Ignite Creation Date:
2025-12-24 @ 4:22 PM
Ignite Modification Date:
2025-12-31 @ 8:08 AM
Study NCT ID:
NCT01384266
Status:
COMPLETED
Last Update Posted:
2017-06-29
First Post:
2011-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of 0.5% Loteprednol Etabonate Versus 1% Prednisolone Acetate Following Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014605', 'term': 'Uveitis'}], 'ancestors': [{'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-28', 'studyFirstSubmitDate': '2011-01-13', 'studyFirstSubmitQcDate': '2011-06-27', 'lastUpdatePostDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular inflammation grading', 'timeFrame': 'Day 21 Post-op', 'description': 'Slit Lamp examination will be done at each visit to grade intraocular inflammation'}], 'secondaryOutcomes': [{'measure': 'Intraocular pressure spikes', 'timeFrame': 'Day 21 post-op', 'description': 'Intraocular pressure(IOP) will be measured at each visit.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intraocular Inflammation following routine Cataract Surgery'], 'conditions': ['Intraocular Inflammation']}, 'descriptionModule': {'briefSummary': 'Patients are routinely given steroid eye drops following cataract surgery. This study will compare 2 approved drops:Loteprednol Etabonate versus Prednisolone Acetate Eye drops used following cataract surgery. Patients will be randomly assigned to one drop or the other, and evaluated for inflammation and intraocular pressure as part of the comparison. The study Doctor will be masked as to which drop the patient receives to avoid bias.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Eye Clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects age 18 and older undergoing routine cataract surgery.\n\nExclusion Criteria:\n\n1. Subjects being treated for elevated intraocular pressure, retinopathy, maculopathy, cornea or vitreous opacities that would interfere with visual acuity.\n2. Subjects with diabetes, pseudoexfoliation, uveitis, corneal endothelial disease, or active Herpes Simplex Virus(HSV) or Herpes Zoster Virus(HZV) Pupil Stretch and/or Limbal Relaxing Incision(LRIs) will be allowed.\n3. Subjects with previous ocular trauma or intraocular surgery\n4. Subjects with sensitivities to steroids.\n5. Women who are not post-menopausal or are of child bearing potential will be excluded.\n6. Intraoperative complications during surgery including posterior capsule rupture and vitreous loss\n7. Subjects with best visual potential in the fellow eye worse than 20/60\n8. Subjects who are expected to require concurrent ocular or systemic therapy with non-steroidal anti-inflammatory drugs (NSAIDS) mast cell stabilizers, antihistamines, or decongestants within 2 days prior to or during the 21 days following surgery. (Intraoperative NSAIDS for mydriasis are permitted.) 325 mg Aspirin is permitted.\n9. Subjects who are expected to require concurrent ocular or systemic corticosteroids, immunosuppressants (including Restasis) within 14 days prior to or 21 days following surgery'}, 'identificationModule': {'nctId': 'NCT01384266', 'briefTitle': 'A Comparison of 0.5% Loteprednol Etabonate Versus 1% Prednisolone Acetate Following Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Associated Eye Care, Minnesota'}, 'officialTitle': 'A Randomized, Multicenter, Masked Evaluation of 0.5% Loteprednol Etabonate Versus 1% Prednisolone Acetate for the Treatment of Inflammation Following Cataract Surgery', 'orgStudyIdInfo': {'id': 'AEC-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects undergoing Cataract Surgery', 'description': 'Subjects undergoing routine cataract surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '41017', 'city': 'Edgewood', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Cincinnati Eye Institute', 'geoPoint': {'lat': 39.01867, 'lon': -84.58189}}, {'zip': '55082', 'city': 'Stillwater', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Associated Eye Care', 'geoPoint': {'lat': 45.05636, 'lon': -92.80604}}], 'overallOfficials': [{'name': 'Stephen S Lane, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associated Eye Care'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Associated Eye Care, Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prinicipal Investigator', 'investigatorFullName': 'Stephen S. Lane, MD', 'investigatorAffiliation': 'Associated Eye Care, Minnesota'}}}}