Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
Study NCT ID:
NCT05878067
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2023-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Assess Symptom Relief and Product Tolerability of ABBV-444 Drops in Adult Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality and adverse event tables include events reported from enrollment to end of study. Safety events (per protocol) were collected from enrollment through the 30 day treatment period.', 'eventGroups': [{'id': 'EG000', 'title': 'ABBV-444', 'description': 'Participants administered 1-2 drops of ABBV-444 in each eye as needed but minimally twice a day for 30 days.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Day 30 in Ocular Surface Disease Index (OSDI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBV-444', 'description': 'Participants administered 1-2 drops of ABBV-444 in each eye as needed but minimally twice a day for 30 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.8', 'spread': '15.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 30', 'description': 'The OSDI is a 12-question survey for participants to document their dry eye disease symptoms. The OSDI consists of a 5-point scale ranging from 0 (none of the time) to 4 (all of the time), with higher scores representing greater disability. The scores from the 12 questions are totaled and converted to an overall score ranging from 0 (no disability) to 100 (complete disability). A negative number change from baseline represents an improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is based on the full analysis set (FAS), consisting of all participants who were eligible based on the inclusion and exclusion criteria and completed 30 days of treatment for this study.'}, {'type': 'SECONDARY', 'title': 'Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBV-444', 'description': 'Participants administered 1-2 drops of ABBV-444 in each eye as needed but minimally twice a day for 30 days.'}], 'classes': [{'title': 'The study eye drops do not cause stinging or burning in my eyes (5 minutes)', 'categories': [{'measurements': [{'value': '76.4', 'spread': '36.7', 'groupId': 'OG000'}]}]}, {'title': 'Study eye drops provided immediate relief of my eye dryness when putting in my eyes (5 minutes)', 'categories': [{'measurements': [{'value': '77.1', 'spread': '27.9', 'groupId': 'OG000'}]}]}, {'title': 'Study eye drops immediately soothed my eye dryness when putting in my eyes (5 minutes)', 'categories': [{'measurements': [{'value': '81.3', 'spread': '25.3', 'groupId': 'OG000'}]}]}, {'title': 'Did not experience much blurry/fluctuating vision after putting study eye drops in my eyes (5 mins)', 'categories': [{'measurements': [{'value': '77.5', 'spread': '30.4', 'groupId': 'OG000'}]}]}, {'title': 'Study eye drops provided immediate comfort to my eye dryness when putting in my eyes (5 minutes)', 'categories': [{'measurements': [{'value': '84.1', 'spread': '21.1', 'groupId': 'OG000'}]}]}, {'title': 'The study eye drops are very soothing for my eye dryness (30 minutes)', 'categories': [{'measurements': [{'value': '82.0', 'spread': '25.6', 'groupId': 'OG000'}]}]}, {'title': 'The study eye drops did not feel sticky (30 minutes)', 'categories': [{'measurements': [{'value': '78.6', 'spread': '30.8', 'groupId': 'OG000'}]}]}, {'title': 'The study eye drops continued to provide relief of my eye discomfort (30 minutes)', 'categories': [{'measurements': [{'value': '84.6', 'spread': '20.7', 'groupId': 'OG000'}]}]}, {'title': 'The study eye drops continued to provide comfort to my eye dryness (30 minutes)', 'categories': [{'measurements': [{'value': '85.7', 'spread': '21.0', 'groupId': 'OG000'}]}]}, {'title': 'The study eye drops provided relief of my eye dryness day and night (24 hours)', 'categories': [{'measurements': [{'value': '84.4', 'spread': '20.0', 'groupId': 'OG000'}]}]}, {'title': 'The study eye drops provided comfort to my eye dryness day and night (24 hours)', 'categories': [{'measurements': [{'value': '84.5', 'spread': '21.5', 'groupId': 'OG000'}]}]}, {'title': 'The study eye drops provided lasting relief of my eye dryness (5 days)', 'categories': [{'measurements': [{'value': '83.8', 'spread': '23.2', 'groupId': 'OG000'}]}]}, {'title': 'The study eye drops have provided relief during conditions that lead to eye dryness (5 days)', 'categories': [{'measurements': [{'value': '82.0', 'spread': '22.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 30', 'description': 'The PEDE Survey is a 13-item questionnaire that evaluates the short- and long-term subjective experience in comfort and vision as well as tolerability, using a scale ranging from 0 (strongly disagree) to 100 (strongly agree). On Day 30, participants were asked to retrospectively recall their experiences after 5 minutes, 30 minutes, 24 hours, and 5 days of when they administered the eye drops', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is based on the full analysis set (FAS), consisting of all participants who were eligible based on the inclusion and exclusion criteria and completed 30 days of treatment for this study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Symptom Scores (Visual Analog Scale) Within 5 Minutes Post Administration of ABBV-444', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBV-444', 'description': 'Participants administered 1-2 drops of ABBV-444 in each eye as needed but minimally twice a day for 30 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.1', 'spread': '10.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (T0) to 5 minutes (T5)', 'description': 'The Current Symptom Survey is a 5-item questionnaire where the participants rate their ocular symptoms at the present moment using a scale ranging from 0 (strongly disagree) to 100 (strongly agree). Surveys were completed 5 minutes following the first administration of study eye drops. A negative number change from baseline represents an improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is based on the full analysis set (FAS), consisting of all participants who were eligible based on the inclusion and exclusion criteria and completed 30 days of treatment for this study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ABBV-444', 'description': 'Participants administered 1-2 drops of ABBV-444 in each eye as needed but minimally twice a day for 30 days.