Recruiting
Phase 2
Phase 3

Omega-3

Sponsor:

Physician Recommended Nutriceuticals

Code:

NCT02260973

Conditions

Cataract, Dry Eye Disease

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Omega-3 (Triglyceride form)

Study Details

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.

Conditions

Cataract, Dry Eye Disease

Study ID

NCT02260973

Start date

Nov, 2014

Status verified date

Aug, 2016

Completion date

Dec, 2016

Anticipated

Primary completion date

Oct, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Omega-3

re esterified TG omega-3

placebo comparator: Safflower Oil

vegetable oil

Interventions

Omega-3 (Triglyceride form)

Primary outcome measure

  • Visual Acuity [ Time Frame: 8 weeks ]

Central Contacts and Locations

Locations

Cincinnati Eye Institute

Recruiting

Lexington, Kentucky, United States, 41017

Contacts

Rachel Crabtree

859-331-9000

Southern Eye Associates

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Kim Williams

kim.williams@innovativeclinicalresearch.net

More Information

Sponsor

Physician Recommended Nutriceuticals

Last update posted

Aug 4, 2016

Last verified

Aug, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Physician Recommended Nutriceuticals on 2016-08-04.