Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-04-15 @ 7:18 AM
Study NCT ID:
NCT02177305
Status:
COMPLETED
Last Update Posted:
2014-06-27
First Post:
2014-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Tolerance Study After Ocular Administration of Tiotropium in Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'lastUpdateSubmitDate': '2014-06-26', 'studyFirstSubmitDate': '2014-06-20', 'studyFirstSubmitQcDate': '2014-06-26', 'lastUpdatePostDateStruct': {'date': '2014-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1998-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pupil diameter', 'timeFrame': 'baseline, after 24 hours'}, {'measure': 'Change in pupillary reflex', 'timeFrame': 'baseline, after 24 hours'}, {'measure': 'Change in intraocular pressure', 'timeFrame': 'baseline, after 24 hours'}, {'measure': 'Change in accommodation', 'timeFrame': 'baseline, after 24 hours'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in blood pressure', 'timeFrame': 'on Day 1 before and 24 hours after treatment and within 8 days after treatment day'}, {'measure': 'Change from baseline in pulse rate', 'timeFrame': 'on Day 1 before and 24 hours after treatment and within 8 days after treatment day'}, {'measure': 'Change in 12-lead ECG', 'timeFrame': 'on Day 1 before and 24 hours after treatment and within 8 days after treatment day'}, {'measure': 'Changes from baseline in standard laboratory examinations', 'timeFrame': 'Baseline and within 8 days after treatment day'}, {'measure': 'Occurrence of Adverse Events', 'timeFrame': 'until 8 days after treatment day'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Safety and tolerability after ocular administration'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males\n* Age range from 21 to 50 years\n* Within ± 20% of normal weight (Broca-Index)\n* Written informed consent given\n\nExclusion Criteria:\n\n* Results of the medical examinations or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values\n* Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n* Volunteers with disease of the central nervous system (such as epilepsy) or with psychiatric disorders\n* Volunteers with known history of orthostatic hypotension, fainting spells or blackouts\n* Volunteers with chronic or relevant acute infections\n* Volunteers with history of allergy/ hypersensitivity (including drug allergy)\n* Volunteers with known eye diseases (incl. glaucoma), with hyperopia (\\> 3 diopters) or with contact lenses\n* Volunteers with intraocular pressure \\> 22 mmHg\n* Volunteers with predisposition to narrow-angle glaucoma\n* Volunteers with disturbed micturition\n* Volunteers who have taken a drug with a long half-life (≥ 24 hours) within ten half-lives of the respective drug before enrolment in the study\n* Volunteers who received any other drugs which might influence the results of the trial during the week previous the start of the study\n* Volunteers who have participated in another study with an investigational drug within the last two months preceding this study\n* Volunteers who smoke (\\> 10 cigarettes or 3 cigars or 3 pipes/day)\n* Volunteers who are not able to refrain from smoking on study day\n* Volunteers who drink more than 40 g of alcohol per day\n* Volunteers who are dependent on drugs\n* Volunteers who have donated blood (≥ 100 ml) within the last four weeks\n* Volunteers who participated in excessive physical activities (e.g. competitive sports) within the last week before the study'}, 'identificationModule': {'nctId': 'NCT02177305', 'briefTitle': 'Dose Tolerance Study After Ocular Administration of Tiotropium in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Single Increasing Dose Tolerance Study After Ocular Administration of Tiotropium (Single Doses: 0.02 - 0.4 mcg) in Healthy Male Volunteers (Randomised, Placebo-controlled, Double-blind, Parallel Groups).', 'orgStudyIdInfo': {'id': '205.138'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tiotropium dose group 1', 'description': '0.02 mcg tiotropium solution', 'interventionNames': ['Drug: 0.02 mcg tiotropium solution', 'Drug: Placebo solution']}, {'type': 'EXPERIMENTAL', 'label': 'Tiotropium dose group 2', 'description': '0.04 mcg tiotropium solution', 'interventionNames': ['Drug: 0.04 mcg tiotropium solution', 'Drug: Placebo solution']}, {'type': 'EXPERIMENTAL', 'label': 'Tiotropium dose group 3', 'description': '0.08 mcg tiotropium solution', 'interventionNames': ['Drug: 0.08 mcg tiotropium solution', 'Drug: Placebo solution']}, {'type': 'EXPERIMENTAL', 'label': 'Tiotropium dose group 4', 'description': '0.16 mcg tiotropium solution', 'interventionNames': ['Drug: 0.16 mcg tiotropium solution', 'Drug: Placebo solution']}, {'type': 'EXPERIMENTAL', 'label': 'Tiotropium dose group 5', 'description': '0.28 mcg tiotropium solution', 'interventionNames': ['Drug: 0.28 mcg tiotropium solution', 'Drug: Placebo solution']}, {'type': 'EXPERIMENTAL', 'label': 'Tiotropium dose group 6', 'description': '0.40 mcg tiotropium solution', 'interventionNames': ['Drug: 0.40 mcg tiotropium solution', 'Drug: Placebo solution']}], 'interventions': [{'name': '0.02 mcg tiotropium solution', 'type': 'DRUG', 'armGroupLabels': ['Tiotropium dose group 1']}, {'name': '0.04 mcg tiotropium solution', 'type': 'DRUG', 'armGroupLabels': ['Tiotropium dose group 2']}, {'name': '0.08 mcg tiotropium solution', 'type': 'DRUG', 'armGroupLabels': ['Tiotropium dose group 3']}, {'name': '0.16 mcg tiotropium solution', 'type': 'DRUG', 'armGroupLabels': ['Tiotropium dose group 4']}, {'name': '0.28 mcg tiotropium solution', 'type': 'DRUG', 'armGroupLabels': ['Tiotropium dose group 5']}, {'name': '0.40 mcg tiotropium solution', 'type': 'DRUG', 'armGroupLabels': ['Tiotropium dose group 6']}, {'name': 'Placebo solution', 'type': 'DRUG', 'armGroupLabels': ['Tiotropium dose group 1', 'Tiotropium dose group 2', 'Tiotropium dose group 3', 'Tiotropium dose group 4', 'Tiotropium dose group 5', 'Tiotropium dose group 6']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}