Efficacy and Safety Study of Nutritional Supplements for Treatments of Dry Eye

A Randomized, Parallel-Group, Placebo-Control, Double-Blind Trial Comparing the Efficacy and Safety of Nutritional Supplementation Containing Omega 3 Fatty Acids and Gamma Linoleic Acid, for Treatment of Keratoconjunctivitis Sicca in Post-Menopausal Females

The purpose of this study is to determine the effectiveness of a nutritional supplement in post-menopausal women age 40 or older with moderate to severe dry eyes. This study is being conducted to determine if signs and symptoms of dry eye will improve with the use of this nutritional supplement.

Study Overview

• Status: Completed
• Conditions: Keratoconjunctivitis Sicca
• Intervention / Treatment: Other: Inactive Capsule; Dietary supplement: Hydroeye

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Eye Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Signature on the written informed consent form
• Patient motivation and willingness to cooperate with the investigator by following the required medication regimen
• Patient willingness and ability to return for all visits during the study
• Rapid tear film break up time of eight seconds or less in at least one eye AND/OR
• Signs of meibomian gland dysfunction (MGD) including at least grade one lid notching, or the presence of orifice pustules
• At least grade one fluorescein superficial punctate keratitis (SPK) in at least one corneal quadrant or at least grade one conjunctival lissamine green staining in at least one eye.
• Ocular Surface Disease Index score of sixteen or greater.
• Willing to discontinue use of any current dry eye treatment (except artificial tears) for four weeks prior to randomization, and during the course of the six month study
• Post-menopausal women aged 40 years old or above. Post menopause is defined as absence of menstrual period for at least one year, or surgical hysterectomy with bilateral oophorectomy no less than six months prior
• If using transdermal, vaginal or systemic estrogen, progesterone, or estrogen derivatives, must be on a stable dose for at least 90 days, and be planning on staying on same stable dose for duration of the study

Exclusion Criteria:

• Concurrent involvement in any other clinical trial involving an investigational drug or device
• Compromised cognitive ability which may be expected to interfere with study compliance
• Uncontrolled or poorly controlled systemic disease (e.g., hypertension, diabetes) or the presence of any significant illness (e.g., serious gastrointestinal, renal, hepatic, endocrine, pulmonary, cardiac, neurological disease, cancer, AIDS, or cerebral dysfunction) that could, in the judgment of the investigator, jeopardize subject safety or interfere with the interpretation of the results of the study
• Known hypersensitivity to any components of the study or procedural medication
• Anticipated contact lens wear during the study
• History of corneal transplant
• Active ocular infection, uveitis or non-KCS inflammation
• History of recurrent herpes keratitis or active disease within the last six months
• History of cataract surgery within 3 months prior to enrollment
• History of ocular surface surgery (i.e. refractive, lasik, pterygium) within 6 months prior to enrollment
• corneal disorder or abnormality that affects corneal sensitivity or normal spreading of the tear film [except superficial punctate keratitis (SPK)]
• Use of systemic cyclosporine within prior 3 months
• Initiation, discontinuation or change in dosage of antihistamines, cholinergic agents, beta-blocking agents, tricyclic or SSRI antidepressants, phenothiazines, or topical or systemic acne rosacea medications in two months prior to enrollment, or anticipated change in dosage during course of study
• Topical ophthalmic medications within prior 4 weeks, or anticipated use of same during the study (except artificial tears)
• Use of Coumadin or Plavix within prior 2 weeks, or anticipated use of same during study. Stable dosing of aspirin 325mg or 85 mg per day is permitted.
• Use of fish oil, borage, evening primrose, flaxseed or black current seed oil supplements in the past three months
• Routine, usual dietary intake of more than 12 ounces of cold water fatty fish (tuna, salmon, mackerel, sea bass, sardines or herring) per week
• Occlusion of the lacrimal puncta either surgically or with temporary collagen punctal plugs within one month prior to study, or anticipated use of same during study
• A patient condition or situation which, in the judgment of the investigator, may put the patient at a significant risk, may confound the study results, or may interfere with the patient's participation in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2	Dietary supplement: Hydroeye; 2 Capsules BID
Placebo Comparator: 1	Other: Inactive Capsule; 2 Capsules BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Schirmer tear test	Screening, Week 4, Week 12, Week 24
Ocular Surface Disease Index	Screening, Week 4, Week 12, Week 24
Tear Breakup Time	Screening, Week 4, Week 12, Week 24
Corneal Staining with Fluorescein	Screening, Week 4, Week 12, Week 24
Impression Cytology	Screening, Week 12, Week 24
Conjunctival staining with lissamine	Screening, Week 4, Week 12, Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Corneal Topography	Screening, Week 4, Week 12, Week 24
Meibomian Gland Dysfunction	Screening, Week 4, Week 12, Week 24
Facial Expression Subjective Scale	Screening, Week 4, Week 12, Week 24
Frequency of Artificial Tear Usage	Screening, Week 4, Week 12, Week 24
HLA-DR Staining of Impression Cytology	Screening, Week 12, Week 24

Collaborators and Investigators

• Sponsor: Virginia Eye Consultants
• Collaborators: Baylor College of Medicine; ScienceBased Health
• Investigators: Principal Investigator: John D Sheppard, M.D., Virginia Eye Consultants; Principal Investigator: Stephen C Pflugfelder, M.D., Baylor College of Medicine; Study Chair: Joe Wakil, M.D., ScienceBased Health; Study Chair: Penelope Edwards, MPH, CNS, ScienceBased Health

Publications and helpful links

General Publications

• Sheppard JD Jr, Singh R, McClellan AJ, Weikert MP, Scoper SV, Joly TJ, Whitley WO, Kakkar E, Pflugfelder SC. Long-term Supplementation With n-6 and n-3 PUFAs Improves Moderate-to-Severe Keratoconjunctivitis Sicca: A Randomized Double-Blind Clinical Trial. Cornea. 2013 Oct;32(10):1297-304. doi: 10.1097/ICO.0b013e318299549c.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: April 17, 2009
• First Submitted That Met QC Criteria: April 17, 2009
• First Posted (Estimate): April 20, 2009

Study Record Updates

• Last Update Posted (Estimate): February 20, 2012
• Last Update Submitted That Met QC Criteria: February 16, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Post-menopausal; Dry Eyes; Keratoconjunctivitis Sicca
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Keratoconjunctivitis
• Other Study ID Numbers: SBH2005-01