Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT00413751
Status:
COMPLETED
Last Update Posted:
2006-12-20
First Post:
2006-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Brimonidine Tartrate Ophthalmic Solution 0.15% on Pupil Diameter in Normal Eyes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004172', 'term': 'Diplopia'}], 'ancestors': [{'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068438', 'term': 'Brimonidine Tartrate'}], 'ancestors': [{'id': 'D011810', 'term': 'Quinoxalines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-12', 'lastUpdateSubmitDate': '2006-12-19', 'studyFirstSubmitDate': '2006-12-19', 'studyFirstSubmitQcDate': '2006-12-19', 'lastUpdatePostDateStruct': {'date': '2006-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-20', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Large pupils rendering night vision difficulties such as haloes, glare, and monocular diplopia'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the effect of brimonidine tartrate ophthalmic solution 0.15% (Alphagan P) on pupil diameter under different luminance conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult active duty personnel between 18 and 50 years of age with best corrected visual acuity of 20/20 or better.\n\nExclusion Criteria:\n\n* Patients not meeting above stated age criteria\n* Females that are pregnant or lactating (non pregnant females of childbearing potential will have pregnancy test prior to participating in study)\n* History of serious ocular, neurological, cardiovascular disease\n* History of severe systemic disease\n* History of arrhythmias or high blood pressure\n* Patients currently taking any type of ocular or systemic medications except multivitamins.\n* Patients with abnormal pupil shape, Addie's pupil, anisocoria, or abnormal pupil defect."}, 'identificationModule': {'nctId': 'NCT00413751', 'briefTitle': 'Effect of Brimonidine Tartrate Ophthalmic Solution 0.15% on Pupil Diameter in Normal Eyes', 'organization': {'class': 'FED', 'fullName': 'Walter Reed Army Medical Center'}, 'orgStudyIdInfo': {'id': 'WRAMC WU #03-23004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Brimonidine tartrate ophthalmic solution 0.15% (Alphagan P)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20307', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Walter Reed Army Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'KRAIG S. BOWER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Walter Reed Army Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Walter Reed Army Medical Center', 'class': 'FED'}}}}