The Influence of PRN Omega-3 Nutritional Supplement on Visual Acuity
Primary Purpose
Cataract, Dry Eye Disease
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Omega-3 (Triglyceride form)
Sponsored by
About this trial
This is an interventional supportive care trial for Cataract, Dry Eye Disease
Eligibility Criteria
Inclusion Criteria:
- Presence of nuclear or cortical lens opacities in one/both eyes
- Physician diagnosis of age related cataract
- Good overall physical constitution
- All participants must be follow the same regimen for surgery related medications, both pre and post surgery. (Antibiotic, NSAID and Steroid eye drops)
Exclusion Criteria:
- Subjects requiring Premium IOLs/multifocal implants
- Advanced cataract
- Severe Age-Related Macular Degeneration Presence or history of Glaucoma
- Presence or history of Diabetes Mellitus
- Any Retinal pathology - retinal detachment, retinitis pigmentosa, diabetic retinopathy, etc
- Vision loss due to Central retinal artery occlusion or Central retinal vein occlusion
- Vision loss due to presence of large pituitary tumors or aneurysms
- Vision loss due to optic tract lesions
- Vision loss due to bleeding into aqueous or vitreous chamber
- Vision loss due to drug toxicity: Amiodarone, anti-tuberculosis drugs, hydroxychloroquine, tamoxifen
- Major cardiovascular or cerebral events in the past 12 months
- Allergy to fish oil or safflower oil
- Pregnancy or lactation at any time during the study
- Newly started or increased the dose of chronic systemic medication known to affect tear production including, but not limited to antihistamines, antidepressants, diuretics, corticosteroids or immunomodulators within 30 days of Screening or at any time during the study
- Participation in any other study involving an investigational drug or device within the past 30 days
Sites / Locations
- Cincinnati Eye InstituteRecruiting
- Southern Eye AssociatesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Omega-3
Safflower Oil
Arm Description
re esterified TG omega-3
vegetable oil
Outcomes
Primary Outcome Measures
Visual Acuity
Secondary Outcome Measures
Full Information
NCT ID
NCT02260973
First Posted
October 6, 2014
Last Updated
August 2, 2016
Sponsor
Physician Recommended Nutriceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02260973
Brief Title
The Influence of PRN Omega-3 Nutritional Supplement on Visual Acuity
Official Title
The Influence of PRN Omega-3 Nutritional Supplement on Visual Acuity Outcomes In Cases Undergoing Cataract Surgery: A Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Physician Recommended Nutriceuticals
4. Oversight
5. Study Description
Brief Summary
This is a randomized, masked, placebo controlled study to assess the effect on visual acuity, if any, of the PRN omega-3 nutritional supplement in subjects undergoing cataract surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Dry Eye Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Omega-3
Arm Type
Active Comparator
Arm Description
re esterified TG omega-3
Arm Title
Safflower Oil
Arm Type
Placebo Comparator
Arm Description
vegetable oil
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 (Triglyceride form)
Primary Outcome Measure Information:
Title
Visual Acuity
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presence of nuclear or cortical lens opacities in one/both eyes
Physician diagnosis of age related cataract
Good overall physical constitution
All participants must be follow the same regimen for surgery related medications, both pre and post surgery. (Antibiotic, NSAID and Steroid eye drops)
Exclusion Criteria:
Subjects requiring Premium IOLs/multifocal implants
Advanced cataract
Severe Age-Related Macular Degeneration Presence or history of Glaucoma
Presence or history of Diabetes Mellitus
Any Retinal pathology - retinal detachment, retinitis pigmentosa, diabetic retinopathy, etc
Vision loss due to Central retinal artery occlusion or Central retinal vein occlusion
Vision loss due to presence of large pituitary tumors or aneurysms
Vision loss due to optic tract lesions
Vision loss due to bleeding into aqueous or vitreous chamber
Vision loss due to drug toxicity: Amiodarone, anti-tuberculosis drugs, hydroxychloroquine, tamoxifen
Major cardiovascular or cerebral events in the past 12 months
Allergy to fish oil or safflower oil
Pregnancy or lactation at any time during the study
Newly started or increased the dose of chronic systemic medication known to affect tear production including, but not limited to antihistamines, antidepressants, diuretics, corticosteroids or immunomodulators within 30 days of Screening or at any time during the study
Participation in any other study involving an investigational drug or device within the past 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley Williams, MD
Organizational Affiliation
Southern Eye Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Eye Institute
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Crabtree
Phone
859-331-9000
Ext
4120
Facility Name
Southern Eye Associates
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Williams
Email
kim.williams@innovativeclinicalresearch.net
12. IPD Sharing Statement
Learn more about this trial
The Influence of PRN Omega-3 Nutritional Supplement on Visual Acuity
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