\n\nABBV-444: Lubricant Eye drops'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'A total of 40 participants were enrolled and included in the intent-to-treat (ITT) population. The per-protocol (PP) population included 34 participants after excluding 4 participants who were deemed protocol deviations and 2 participants who discontinued the study. The per-protocol population was used for all efficacy measures.', 'preAssignmentDetails': 'Four participants were deemed protocol deviations following data entry and analysis because their baseline OSDI scores were outside the 18 to 65 inclusion range. The 4 participants were not included in the per protocol population.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'ABBV-444', 'description': 'Participants administered 1-2 drops of ABBV-444 in each eye as needed, but minimally twice a day for 30 days.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.7', 'spread': '15.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'ITT population: Includes all enrolled participants who received at least one dose of study drug'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-02', 'size': 6428804, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-27T14:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-23', 'studyFirstSubmitDate': '2023-05-24', 'resultsFirstSubmitDate': '2024-09-23', 'studyFirstSubmitQcDate': '2023-05-24', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-23', 'studyFirstPostDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Day 30 in Ocular Surface Disease Index (OSDI) Score', 'timeFrame': 'Baseline to Day 30', 'description': 'The OSDI is a 12-question survey for participants to document their dry eye disease symptoms. The OSDI consists of a 5-point scale ranging from 0 (none of the time) to 4 (all of the time), with higher scores representing greater disability. The scores from the 12 questions are totaled and converted to an overall score ranging from 0 (no disability) to 100 (complete disability). A negative number change from baseline represents an improvement.'}], 'secondaryOutcomes': [{'measure': 'Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale)', 'timeFrame': 'Day 30', 'description': 'The PEDE Survey is a 13-item questionnaire that evaluates the short- and long-term subjective experience in comfort and vision as well as tolerability, using a scale ranging from 0 (strongly disagree) to 100 (strongly agree). On Day 30, participants were asked to retrospectively recall their experiences after 5 minutes, 30 minutes, 24 hours, and 5 days of when they administered the eye drops'}, {'measure': 'Change From Baseline in Symptom Scores (Visual Analog Scale) Within 5 Minutes Post Administration of ABBV-444', 'timeFrame': 'Baseline (T0) to 5 minutes (T5)', 'description': 'The Current Symptom Survey is a 5-item questionnaire where the participants rate their ocular symptoms at the present moment using a scale ranging from 0 (strongly disagree) to 100 (strongly agree). Surveys were completed 5 minutes following the first administration of study eye drops. A negative number change from baseline represents an improvement.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dry Eye Syndrome', 'ABBV-444'], 'conditions': ['Dry Eye Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=P24-203', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Dry Eye Disease (DED) is a condition where the tear film of the eye becomes unstable and along with ocular surface inflammation and damage leads to inadequate tear production and eye lubrication. This study will evaluate symptom relief and tolerability of ABBV-444 eye drops in adult participants.\n\nABBV-444 is being developed for the treatment of Dry Eye Disease (DED). This is a 30-day, open-label study to evaluate adult participant symptoms and tolerability of ABBV-444. Around 40 participants will be enrolled in 1 site in the United States.\n\nParticipants will receive 1-2 drops of ABBV-444 in each eye as needed but minimally twice a day for 30 days.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Had used artificial tears for dry eyes within the past year\n* OSDI score of ≥ 18 and ≤ 65 (based upon a 0 to 100 scale) at Screening and Baseline Visits Three consecutive tear breakup time (TBUT) tests ≤ 10 seconds in at least 1 eye at Day -7 (screening)\n* Grade 1 to 4 (modified National Eye Institute \\[NEI\\] Grid, score range = 0 to 5) staining in at least 1 area of the cornea (5 areas examined) or conjunctiva (6 areas examined) that was related to dry eye in at least 1 eye at both at Screening and Baseline Visits\n\nExclusion Criteria:\n\n* Have uncontrolled severe systemic disease that, in the assessment of the investigator, would put safety of the participant at risk through participation, or which would prevent or confound protocol-specified assessments (e.g., hypertension and diabetes, Sjögren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, immunodeficiency disease, etc.)\n* Known allergy or sensitivity to the study products or their components\n* Schirmer Test (with anesthesia) ≤ 2 mm in either eye at Screening Visit\n* Participant anticipated contact lens wear during the study, or the participant had worn contact lenses in the last 3 months prior to Screening Visit"}, 'identificationModule': {'nctId': 'NCT05878067', 'briefTitle': 'A Study to Assess Symptom Relief and Product Tolerability of ABBV-444 Drops in Adult Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Patient Experience Study With ABBV-444 for Symptom Relief and Tolerability', 'orgStudyIdInfo': {'id': 'P24-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABBV-444', 'description': 'Participants will administer 1-2 drops of ABBV-444 in each eye as needed but minimally twice a day for 30 days.', 'interventionNames': ['Drug: ABBV-444']}], 'interventions': [{'name': 'ABBV-444', 'type': 'DRUG', 'description': 'Lubricant Eye drops', 'armGroupLabels': ['ABBV-444']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91702', 'city': 'Azusa', 'state': 'California', 'country': 'United States', 'facility': 'Canyon City Eyecare /ID# 253652', 'geoPoint': {'lat': 34.13362, 'lon': -117.90756}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/abbvie/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}