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

Keratoconjunctivitis Sicca Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00883649
• Other study ID #: SBH2005-01
• Status: Completed
• Phase: N/A
• First received: April 17, 2009
• Last updated: February 16, 2012
• Start date: September 2008

Study information

• Verified date: February 2012
• Source: Virginia Eye Consultants
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca

Intervention

Dietary Supplement:
• Hydroeye
2 Capsules BID

Other:
• Inactive Capsule
2 Capsules BID

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas
United States	Virginia Eye Consultants	Norfolk	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Virginia Eye Consultants	Baylor College of Medicine, ScienceBased Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Schirmer tear test		Screening, Week 4, Week 12, Week 24	No
Primary	Ocular Surface Disease Index		Screening, Week 4, Week 12, Week 24	No
Primary	Tear Breakup Time		Screening, Week 4, Week 12, