Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-04 @ 9:33 PM
Study NCT ID:
NCT03525704
Status:
COMPLETED
Last Update Posted:
2021-01-27
First Post:
2018-03-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Contact Lens Saline Solutions With Scleral GP Contact Lens Wearers Experiencing Fogging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Randomized, Double-Masked'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'One-month, approximately 36 subjects enrolled (\\~12/site), randomized, double-masked crossover trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2018-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-25', 'studyFirstSubmitDate': '2018-03-30', 'studyFirstSubmitQcDate': '2018-05-03', 'lastUpdatePostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Subjective Symptoms and Wear Time Survey', 'timeFrame': '1 Month', 'description': 'Participant Survey on Lens Comfort (based on a scale of 0 to 5), Symptoms (graded based on frequency (rarely/sometimes/often/always) and severity(slight/moderate/severe)), Total Wear Time (reported as hours per day) and How Many Times Lenses are Removed Daily (reported as number of times per day)'}], 'secondaryOutcomes': [{'measure': 'Biomicroscopy Findings', 'timeFrame': '1 Month', 'description': 'Edema, Bulbar Redness, Limbal Redness, Corneal Vascularization, Corneal Infiltrates, Palpebral Conjunctival Observations and Corneal Staining are evaluated on a grading scale of 0 to 4.'}, {'measure': 'Visual Acuity', 'timeFrame': '1 Month', 'description': 'Visual acuity (in units of Logmar) is evaluated with subject wearing habitual contact lenses.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Fogging', 'Insertion Solutions', 'RGP', 'Scleral', 'Contact Lenses'], 'conditions': ['Contact Lens Complication', 'Debris in Post Lens Tear Reservoir']}, 'descriptionModule': {'briefSummary': 'Evaluation of saline solutions used with scleral rigid gas permeable contact lens wearers experiencing debris in the post lens tear reservoir', 'detailedDescription': 'One-month, approximately 36 subjects enrolled (\\~12/site), randomized, double-masked crossover trial.\n\nExisting scleral rigid gas permeable (RGP) contact lens wearing subjects are randomly assigned (block) to different arms of the trial and receive different saline solutions for use sequentially for 2-week periods. The subjects will continue to wear their existing scleral GP lenses if lens fit is acceptable following an initial evaluation. Subjects will agree to complete a survey administered daily (via email) that will address contact lens wear time and subjective symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:•\n\n* Daily wear large diameter (scleral) rigid gas permeable contact lens wearers in design with acceptable fit\n* 18 years old or above.\n* Agree to and sign Informed Consent.\n* Correctable to at least 20/40 distance visual acuity in each eye.\n* Presence of debris or "fogging" in post lens tear film reservoir (PLTR).\n\nExclusion Criteria:\n\n* Extended wear contact lens wearers\n* Require concurrent ocular medication.\n* Grade 2 or more slit lamp findings (does not include fogging assessment).\n* Eye injury or surgery within twelve weeks immediately prior to enrolment for this trial.\n* Currently enrolled in an ophthalmic clinical trial.\n* Pregnant or lactating\n* Evidence of active ophthalmic disease or abnormality including glaucoma, chorioretinitis, central retinal artery or vein occlusion, intraocular or ocular infection.'}, 'identificationModule': {'nctId': 'NCT03525704', 'briefTitle': 'Evaluation of Contact Lens Saline Solutions With Scleral GP Contact Lens Wearers Experiencing Fogging', 'organization': {'class': 'INDUSTRY', 'fullName': 'Contamac Ltd'}, 'officialTitle': 'Evaluation of Contact Lens Saline Solutions With Scleral GP Contact Lens Wearers Experiencing Fogging', 'orgStudyIdInfo': {'id': 'AVDR 2018-01 v1.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Saline Solution Enriched', 'description': 'Saline Solution enriched with electrolytes and PH balanced to mimic normal tears', 'interventionNames': ['Device: Saline Solution Enriched']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Saline Rinse Solution', 'description': 'Saline Solution .9% NaCL', 'interventionNames': ['Device: Saline Rinse Solution']}], 'interventions': [{'name': 'Saline Solution Enriched', 'type': 'DEVICE', 'otherNames': ['NutriFill', 'GatorFill'], 'description': 'Sterile single dose, Preservative Free, PH Balanced, Enriched with IONs rinsing and Insertion Solution', 'armGroupLabels': ['Saline Solution Enriched']}, {'name': 'Saline Rinse Solution', 'type': 'DEVICE', 'otherNames': ['LacriPure', 'ScleralFil'], 'description': 'sterile unit dose non-preserved, 0.9% NaCl (normal saline) solution i', 'armGroupLabels': ['Saline Rinse Solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97068', 'city': 'West Linn', 'state': 'Oregon', 'country': 'United States', 'facility': 'Andre Vision and Device Research', 'geoPoint': {'lat': 45.36568, 'lon': -122.61231}}], 'overallOfficials': [{'name': 'Bret Andre, MS, ABOe', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AVD Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Contamac Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Andre Vision and Device Research', 'class': 'UNKNOWN'}, {'name': 'The Contact Lens Center at Optique', 'class': 'UNKNOWN'}, {'name': 'Premiere Vision Group', 'class': 'UNKNOWN'}, {'name': 'Havasu Eye Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}