Nctid:
NCT06221345
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000002386", "term"=>"Cataract"}, {"id"=>"D000015352", "term"=>"Dry Eye Syndromes"}, {"id"=>"D000007638", "term"=>"Keratoconjunctivitis Sicca"}, {"id"=>"D000005128", "term"=>"Eye Diseases"}], "ancestors"=>[{"id"=>"D000007905", "term"=>"Lens Diseases"}, {"id"=>"D000007766", "term"=>"Lacrimal Apparatus Diseases"}, {"id"=>"D000007637", "term"=>"Keratoconjunctivitis"}, {"id"=>"D000003231", "term"=>"Conjunctivitis"}, {"id"=>"D000003229", "term"=>"Conjunctival Diseases"}, {"id"=>"D000007634", "term"=>"Keratitis"}, {"id"=>"D000003316", "term"=>"Corneal Diseases"}], "browseLeaves"=>[{"id"=>"M18040", "name"=>"Dry Eye Syndromes", "asFound"=>"Dry Eye Disease", "relevance"=>"HIGH"}, {"id"=>"M10664", "name"=>"Keratoconjunctivitis Sicca", "asFound"=>"Dry Eye Disease", "relevance"=>"HIGH"}, {"id"=>"M15241", "name"=>"Rupture", "relevance"=>"LOW"}, {"id"=>"M5638", "name"=>"Cataract", "asFound"=>"Cataract", "relevance"=>"HIGH"}, {"id"=>"M8271", "name"=>"Eye Diseases", "asFound"=>"Eye Disease", "relevance"=>"HIGH"}, {"id"=>"M22785", "name"=>"Lacerations", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10663", "name"=>"Keratoconjunctivitis", "relevance"=>"LOW"}, {"id"=>"M10917", "name"=>"Lens Diseases", "relevance"=>"LOW"}, {"id"=>"M10786", "name"=>"Lacrimal Apparatus Diseases", "relevance"=>"LOW"}, {"id"=>"M6455", "name"=>"Conjunctivitis", "relevance"=>"LOW"}, {"id"=>"M6453", "name"=>"Conjunctival Diseases", "relevance"=>"LOW"}, {"id"=>"M10660", "name"=>"Keratitis", "relevance"=>"LOW"}, {"id"=>"M6539", "name"=>"Corneal Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Eye Diseases", "abbrev"=>"BC11"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000009883", "term"=>"Ophthalmic Solutions"}, {"id"=>"D000065346", "term"=>"Lubricant Eye Drops"}], "ancestors"=>[{"id"=>"D000019999", "term"=>"Pharmaceutical Solutions"}], "browseLeaves"=>[{"id"=>"M9878", "name"=>"Hyaluronic Acid", "relevance"=>"LOW"}, {"id"=>"M30370", "name"=>"Levofloxacin", "relevance"=>"LOW"}, {"id"=>"M17946", "name"=>"Ofloxacin", "relevance"=>"LOW"}, {"id"=>"M12814", "name"=>"Ophthalmic Solutions", "asFound"=>"Plane", "relevance"=>"HIGH"}, {"id"=>"M14120", "name"=>"Prednisolone", "relevance"=>"LOW"}, {"id"=>"M1833", "name"=>"Methylprednisolone Acetate", "relevance"=>"LOW"}, {"id"=>"M11749", "name"=>"Methylprednisolone", "relevance"=>"LOW"}, {"id"=>"M11750", "name"=>"Methylprednisolone Hemisuccinate", "relevance"=>"LOW"}, {"id"=>"M229449", "name"=>"Prednisolone acetate", "relevance"=>"LOW"}, {"id"=>"M211887", "name"=>"Prednisolone hemisuccinate", "relevance"=>"LOW"}, {"id"=>"M248881", "name"=>"Prednisolone phosphate", "relevance"=>"LOW"}, {"id"=>"M5524", "name"=>"Carboxymethylcellulose Sodium", "relevance"=>"LOW"}, {"id"=>"M30506", "name"=>"Lubricant Eye Drops", "asFound"=>"Wound care", "relevance"=>"HIGH"}, {"id"=>"M21860", "name"=>"Pharmaceutical Solutions", "relevance"=>"LOW"}, {"id"=>"T176", "name"=>"Guar", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Pharmaceutical Solutions", "abbrev"=>"PhSol"}, {"name"=>"Anti-Inflammatory Agents", "abbrev"=>"Infl"}, {"name"=>"Antiemetics", "abbrev"=>"AnEm"}, {"name"=>"Neuroprotective Agents", "abbrev"=>"NeuroAg"}, {"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}, {"name"=>"Herbal and Botanical", "abbrev"=>"HB"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE4"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>70}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2021-12-07", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2023-07-05", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-13", "studyFirstSubmitDate"=>"2024-01-02", "studyFirstSubmitQcDate"=>"2024-01-13", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-07-05", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Corneal fluorescein staining (CFS) score", "timeFrame"=>"Change from baseline to Weeks 1 and 3", "description"=>"The CFS will be evaluated by external eye photography using the National Eye Institute (NEI) staining grid in which a score of 0 (normal) to 3 (severe) will be assigned to each of the 5 corneal regions (nasal, central, temporal, superior, and inferior). The CFS score will range between 0 and 15, and the maximum score of 15 indicates severe epitheliopathy."