Recruiting

Oral Nutrition

Sponsor:

Eye and Vision Technologies and Research Institute

Code:

NCT01561040

Conditions

Dry Eye Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Omega 3, Vitamins A, D3 and E

Study Details

Brief summary:

Dry eye disease (DED) is a common but often inadequately treated disease of the tears and surface of the eye. It can cause poor vision and chronic pain and is more frequent with increasing age. The 1995 Report of the National Eye Institute/Industry Workshop on Clinical Trials in Dry Eye defined dry eye as "a disorder of the tear film due to tear deficiency or excessive evaporation, which causes damage to the interpalpebral ocular surface and is associated with symptoms of ocular discomfort". The International Dry Eye Work Shop (DEWS) committee subsequently defined dry eye as "a multi-factorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface." Typically, symptoms associated with dry eye disease include ocular burning, foreign body sensation (sand or grit), photophobia (light sensitivity), and other symptoms that result in overall long term discomfort in patients. The proposed eight week feasibility study if dry eye subjects confirmed elevated osmolarity and symptoms respond to nutritional therapy.

Conditions

Dry Eye Syndrome

Study ID

NCT01561040

Start date

Mar, 2012

Status verified date

Mar, 2012

Completion date

Dec, 2012

Anticipated

Primary completion date

Jun, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age 18 to 79 at the time of informed consent.
  • Must understand; be willing and able, and likely to fully comply with study procedures, visit schedule, and restrictions.
  • A diagnosis of dry eye disease based on a global clinical assessment by the attending clinician, patient complaint of dry eye symptoms and osmolarity. There will be two osmolarity tiers; the lower tier is an open label design based on an average osmolarity between 316-326 mOsmo/L, and the other a group >=327 mOsmol/L. (Enrollment in the two tiers can either be simultaneous, or the second tier can be included after a responder analysis is done of tier 1).

Exclusion Criteria:

  • 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 Visit 1 or at any time during the study.
  • Ophthalmologic drop use within 2 hours of any study visits.
  • Pregnancy or lactation at any time during the study by history.
  • Abnormality of nasolacrimal drainage (by history).
  • Punctal cauterization or current punctal plug placement or within 30 days of punctual plug removal.
  • Permissible Medications/Treatments- any commercially available OTC artificial tear.
  • Prohibited Medications- Cyclosporine; any topical prescription medications (i.e., steroids, NSAIDs, etc); glaucoma medications; oral tetracyclines or topical macrolides; oral nutraceuticals (flax, fish, black currant seed oils, etc...) within 3 weeks of baseline.

Started or changed 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 Visit 1.

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Omega 3, Vitamins A, D3 and E

Dry eye patients that have been screened with elevated osmolarity dispensed EZ Tears supplements containing Omega 3, Vitamins A, D3 and E to evaluate the change in dry eye conditions subjectively and objectively.

Interventions

Omega 3, Vitamins A, D3 and E

omega 3 1480 mg vitamin A 1,000 IU vitamin D3 2,000 IU vitamin E 60 IU

Primary outcome measure

  • Dry eye subjects ingesting omega three and the effect on seven diagnostic markers responding to omega 3 nutritional therapy. [ Time Frame: two months ]

Central Contacts and Locations

Central contacts

Locations

Scot Morris

Recruiting

Conifer, Colorado, United States, 80433

Contacts

Principal Investigator:

Scot Morris, O.D.

Davis EyeCare

Recruiting

Oak Lawn, Illinois, United States, 60453

Contacts

Principal Investigator:

Robert L Davis, O.D.

Koffler Vision Group

Recruiting

Lexington, Kentucky, United States, 40509

Contacts

Paul M. Karpecki, O.D.

800-998-2068

Principal Investigator:

Bruce Koffler, M.D.

Sean Mulqueeny OD

Recruiting

Creve Coeur, Missouri, United States, 63141

Contacts

Principal Investigator:

Sean Mulqueeny, O.D.

More Information

Sponsor

Eye and Vision Technologies and Research Institute

Last update posted

Mar 26, 2012

Last verified

Mar, 2012

Keywords

  • Dry Eye syndrome
  • tear film deficiency
  • Essential Fatty Acid nutritional supplements
  • Omega three supplements

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eye and Vision Technologies and Research Institute on 2012-03-26.