Dry Eye Assessment and Management: Feasibility Study

NCT01102257 | Completed Phase 2 Results DMC

• 2 other identifiers: 05-10991R34EY017626
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test a protocol investigating the efficacy of omega-3 fatty acids in treating dry eye disease. The study is termed "feasibility" because its purpose is to demonstrate an ability to execute the proposed protocol with compliance at two sites rather than generate statistically relevant data concerning the safety and efficacy of the supplement in patients with dry eye disease.

Conditions

Dry Eye Syndromes; Keratoconjunctivitis Sicca

Keywords

Dry Eye Disease; DED; Keratoconjunctivitis Sicca; Omega-3

Outcome Measures

Primary Outcomes (2)

• Change on Ocular Surface Disease Index (OSDI)

  90 +/- 14 days following initiation of drug regimen

• Change in REd Blood Cell(RBC) Membrane Fatty Acid(FA) Content

  Baseline and 3 Months

Secondary Outcomes (6)

• Change on Brief Ocular Discomfort Inventory (BODI)

  90 +/- 14 days following initiation of drug regimen

• Change on Impact of Dry Eye on Everyday Life (IDEEL)

  90 +/- 14 days following initiation of drug regimen

• Change in Quality of Life Associated With Chronic Pain

  90 +/- 14 days following initiation of drug regimen

• Change in the Ocular Surface

  90 +/- 14 days following initiation of drug regimen

• Change in Schirmer's

  90 +/- 14 days following initiation of drug regimen

Study Arms (2)

Omega-3 EFA Supplement

EXPERIMENTAL

The total daily dose from the 5 capsules in treatment group will be 3.0 grams of omega-3 esssential fatty acid i.e Omega-3 EFA supplement comprised of: 2000 mg EPA 1000 mg DHA

Drug: Omega-3 EFA Supplement

Olive Oil

PLACEBO COMPARATOR

Gel Capsule

Drug: Olive Oil

Interventions

Omega-3 EFA Supplement DRUG

The total daily dose from the 5 capsules in treatment group will be 3.0 grams of omega-3 EFAs comprised of: 2000 mg EPA 1000 mg DHA

Also known as: Fish oil supplements

Omega-3 EFA Supplement

Olive Oil DRUG

Placebo group will take 5 capsules a day containing 3.0 grams of olive oil

Olive Oil

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign and date the informed consent form approved by the IRB.
• ≥ 18 years of age
• Demonstrate at least 2 of the 4 following signs in the same eye at two consecutive visits (Visit 1: 7 - 21 days prior to randomization, and Visit 2: day of randomization).
• Conjunctival staining present ≥ 1
• Corneal fluorescein staining present ≥ 1
• Tear film break up time (TFBUT) ≤ 7 seconds
• Schirmer test ≤ 7 mm/5min
• Demonstrate symptoms of dry eye disease (OSDI score of at least 22 at screening visit and at least 15 at randomization visit).
• Use or desire to use artificial tears on average of 2 times per day in the 2 weeks preceding study entry (run in period). No newly diagnosed patients can be enrolled and if a new patient wants to participate, she/he must be put on tears and re-evaluated in 6 months.
• Intraocular pressure (IOP) ≥ 5 mmHg and ≤ 22 mmHg in each eye.
• Women of child-bearing potential must agree to use a reliable method of contraception during study participation, and must demonstrate a negative urine pregnancy test at screening visit.
• Be willing/able to return for all study visits and to follow instructions from the study investigator and his/her staff.
• Be able to swallow large, soft gelcaps

You may not qualify if:

• Patients who are allergic to ingredients of the active or placebo pills (fish, olive oil).
• Current diagnosis of ocular infection (e.g. bacterial, viral or fungal).
• History of ocular herpetic keratitis.
• Eye surgery (including cataract surgery) within 6 months prior to randomization.
• Previous LASIK surgery
• Pregnant or nursing/lactating
• Participation in a study of an investigational drug or device within the past 30 days.
• Recent (≤ 3 months) initiation of use of systemic corticosteroids or other immunosuppressive agent and/or is planning to change treatment during study participation
• Cognitive or psychiatric deficit that precludes informed consent or ability to perform requirements of the investigation.
• Contact lens wearers
• Use of glaucoma medication or history of surgery for glaucoma.
• Recent (≤ 3 months) insertion of punctual plugs.
• Using punctual plugs but unwilling to commit to their use for the duration of the study.
• Unwilling to commit to same brand of artificial tears throughout the study.
• Current use of EPA/DHA supplements in excess of 1 gram/day.

Sponsors & Collaborators

• Asbell, Penny, M.D.: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Keratoconjunctivitis Sicca

Interventions

Olive Oil

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Limitations and Caveats

DREAM: Feasibility Study, is labeled "feasibility" because its primary end-point is to demonstrate an ability to execute the protocol rather than generate statistically relevant data on the safety and efficacy of omega-3 EFA in patients with DED.

Results Point of Contact

• Title: Dr. Penny Asbell
• Organization: Mount Sinai School of Medicine

penny.asbell@mssm.edu

(212) 241-7977

Study Officials

• Penny Asbell, • MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 9, 2010
• First Posted: April 13, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: March 1, 2011
• Last Updated: August 23, 2012
• Results First Posted: August 23, 2012

Record last verified: 2012-07

Locations

US (1)