Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT03000556
Status:
UNKNOWN
Last Update Posted:
2016-12-22
First Post:
2016-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
0.3% Sodium Hyaluronate Eye Drop to Prevent Recurrent Corneal Epithelium Exfoliation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-19', 'studyFirstSubmitDate': '2016-12-14', 'studyFirstSubmitQcDate': '2016-12-19', 'lastUpdatePostDateStruct': {'date': '2016-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the incidence of recurrent corneal epithelium exfoliation', 'timeFrame': '6 month', 'description': 'Recurrent corneal epithelial exfoliation was defined as positive staining of corneal fluorescein by slit lamp microscope and the patient had obvious eye pain.'}], 'secondaryOutcomes': [{'measure': 'the incidence of recurrent corneal epithelium exfoliation', 'timeFrame': '1 year', 'description': 'Recurrent corneal epithelial exfoliation was defined as positive staining of corneal fluorescein by slit lamp microscope and the patient had obvious eye pain.'}, {'measure': 'corneal fluorescein staining score', 'timeFrame': '1 year', 'description': 'Grading of corneal epithelial fluorescein sodium staining under slit lamp. The average cornea was divided into four quadrants and scored separately, adding all the scores to get the final score. Scoring criteria: 0 point: no staining; 1 point: punctate staining less than 30 dots; 2 points: punctate staining more than 30 dots, more than the point of the color but not scattered; 3 points: severe dispersion staining but no plaque staining; 4 points: plaque staining. Maximum score of 16 points per eye.'}, {'measure': 'Corneal edema grading', 'timeFrame': '1 year', 'description': 'Grading of corneal edema under slit lamp. 0 point: Căcorneal transparency without edema; 1 point: corneal haze edema, corneal endothelium smooth, iris texture is clearly visible; 2 points: corneal surface roughness, iris texture fuzzy; 3 points: corneal endothelial surface cracking, iris texture as is not clear; 4 points: white corneal edema, intraocular structure as unclear.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Corneal Epithelium Exfoliation']}, 'referencesModule': {'references': [{'pmid': '33369934', 'type': 'DERIVED', 'citation': 'Wei M, Zou Y, Duan F, Ding X, Zhuang J, Deng J, Yuan Z. Efficacy of Long-term Use of 0.3% Sodium Hyaluronate Eye Drops for Traumatic Corneal Abrasion: A Randomized Controlled, Pilot Trial. Cornea. 2021 Oct 1;40(10):1248-1252. doi: 10.1097/ICO.0000000000002625.'}]}, 'descriptionModule': {'briefSummary': 'Corneal abrasion (TCA) is the most common ophthalmic emergency disease, accounting for about 10% of the American ophthalmic emergency, accounting for 22% of the ophthalmic emergency in Zhongshan Ophthalmic Center. Clinical emergency treatment of TCA is relatively simple and effective, corneal epithelial damage can be recovered within 48 hours. However, about 25% TCA would be developed to the recurrence of exfoliation. Once the recurrence of TCA, the treatment would be more difficult and even cause blindness. Therefore, it is of great practical significance to prevent the recurrence of TCA. However, there is no effective methods to prevent recurrence of TCA.\n\n0.3% sodium hyaluronate eye drops can effectively supplement the shortage of tear and promote repair of corneal epithelium. On this basis, the investigators hypotheses that 0.3% sodium hyaluronate eye drops can prevent the recurrence of TCA. So, investigators intend to test effectiveness of 0.3% sodium hyaluronate drops to prevent the recurrence of TCA by a prospective, single center, randomized, controlled pilot study. In this study, 60 patients with TCA were randomly divided into control group and sodium hyaluronate treatment group and observed one year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Definitive diagnosis of primary corneal epithelial abrasion;\n* Monocular onset;\n* Corneal epithelium was defected and fluorescein sodium staining was positive.\n\nExclusion Criteria:\n\n* Corneal epithelial defect complicated with infection\n* Associated with other ocular surface disease patients (such as hypophasis, meibomian gland dysfunction, keratoconjunctivitis sicca syndrome, bullous keratopathy, corneal dystrophy and drug-induced corneal toxicity etc.)\n* Pregnant or lactating women; serious heart, liver, and kidney dysfunction; mental disorders; other inflammatory or autoimmune diseases'}, 'identificationModule': {'nctId': 'NCT03000556', 'briefTitle': '0.3% Sodium Hyaluronate Eye Drop to Prevent Recurrent Corneal Epithelium Exfoliation', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': '0.3% Sodium Hyaluronate Eye Drop to Prevent Recurrent Corneal Epithelium Exfoliation After Corneal Abrasions: a Pilot Study', 'orgStudyIdInfo': {'id': 'AL-2016-DF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experience', 'interventionNames': ['Drug: 0.3% Sodium Hyaluronate Eye Drop']}, {'type': 'NO_INTERVENTION', 'label': 'control'}], 'interventions': [{'name': '0.3% Sodium Hyaluronate Eye Drop', 'type': 'DRUG', 'description': 'The patients need to use 0.3% Sodium Hyaluronate Eye Drop for 3 month.', 'armGroupLabels': ['experience']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fang Duan', 'role': 'CONTACT', 'email': 'duanfangg@126.com', 'phone': '86-20-87331537'}, {'name': 'Zhaohui Yuan', 'role': 'CONTACT', 'email': 'zhaohui1208@qq.com', 'phone': '86-20-87331537'}], 'facility': 'Zhongshan ophthalmic center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Fang Duan, doctor', 'role': 'CONTACT', 'email': 'duanfangg@126.com', 'phone': '8613710790313'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fang Duan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'clinical professor', 'investigatorFullName': 'Fang Duan', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}