyzed (25 patients). The subjects selected were over 18 years of age. No gender distinction was made in the choice of subjects. All subjects were carriers of silicone hydrogel contact lenses. The antecedents of the eye diseases not identified, neither the previous eye surgeries nor the systemic or ocular medication. All patients read, understood and signed an informed consent form of the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2017
Shorter than P25 for not_applicable
1 active site
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
October 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2018
CompletedFirst Submitted
Initial submission to the registry
July 16, 2018
CompletedFirst Posted
Study publicly available on registry
August 6, 2018
CompletedAugust 14, 2018
August 1, 2018
4 months
July 16, 2018
August 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Schirmer Test
Measurement of the tear volume. Scale between 0 and 30 milimeters (mm) Higger is better
6 weeks
Break Up Time Test
Lacrimal rupture time of the lipid layer. Scale between 0 and 25 seconds (s) Higger is better
6 weeks
Ocular Surface Disease Index
Dry Eye Score from Questionnaire. Scale between 0 and 50 points. Higger is worse
6 weeks
Study Arms (2)
Hyaluronic Acid
EXPERIMENTALOne drop application of Hyaluronic acid + Galact-Xyloglucan with a dosage of 3 times a day for 45 days
CrossLinked Hyalurnic Acid
EXPERIMENTALOne drop application of Crosslinked Hylauronic Acid + Liposomes with a dosage of 3 times a day for 45 days
Interventions
Schirmer Test, BUT test and OSDI test. Previous and After treatment
Eligibility Criteria
You may qualify if:
- Ocular Surface Disease Index over 15
- Dysfunction of the meibomian gland
- User contact lenses silicone hydrogel
- User of digital screens for a long timeç
You may not qualify if:
- Previous eye surgeries
- Previous eye pathologies
- User of artificial tears
- User of ophthalmic gels
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
José-María Sánchez-González
Seville, Seville, 41012, Spain
Related Publications (8)
Fallacara A, Vertuani S, Panozzo G, Pecorelli A, Valacchi G, Manfredini S. Novel Artificial Tears Containing Cross-Linked Hyaluronic Acid: An In Vitro Re-Epithelialization Study. Molecules. 2017 Nov 30;22(12):2104. doi: 10.3390/molecules22122104.
PMID: 29189737RESULTUccello-Barretta G, Balzano F, Vanni L, Sanso M. Mucoadhesive properties of tamarind-seed polysaccharide/hyaluronic acid mixtures: A nuclear magnetic resonance spectroscopy investigation. Carbohydr Polym. 2013 Jan 16;91(2):568-72. doi: 10.1016/j.carbpol.2012.07.085. Epub 2012 Aug 25.
PMID: 23121946RESULTDoan S, Bremond-Gignac D, Chiambaretta F. Comparison of the effect of a hyaluronate-trehalose solution to hyaluronate alone on Ocular Surface Disease Index in patients with moderate to severe dry eye disease. Curr Med Res Opin. 2018 Aug;34(8):1373-1376. doi: 10.1080/03007995.2018.1434496. Epub 2018 Feb 7.
PMID: 29381080RESULTJacobi C, Kruse FE, Cursiefen C. Prospective, randomized, controlled comparison of SYSTANE UD eye drops versus VISINE INTENSIV 1% EDO eye drops for the treatment of moderate dry eye. J Ocul Pharmacol Ther. 2012 Dec;28(6):598-603. doi: 10.1089/jop.2012.0066. Epub 2012 Jul 19.
PMID: 22813209RESULTPostorino 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: 28777385RESULTAcar D, Molina-Martinez IT, Gomez-Ballesteros M, Guzman-Navarro M, Benitez-Del-Castillo JM, Herrero-Vanrell R. Novel liposome-based and in situ gelling artificial tear formulation for dry eye disease treatment. Cont Lens Anterior Eye. 2018 Feb;41(1):93-96. doi: 10.1016/j.clae.2017.11.004. Epub 2017 Dec 6.
PMID: 29223649RESULTRolando M, Valente C. Establishing the tolerability and performance of tamarind seed polysaccharide (TSP) in treating dry eye syndrome: results of a clinical study. BMC Ophthalmol. 2007 Mar 29;7:5. doi: 10.1186/1471-2415-7-5.
PMID: 17394642RESULTWilliams DL, Mann BK. Efficacy of a crosslinked hyaluronic acid-based hydrogel as a tear film supplement: a masked controlled study. PLoS One. 2014 Jun 10;9(6):e99766. doi: 10.1371/journal.pone.0099766. eCollection 2014.
PMID: 24914681RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- The patients did not know the artificial tear that should be applied. The researcher in charge of processing the results and drawing the conclusions did not know the name of the artificial tears
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Optometry and Vision Science
Study Record Dates
First Submitted
July 16, 2018
First Posted
August 6, 2018
Study Start
October 1, 2017
Primary Completion
February 1, 2018
Study Completion
March 20, 2018
Last Updated
August 14, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share
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