}], "secondaryOutcomes"=>[{"measure"=>"Ocular Surface Disease Index (OSDI)", "timeFrame"=>"Change from baseline to Weeks 1 and 3", "description"=>"The OSDI score is a 12-item patient-reported outcomes questionnaire with an overall score ranging from 0 to 100 to assess ocular surface symptoms, and the subjects can be categorized as having a normal (0-12), mild (13-22), moderate (23-32), or severe (33-100) ocular surface disease based on their OSDI score."}, {"measure"=>"Schirmer's test (without anesthesia)", "timeFrame"=>"Change from baseline to Weeks 1 and 3", "description"=>"Schirmer's test is a quantitative test to measure maximal tear secretion capacity. A filter paper will be placed in the lower fornix for 5 min and the and the length of wetted paper is measured.While a Schirmer's test score of greater than 10 mm/5 min is classified as normal, test score of less than 5 mm/5 min indicates tear deficiency."}, {"measure"=>"Tear break-up time (TBUT)", "timeFrame"=>"Change from baseline to Weeks 1 and 3", "description"=>"TBUT is used to assess the tear film stability by recording the interval between the last blink and the first appearance of a dry spot. TBUT less than 10 sec suggests an abnormal tear film. While TBUT between 5 to 10 sec is considered marginal, TBUT less than 5 sec indicates dry eye."}, {"measure"=>"Central corneal sensitivity", "timeFrame"=>"Change from baseline to Weeks 1 and 3", "description"=>"Central corneal sensitivity will be measured using a Cochet-Bonnet esthesiometer. The 6.0-cm long nylon monofilament was held perpendicular to the subject's cornea and reduced at an interval of 0.5 cm until the subject reported that he/she was aware of the discomfort. The longer the length of the monofilament used, the greater sensitivity the subjects have."}, {"measure"=>"Slit-lamp examination", "timeFrame"=>"Change from baseline to Weeks 1 and 3", "description"=>"The slit-lamp examinations allow the physicians to identify dry eye signs on the subject. The eye structures (eyelids, cornea, and conjunctiva) of the subjects will be graded based on the United States Food and Drug Administration (FDA) grading system. While Grade 0 represents normal, the highest grade (i.e., Grade 4) indicates the subject may have very severe changes that require intervention, often medical."}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Hyaluronic Acid", "Hydroxypropyl guar", "Carboxymethylcellulose"], "conditions"=>["Dry Eye Disease", "Cataract"]}, "descriptionModule"=>{"briefSummary"=>"To compare the effects of hydroxypropyl guar (HPG)/hyaluronic acid (HA)- and carboxymethylcellulose (CMC)/HA-based lubricant eye drops on subjective and objective outcomes in dry eye disease (DED) patients after cataract surgery.", "detailedDescription"=>"This is a prospective, open-label, assessor-masked, interventional, randomized controlled study. A total of 70 post-cataract surgery dry-eye subjects are planned to be enrolled after eligibility confirmation at Week 1 post-operative (post-op). The subjects will then be randomized in a 1:1 ratio to either HPG/HA (Systane HYDRATION® ) or CMC/HA (Optive Fusion®) group.\n\nFrom Week 1 to 3 (1st to 4th week post-op), the HPG/HA group will receive Systane HYDRATION® Preservative-Free Lubricant Eye Drops whereas the CMC/HA group will receive Optive Fusion® Lubricant Eye Drops (Unit Dose). Both groups will receive 1-2 drops of artificial tears 4 times daily for 3 weeks.