The Influence of PRN Dry Eye Omega-3 Nutritional Regimen on Tear Osmolarity In Cases Of Dry Eye Disease

Dry Eye Disease Clinical Trial

Official title:

The Influence of PRN Dry Eye Omega-3 Nutritional Regimen on Tear Osmolarity In Cases Of Dry Eye Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02260960
• Other study ID #: PRN 20142
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 6, 2014
• Last updated: August 2, 2016
• Start date: March 2014
• Est. completion date: March 2015

Study information

• Verified date: August 2016
• Source: Physician Recommended Nutriceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesize that oral omega-3-acid triglyceride form will decrease dry-eye related symptoms as well as clinical markers associated with dry eye disease (TearOsmolarity, Schirmer-1 test values, corneal staining, and fluorescein tear break-up time) when compared to administration of placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age =18 and = 90 at the time of informed consent

• Subjects experiencing dry eye based on a global clinical assessment by the attending clinician, subject complaint of dry eye symptoms

• Presence or History of Tear Osmolarity (Appendix 2) equal to or greater than 312 mOsm/L in at least one eye

• Presence or History of Meibomian Gland Dysfunction (Grade 1 or 2) in at least one eye

Exclusion Criteria:

• Allergy to fish oil or safflower oil

• Clinically significant eyelid deformity or eyelid movement disorder that is caused by conditions such as notch deformity, incomplete lid closure, entropion, ectropion, hordeola or chalazia

• Previous ocular disease leaving sequelae or requiring current topical eye therapy other than for DED, including, but not limited to: active corneal or conjunctival infection of the eye and ocular surface scarring Active ocular or nasal allergy

• LASIK or PRK surgery that was performed within one year of the Screening Visit or at any time during the study

• Ophthalmologic drop use within 2 hours of any study visits. Any OTC habitual artificial tear should be continued at the same frequency and no change in drop brand

• Contact lens wear within 12 hours of any study visits

• Pregnancy or lactation during the study

• Abnormal nasolacrimal drainage (by history)

• Punctal cauterization or punctal plug placement within 60 days of screening

• Prohibited Medications - Cyclosporine (Restasis®); any topical prescription medications (i.e., steroids, NSAIDs, etc); glaucoma medications; oral tetracyclines or topical macrolides; oral nutraceuticals (flax, black currant seed oils, etc…) within 3 weeks (21 days) of Screening and at any time during the study

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Dietary Supplement:
• Omega-3 (Triglyceride form)

Locations

Country	Name	City	State
United States	The Eye Center of Columbus	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Physician Recommended Nutriceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear Osmolarity		12 weeks	No