Clinical TrialID 434

Effect of an Oral Supplement Containing Omega-3 and Omega-6 on Dry Eye Symptoms

NCT03265327

Dry Eye

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Record Fields

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Clinical Trial Id
434
Evidence Id
434
Core Evidence Id
434
Source Clinical Trial Id
420
Herb2 Clinical Trial Id
HBCT000420
Nct Id
NCT03265327
Title
Effect of an Oral Supplement Containing Omega-3 and Omega-6 on Dry Eye Symptoms
Status
Completed
Phase
Study Result
No
Study Condition
Dry Eye
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Intervention
DIETARY_SUPPLEMENT: Oral supplement containing omega-3 and omega-6|DIETARY_SUPPLEMENT: Oral supplement containing coconut and olive oil
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Double
Intervention Purpose
Treatment
Gender
All
Age
Adult, Older_Adult
Enrollment
63
Outcome Measure
Ocular Surface Disease Index (OSDI) score, The OSDI is assessed on a scale of 0 and 100. A higher composite score indicates more severe dryness., At screening|Ocular Surface Disease Index (OSDI) score, The OSDI is assessed on a scale of 0 and 100. A higher composite score indicates more severe dryness., At 1 month|Ocular Surface Disease Index (OSDI) score, The OSDI is assessed on a scale of 0 and 100. A higher composite score indicates more severe dryness., At 3 months|Symptom Assessment in Dry Eye (SANDE) questionnaire, The Symptom Assessment in Dry Eye (SANDE) questionnaire is a dry eye questionnaire that asks participants to describe the frequency and severity of their dry eye symptoms using a visual analogue scale., At screening|Symptom Assessment in Dry Eye (SANDE) questionnaire, The Symptom Assessment in Dry Eye (SANDE) questionnaire is a dry eye questionnaire that asks participants to describe the frequency and severity of their dry eye symptoms using a visual analogue scale., At 1 month|Symptom Assessment in Dry Eye (SANDE) questionnaire, The Symptom Assessment in Dry Eye (SANDE) questionnaire is a dry eye questionnaire that asks participants to describe the frequency and severity of their dry eye symptoms using a visual analogue scale., At 3 months|Schirmers test, The small strip of paper is removed from the Schirmer test package, folded at one end, and is inserted into the outer corner of the participant's eyes. The participant is asked to close their eyes and wait for 5 minutes. After 5 minutes, the paper is removed and the length of which the paper strip is wetted is recorded in mm., At screening|Schirmers test, The small strip of paper is removed from the Schirmer test package, folded at one end, and is inserted into the outer corner of the participant's eyes. The participant is asked to close their eyes and wait for 5 minutes. After 5 minutes, the paper is removed and the length of which the paper strip is wetted is recorded in mm., At 1 month|Schirmers test, The small strip of paper is removed from the Schirmer test package, folded at one end, and is inserted into the outer corner of the participant's eyes. The participant is asked to close their eyes and wait for 5 minutes. After 5 minutes, the paper is removed and the length of which the paper strip is wetted is recorded in mm., At 3 months|Objective non-invasive tear film stability (NIKBUT), Time taken for tear film breakup as measured objectively in seconds., At screening|Objective non-invasive tear film stability (NIKBUT), Time taken for tear film breakup as measured objectively in seconds., At 1 month|Objective non-invasive tear film stability (NIKBUT), Time taken for tear film breakup as measured objectively in seconds., At 3 months|Non-invasive tear break up time (NITBUT), Time taken for tear film breakup as measured by a study investigator in seconds., At screening|Non-invasive tear break up time (NITBUT), Time taken for tear film breakup as measured by a study investigator in seconds., At 1 month|Non-invasive tear break up time (NITBUT), Time taken for tear film breakup as measured by a study investigator in seconds., At 3 months
Sponsor Collaborator
Nature's Way Canada|Centre for Contact Lens Research
Funded By
INDUSTRY
Location
Centre for Contact Lens Research, Waterloo, Ontario, N2L 3G1, Canada
Other Id
22309
Start Date
2017-08-16
Primary Completion Date
2018-06-27
Completion Date
2018-06-27
First Posted
2017-08-29
Results First Posted
Last Update Posted
2021-04-29
Study Document
Study Url
https://clinicaltrials.gov/study/NCT03265327
Title Cn
Title En
Effect of an Oral Supplement Containing Omega-3 and Omega-6 on Dry Eye Symptoms
Bilingual Status
semi_complete