\n\nThere are three visits scheduled in this study, i.e., screening, Week 1, and Week 3. The subjects will return to the study sites during these visits for efficacy and safety assessments."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"20 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Male or female patients of any race, 20 years or older who are scheduled for unilateral cataract surgery.\n2. DED patients whose symptoms and signs are aggravated at baseline assessment after cataract surgery will be eligible for this study. Postoperative dry eye diagnosis criteria at baseline assessment:\n\n 1. OSDI score \\>14.8\\* (\\*Eligible subject mandatory required);\n 2. positive CFS\\* (\\*Eligible subject mandatory required);\n 3. Schirmer's test score ≤10 mm in 5 minutes (min) (without anesthesia);\n 4. TBUT ≤5 seconds (sec)\n\nExclusion Criteria:\n\n1. Patients with allergy to any of the study medications, conjunctival allergy or infectious disease, history of ocular chemical or thermal burn, Stevens-Johnson syndrome or ocular pemphigoid, glaucoma or ocular hypertension, eyelid or lacrimal disease, any ocular operation within 3 months, graft-versus-host disease (GVHD), non-dry-eye ocular inflammation, trauma, or presence of uncontrolled systemic disease.\n2. Before enrollment, corneal contact lens wear, history of severe systemic disease, or other conditions in the Investigator's opinion precluded enrollment.\n3. Patients will be withdrawn from the study if they experience complications during surgery, or post-surgical ocular hypertension, endophthalmitis, or infectious keratitis."}, "identificationModule"=>{"nctId"=>"NCT06221345", "briefTitle"=>"Hyaluronic Acid-containing Artificial Tears in Post-cataract Surgery Dry Eye Disease", "organization"=>{"class"=>"OTHER", "fullName"=>"Chang Gung Memorial Hospital"}, "officialTitle"=>"Comparison of Different Hyaluronic Acid-containing Artificial Tears on the Ocular Surface Disease in Patients With Post-cataract Surgery Dry Eye", "orgStudyIdInfo"=>{"id"=>"60298913"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"HPG/HA group", "description"=>"Systane HYDRATION®", "interventionNames"=>["Drug: Systane HYDRATION® Preservative-Free Lubricant Eye Drops"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"CMC/HA group", "description"=>"Optive Fusion®", "interventionNames"=>["Drug: Optive Fusion® Lubricant Eye Drops (Unit Dose)"]}], "interventions"=>[{"name"=>"Systane HYDRATION® Preservative-Free Lubricant Eye Drops", "type"=>"DRUG", "description"=>"The HPG/HA group will receive Systane HYDRATION® Preservative-Free Lubricant Eye Drops and standard of care, i.e., prednisolone acetate (Pred forte®) and levofloxacin (Cravit®), at the dosage of 1-2 drops 4 times daily for 3 weeks from Weeks 1 to 4 post-op", "armGroupLabels"=>["HPG/HA group"]}, {"name"=>"Optive Fusion® Lubricant Eye Drops (Unit Dose)", "type"=>"DRUG", "description"=>"The CMC/HA group will receive Optive Fusion® Lubricant Eye Drops (Unit Dose) and standard of care, i.e., prednisolone acetate (Pred forte®) and levofloxacin (Cravit®), at the dosage of 1-2 drops 4 times daily for 3 weeks from Weeks 1 to 4 post-op", "armGroupLabels"=>["CMC/HA group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Keelung", "country"=>"Taiwan", "facility"=>"Keelung Chang Gung Memorial Hospital", "geoPoint"=>{"lat"=>25.12825, "lon"=>121.7419}}], "overallOfficials"=>[{"name"=>"Chi-Chin Sun, M.D, Ph.D", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Chang Gung Memorial Hospital"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Chang Gung Memorial Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Professor, School of Medicine Chang Gung University Taoyuan, Taiwan ; Doctor, Department of Ophthalmology, Chang Gung Memorial Hospital, Keelung, Taiwan", "investigatorFullName"=>"CHI-CHIN-SUN", "investigatorAffiliation"=>"Chang Gung Memorial Hospital"}}}}
