A Placebo Controlled Double Masked Clinical Assessment Study of Essential Fatty Acid Supplement and Its Effect on Patients With Apparent Aqueous Deficient Dry Eye Syndrome

• Status: Unknown status
• Trial end date: 0000-00-00
• Target enrollment: 36
• Participant gender: Both

Summary

To determine the effect of Essential Fatty Acids (EFA’s) on Meibomian Gland lipids and aqueous tear production in patients with “dry eyes”.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: Advanced Vision Research
• Last Updated: 2006-06-23

Criteria

Inclusion Criteria: Patient over 18 years of age, patient willing and able to comply with the protocol, no planned changes in diet, topical or systemic drugs during course of study. Ocular symptoms consistent with dry eye of insidious onset and greater than three months duration. Ocular surface vital staining consistent with aqueous deficient dry eyes with less than +1 conjunctival injection and no more than minimal lid inflammation -

Exclusion Criteria: Any patient that uses topical eye drops other than artificial tears. Any patient with punctual occlusion or punctual plugs. Patients with active ocular infection or inflammatory disease, history of herpetic keratitis, history of retinal detachment, concurrent contact lens use during the trial period, ocular surgery within the past six months, patients with glaucoma, anterior membrane dystrophy, active trichiasis or any eyelid globe malposition abnormality, e.g., entropion, ectropion, etc. Patients with Epiphora (excessive tearing). Moreover, patients taking medications known to effect aqueous tear production or meibomian secretions. Patient must not have participated in (or be currently participating in) any investigational therapeutic drug or device trial within the previous 30 days prior to their start date for this trial. In addition, any patient suffering from organic brain syndromes or major psychiatric disorder that would interfere with compliance or subjective reporting will be discouraged from participating in this trial.