Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-04 @ 9:36 AM
Study NCT ID:
NCT00840268
Status:
COMPLETED
Last Update Posted:
2014-07-17
First Post:
2009-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Hydroxypropyl Guar Galactomannan 0.25% (HPGG) Versus Vehicle in Dry Eye Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 427}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'dispFirstSubmitDate': '2014-07-15', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-15', 'studyFirstSubmitDate': '2009-02-06', 'dispFirstSubmitQcDate': '2014-07-15', 'studyFirstSubmitQcDate': '2009-02-09', 'dispFirstPostDateStruct': {'date': '2014-07-17', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-07-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change from baseline in sodium fluorescein corneal staining score', 'timeFrame': 'Baseline (Day 7), Up to Day 28'}], 'secondaryOutcomes': [{'measure': 'Mean change from baseline in Dry Eye Symptom Questionnaire (OSDI) score', 'timeFrame': 'Baseline (Day 7), Up to Day 28'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['OSDI', 'corneal staining', 'Dry Eye', 'Dry Eye Signs and Symptoms in Dry Eye Patients'], 'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate efficacy of Hydroxypropyl Guar Galactomannan 0.25% (HPGG) ophthalmic gel compared to Vehicle for the treatment of dry eye.', 'detailedDescription': 'A 7-day Vehicle pre-randomization (run-in) phase during which all patients will receive 1 drop of Vehicle in each eye twice daily will precede the 21-day treatment phase, for an overall study duration of 28 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Must read, sign, and date an informed consent document and HIPAA privacy document.\n* Diagnosis of dry eye at Visit 1 (Day 0).\n* Able and willing to follow study instructions.\n* Best corrected visual acuity (BCVA) of 0.6 logMAR or better in each eye as assessed using an ETDRS chart at Visit 1.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Diagnosis of Sjogren's syndrome (or suspected to have Sjogren's syndrome).\n* History or evidence of ocular or intraocular surgery in either eye within the previous year.\n* History or evidence of serious ocular trauma in either eye within the previous 6 months.\n* History or evidence of corneal transplant or transplant variant procedures.\n* History of intolerance or hypersensitivity to any component of the study medications.\n* History of glaucoma or current ocular hypertension in either eye, or treatment for either condition within 6 months prior to Visit 1.\n* History or evidence of corneal conditions, other than dry eye, that may affect the corneal structure.\n* Use of any concomitant topical ocular medications including artificial tears during the study period.\n* Females of childbearing potential if breastfeeding, unwilling to undergo urine pregnancy test at screening and upon exiting the study, have a positive urine pregnancy test at screening, intend to become pregnant during the study, or do not agree to use adequate birth control methods for the duration of the study.\n* Use of RESTASIS® 0.05% or an ocular steroid within 30 days of Visit 1.\n* Use of systemic medications that have not been stable for 30 days prior to Visit 1.\n* Any ocular condition that may preclude the safe administration of the test article.\n* Unwilling to discontinue contact lens wear at least 4 weeks prior to Visit 1, and during the study period.\n* Use of punctal plugs or punctal cautery.\n* Use of lid scrubs/warm compresses within 14 days of Visit 1.\n* Other protocol-defined exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT00840268', 'briefTitle': 'A Study of Hydroxypropyl Guar Galactomannan 0.25% (HPGG) Versus Vehicle in Dry Eye Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'C-08-34'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HPGG 0.25%', 'description': 'Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel, 1 drop per eye twice daily (BID) (in the morning upon awakening and in the evening prior to bedtime) for 21 days (Treatment phase).', 'interventionNames': ['Drug: Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'HPGG Vehicle', 'description': 'Hydroxypropyl Guar Galactomannan Vehicle, 1 drop per eye twice daily (BID) (in the morning upon awakening and in the evening prior to bedtime) for 21 days (Treatment phase).', 'interventionNames': ['Drug: Hydroxypropyl Guar Galactomannan Vehicle']}], 'interventions': [{'name': 'Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel', 'type': 'DRUG', 'otherNames': ['HPGG'], 'armGroupLabels': ['HPGG 0.25%']}, {'name': 'Hydroxypropyl Guar Galactomannan Vehicle', 'type': 'DRUG', 'otherNames': ['HPGG Vehicle'], 'description': 'Inactive ingredients used as a placebo comparator', 'armGroupLabels': ['HPGG Vehicle']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jay H. Mashburn', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}