Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT07122635
Status:
COMPLETED
Last Update Posted:
2025-08-14
First Post:
2025-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Dry Eye Treatment With Diquafosol Sodium 3% After Phaco Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2025-07-07', 'studyFirstSubmitQcDate': '2025-08-07', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rate of side effects of diquafosol', 'timeFrame': 'From starting diquafosol (baseline) to 12 weeks', 'description': 'Rate of side effects of diquafosol will be assessed at each examination.'}, {'measure': 'Influence of Risk Factors on Treatment Effectiveness', 'timeFrame': 'From starting diquafosol (baseline) to 12 weeks', 'description': "The influence of risk factors on treatment effectiveness will be evaluated (yes or no, influence or not). A Fisher's Exact Test will determine if there is a statistically significant difference (p\\<0.05) between subgroups of a specific risk factor."}], 'primaryOutcomes': [{'measure': 'Change in OSDI score', 'timeFrame': 'From starting diquafosol (baseline) to 12 weeks', 'description': 'Change in OSDI score after treatment with diquafosol from baseline (1 week after surgery) to 4 weeks, 8 weeks, 12 weeks.\n\nAt the preoperative and postoperative examinations, patient will be evaluated dry eye symptoms according to the OSDI questionnaire (from 0-100 points)'}, {'measure': 'Change in Tear film breakup time (TBUT) score', 'timeFrame': 'From starting diquafosol (baseline) to 12 weeks', 'description': 'Change in tear film breakup time (TBUT) score after treatment with diquafosol from baseline (1 week after surgery) for 4 weeks, 8 weeks, 12 weeks.\n\nAt the preoperative and postoperative examinations, patient will be evaluated tear film breakup time which is measured after fluorescein staining. At each examination, TBUT score is measured 3 times to calculate the average value.'}], 'secondaryOutcomes': [{'measure': 'Change in Schirmer I test value', 'timeFrame': 'From starting diquafosol (baseline) to 12 weeks', 'description': 'Change in Schirmer I test value after treatment with diquafosol from baseline (1 week after surgery) for 4 weeks, 8 weeks, 12 weeks.\n\nAt the preoperative and postoperative examinations, patient will be evaluated total tear secretion using the Schirmer I test.'}, {'measure': 'Change in Tear meniscus height', 'timeFrame': 'From starting diquafosol (baseline) to 12 weeks', 'description': 'Change in Tear meniscus height after treatment with diquafosol from baseline (1 week after surgery) for 4 weeks, 8 weeks, 12 weeks.\n\nAt the preoperative and postoperative examinations, tear meniscus height will be measured using TMH mode on Keratograph 5M machine.'}, {'measure': 'Change in Corneal staining score', 'timeFrame': 'From starting diquafosol (baseline) to 12 weeks', 'description': 'Change in corneal staining score after treatment with diquafosol from baseline (1 week after surgery) for 4 weeks, 8 weeks, 12 weeks.\n\nAt the preoperative and postoperative examinations, patient will be evaluated corneal staining score, which is measured after fluorescein staining and calculated according to NEI grading scale.'}, {'measure': 'Change in Conjunctival staining score', 'timeFrame': 'From starting diquafosol (baseline) to 12 weeks', 'description': 'Change in conjunctival staining score after treatment with diquafosol from baseline (1 week after surgery) for 4 weeks, 8 weeks, 12 weeks.\n\nAt the preoperative and postoperative examinations, patient will be evaluated conjunctival staining score, which is measured after Lissamine green staining and calculated according to NEI grading scale.'}, {'measure': 'Change in Tear film breakup pattern', 'timeFrame': 'From starting diquafosol (baseline) to 12 weeks', 'description': 'Change in tear film breakup pattern from baseline (1 week after surgery) and after 12 weeks of treatment with diquafosol.\n\nTear film breakup pattern will be assessed after fluorescein staining.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diquafosol', 'dry eye', 'phaco surgery', 'cataract surgery'], 'conditions': ['Dry Eye Disease']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to evaluate the effectiveness of diquafosol sodium 3% in patients undergoing phacoemulsification surgery and having dry eye 1 week after the surgery. The main question it aims to answer is whether using diquafosol will help improve symptoms and signs of dry eye in patients after phaco surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with grade 1, grade 2 or grade 3 dry eye according to DEWS 2007 classification and Sullivan's severity grading scheme one week after phacoemulsification surgery with IOL implantation", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients undergoing phacoemulsification surgery with IOL implantation\n* Diagnosis with grade 1, grade 2 or grade 3 dry eye one week after the surgery according to DEWS 2007 classification and Sullivan's severity grading scheme\n\nExclusion Criteria:\n\n* Patients with grade 3 or 4 dry eye before phaco surgery\n* Phaco surgery with complications during or after surgery\n* Patients with other eye surgeries within 6 months before phaco surgery\n* Patients who are using other eye drops before phaco surgery, except artificial tears\n* Patients with acute eye infections\n* Patients who do not return for follow-up appointments\n* Patients who do not comply with treatment\n* Patients having allergy with diquafosol 3%\n* Patients having side effects with diquafosol 3% and do not want to continue using the drug"}, 'identificationModule': {'nctId': 'NCT07122635', 'briefTitle': 'Effectiveness of Dry Eye Treatment With Diquafosol Sodium 3% After Phaco Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Vietnam National Eye Hospital'}, 'officialTitle': 'Effectiveness of Dry Eye Treatment With Diquafosol Sodium 3% After Phaco Surgery', 'orgStudyIdInfo': {'id': '764/QD-BVMTW No. 17'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing phacoemulsification surgery and having dry eye 1 week after the surgery', 'interventionNames': ['Drug: Diquafosol Sodium 3%']}], 'interventions': [{'name': 'Diquafosol Sodium 3%', 'type': 'DRUG', 'description': 'Diquafosol Sodium 3% ophthalmic solution, 1 drop each time, 6 times daily, from baseline (1 week after the surgery) to 12 weeks', 'armGroupLabels': ['Patients undergoing phacoemulsification surgery and having dry eye 1 week after the surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Hanoi', 'country': 'Vietnam', 'facility': 'Vietnam National Eye Hospital', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Le Xuan Cung', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Cornea Department', 'investigatorFullName': 'Le Xuan Cung', 'investigatorAffiliation': 'Vietnam National Eye Hospital'}}}}