Clinical trial NCT01630551: Omega 3 Supplementation and Ocular Surface Disease in Glaucoma
Official title: Omega-3 Fatty Acid Nutritional Supplementation in the Treatment of Ocular Surface Disease Associated With Intraocular Pressure-Lowering Medications
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ocular Surface Disease
Keywords: tears
dry eyes
ocular surface disease
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: American Glaucoma Society
First posted: 2012-06-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Omega 3 fatty acid
Primary purpose: TREATMENT

Brief summary: Ocular surface disease (OSD) is a significant health problem that affects more than 10 million persons in the United States alone. OSD is highly prevalent among medically treated patients with glaucoma and is associated with the number of intraocular pressure (IOP)-lowering medications used.

The purpose of this study is to determine the potential effectiveness of anoritega-3 fatty acid nutritional supplement in the treatment of ocular surface disease associated"with the use of glaucoma eye drops

Detailed description: Description of procedures/methods:

BASELINE VISIT Once the treating ophthalmologist has made the diagnosis of OSD, subjects will be asked to participate in the research study. Informed consent will be obtained for all subjects willing to participate in the study. Afterwards, the treating ophthalmologist will administer a dry eye questionnaire to each subject. After completion of the questionnaire, subjects will be given 90-day supply of the study drug/placebo. Based on a pre-determined randomization list, each subjects will be randomized to receive either the study medication (TheraTears nutritional supplementation) or a placebo drug (olive oil capsules). All subjects will be instructed to continue using artificial lubrication as needed while taking part in this study.

We hypothesize that therapy with an oral fish oil nutritional supplement containing 450mg EPA, 300 mg DHA, and 1000 mg flaxseed oil (TheraTears Nutrition; Advanced Vision Research, Woburn, MA) will decrease OSD-related symptoms as well as clinical markers associated with OSD (Schirmer test values, positive vital staining with lissamine green, fluorescein tear break-up time, and tear film osmolarity) when compared to administration of placebo.

FOLLOW-UP VISIT Approximately 90 days after the baseline visit, subjects are scheduled to come to the clinic for their routine• eye check. At that visit, subject's O.SD will be re-assessed by the same examination techniques as the baseline visit. After the examination, the questionnaire will be administered for a second time. The study drug will be discontinued at that visit and standard therapy for the subject's OSO, as deemed necessary by the treating ophthalmologist, will be instituted.

Statement of duration of subject participation:

Subject will be in the study for 3 months. There will be two visits, one is the baseline and second is the follow-up visit. All visits will coincide with their regular clinic visit. The total hours of study participation is no more than 2 hours.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Typical symptoms of dry eye (photophobia, burning, foreign body sensation, blurred vision improved with blinking)
* OSDI score \> 12
* Schirmer Test with Anesthesia \< 8 mm/5 minutes
* Fluorescein tear break-up time \< 8 seconds
* No current use of dry eye treatment (except artificial lubrication)

Exclusion Criteria:

* Infectious keratoconjunctivitis or inflammatory disease unrelated to dry eye or topical glaucoma medication use
* Patients with severe tear deficiency (defined as Schirmer tes \<5 mm/5 min)
* Concomitant ocular pathology
* History of ocular surgery
* Eyelid or eyelash abnormalities
* Alteration of the nasolacrimal apparatus
* Treatment with drugs affecting tearing
* Treatment with vitamin supplements
* Concomitant ocular therapies
* Topical ophthalmic steroids taken during the 4 weeks before the study
* Pregnant/breast-feeding women
* Women who may be pregnant at the baseline visit or may become pregnant during the 90 days of therapy
* Diabetes
* History of fish and/or shellfish allergy or hypersensitivity

Primary outcomes:
measure: Ocular Surface Disease Index Score
timeFrame: 90 Days
Secondary outcomes:
measure: Schirmer test score
timeFrame: 90 days
measure: Lissamine Green Staining Score
timeFrame: 90 Days
measure: Fluorescein tear break-up time
timeFrame: 90 Days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Glaucoma Service, Department of Ophthalmology and Visual Science
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago College of Medicine
name: Ahmad A Aref, MD
role: PRINCIPAL_INVESTIGATOR
References: