The Influence of PRN Omega-3 Nutritional Supplement on Visual Acuity

Physician Recommended Nutriceuticals

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Cataract, Dry Eye Disease

Treatments: Dietary Supplement: Omega-3 (Triglyceride form)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02260973

PRN 20145

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 30 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Omega-3

Active Comparator group

Description:

re esterified TG omega-3

Treatment:

Dietary Supplement: Omega-3 (Triglyceride form)

Safflower Oil

Placebo Comparator group

Description:

vegetable oil

Treatment:

Dietary Supplement: Omega-3 (Triglyceride form)