Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT02420834
Status:
COMPLETED
Last Update Posted:
2019-01-10
First Post:
2015-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dry Eye Treatment With Artificial Tears
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002266', 'term': 'Carboxymethylcellulose Sodium'}], 'ancestors': [{'id': 'D008747', 'term': 'Methylcellulose'}, {'id': 'D002482', 'term': 'Cellulose'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-09', 'studyFirstSubmitDate': '2015-04-10', 'studyFirstSubmitQcDate': '2015-04-15', 'lastUpdatePostDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptoms', 'timeFrame': '4 months', 'description': 'Short questionnaire (Ocular Surface Disease Index)'}], 'secondaryOutcomes': [{'measure': 'Non-invasive break-up time', 'timeFrame': '4 months', 'description': 'Tear stability will be assessed using the Purkinje reflection from the tear film on the ocular surface recording the time (in seconds) that the reflection is first distorted, observed with a slit lamp biomicroscope'}, {'measure': 'Tear meniscus height', 'timeFrame': '4 months', 'description': 'Tear meniscus height will be assessed in millimetres by comparing to the slit height adjustment of a slit lamp biomicroscope.'}, {'measure': 'lid parallel conjunctival folds', 'timeFrame': '4 months', 'description': 'Lid parallel conjunctival folds will counted as observed with a slit lamp biomicroscope and timed/graded'}, {'measure': 'Ocular Surface Staining', 'timeFrame': '4 months', 'description': 'Ocular surface staining with fluorescein and lissamine green dyes will be observed with a slitlamp biomicroscope and graded using the Efron grading scale'}, {'measure': 'Phenol Red Test', 'timeFrame': '4 months', 'description': 'Tear volume will be quantified in millimetres after 15s with the tip inserted in the lower tear meniscus from the wetting height of a phenol red impregnated strip inserted in the lower fornix for 15 seconds'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'Dry eye is a chronic irritating eye condition that affects many people, caused by poor tear quality and insufficient quantity. Treatments are traditionally in the form of artificial tears applied to the ocular surface. However, there is little evidence in the scientific literature that demonstrates their efficacy relative compared to each other, nor how to decide which one might be most effective for an individual patient. Therefore the investigators aim to examine the efficacy of different classes of artificial tears (those designed to increase viscosity, reduce evaporation or to mimic the component balance of the natural tears). In addition, the investigators also aim to determine how the treatment preferred by an individual could potentially have been predicted from their baseline condition.', 'detailedDescription': 'The efficacy of different classes of artificial tears (non-pharmaceutical) will be examined in patients that report dry eyes by prescribing each category of treatment \\[0.40% Sodium Hyaluronate (Clinitas Soothe), 0.15% Sodium Hyaluronate (Hyabak), 0.25% Carboxymethylcellulose, electrolyte balanced (Theratears), and Phospholipid liposomal spray (Tears Again)\\] for a month in turn following a short wash-out period and to examine their tear film and ocular surface after each one.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* subjective symptoms indicative of dry eye\n\nExclusion Criteria:\n\n* Diabetes\n* Sjögren's Syndrome\n* recent ocular infection\n* hay fever\n* used any eye drops or ocular medications,\n* were currently on medications known to affect the eyes\n* wore contact lenses\n* were pregnant."}, 'identificationModule': {'nctId': 'NCT02420834', 'briefTitle': 'Dry Eye Treatment With Artificial Tears', 'organization': {'class': 'OTHER', 'fullName': 'Aston University'}, 'officialTitle': 'Dry Eye Treatment With Artificial Tears', 'orgStudyIdInfo': {'id': 'DOptomEssa'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tear Supplement Hypromellose 0.15%', 'description': 'Preservative free Hypromellose Eye Drops BP 0.15% applied as required for 1 month', 'interventionNames': ['Other: Hypromellose 0.15%']}, {'type': 'EXPERIMENTAL', 'label': 'Tear Supplement Hypromellose 0.4%', 'description': 'Preservative free Hypromellose Eye Drops BP 0.4% applied as required for 1 month', 'interventionNames': ['Other: Hypromellose 0.4%']}, {'type': 'EXPERIMENTAL', 'label': 'Tear Supplement Carboxymethylcellulose', 'description': 'Tear Supplement 3: Preservative free 0.25% Carboxymethylcellulose, electrolyte balanced (Theratears) applied as required for 1 month', 'interventionNames': ['Other: Carboxymethylcellulose']}, {'type': 'EXPERIMENTAL', 'label': 'Tear Supplement Liposomal spray', 'description': 'Preservative free Phospholipid liposomal spray (Tears Again) applied as required for 1 month', 'interventionNames': ['Other: Liposomal Spray']}], 'interventions': [{'name': 'Hypromellose 0.15%', 'type': 'OTHER', 'otherNames': ['Hypromellose is also sold as Isopto plain eye drops'], 'description': 'Tear supplement to be taken as required to relieve symptoms', 'armGroupLabels': ['Tear Supplement Hypromellose 0.15%']}, {'name': 'Hypromellose 0.4%', 'type': 'OTHER', 'otherNames': ['Hypromellose is also sold as Isopto plain eye drops'], 'description': 'Tear supplement to be taken as required to relieve symptoms', 'armGroupLabels': ['Tear Supplement Hypromellose 0.4%']}, {'name': 'Carboxymethylcellulose', 'type': 'OTHER', 'otherNames': ['Theratears'], 'description': 'Tear supplement to be taken as required to relieve symptoms', 'armGroupLabels': ['Tear Supplement Carboxymethylcellulose']}, {'name': 'Liposomal Spray', 'type': 'OTHER', 'otherNames': ['Tears Again'], 'description': 'Tear supplement o be taken as required to relieve symptoms', 'armGroupLabels': ['Tear Supplement Liposomal spray']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'FY5 1AJ', 'city': 'Thornton', 'state': 'Cleveleys', 'country': 'United Kingdom', 'facility': 'Specsavers', 'geoPoint': {'lat': 56.16667, 'lon': -3.15}}], 'overallOfficials': [{'name': 'James S Wolffsohn, BSc PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aston University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aston University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}