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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Keratoconjunctivitis Sicca	Dietary Supplement: Hydroeye; Other: Inactive Capsule	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	62 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	September 2008
Actual Primary Completion Date :	December 2011

Arms and Interventions

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Arm	Intervention/treatment
Placebo Comparator: 1	Other: Inactive Capsule; 2 Capsules BID
Active Comparator: 2	Dietary Supplement: Hydroeye; 2 Capsules BID

Outcome Measures

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Primary Outcome Measures :

1. Schirmer tear test [ Time Frame: Screening, Week 4, Week 12, Week 24 ]
2. Ocular Surface Disease Index [ Time Frame: Screening, Week 4, Week 12, Week 24 ]
3. Tear Breakup Time [ Time Frame: Screening, Week 4, Week 12, Week 24 ]
4. Corneal Staining with Fluorescein [ Time Frame: Screening, Week 4, Week 12, Week 24 ]
5. Impression Cytology [ Time Frame: Screening, Week 12, Week 24 ]
6. Conjunctival staining with lissamine [ Time Frame: Screening, Week 4, Week 12, Week 24 ]

Secondary Outcome Measures :

1. Corneal Topography [ Time Frame: Screening, Week 4, Week 12, Week 24 ]
2. Meibomian Gland Dysfunction [ Time Frame: Screening, Week 4, Week 12, Week 24 ]
3. Facial Expression Subjective Scale [ Time Frame: Screening, Week 4, Week 12, Week 24 ]
4. Frequency of Artificial Tear Usage [ Time Frame: Screening, Week 4, Week 12, Week 24 ]
5. HLA-DR Staining of Impression Cytology [ Time Frame: Screening, Week 12, Week 24 ]

Eligibility Criteria

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Ages Eligible for Study:	40 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Virginia Eye Consultants

ScienceBased Health

Baylor College of Medicine

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Virginia Eye Consultants
ClinicalTrials.gov Identifier:	NCT00883649 History of Changes
Other Study ID Numbers:	SBH2005-01
First Posted:	April 20, 2009
Last Update Posted:	February 20, 2012
Last Verified:	February 2012

Keywords provided by Virginia Eye Consultants:

Keratoconjunctivitis Sicca; Dry Eyes; Post-menopausal

Additional relevant MeSH terms:

Keratoconjunctivitis; Keratoconjunctivitis Sicca; Dry Eye Syndromes; Conjunctivitis; Conjunctival Diseases	Eye Diseases; Keratitis; Corneal Diseases; Lacrimal Apparatus Diseases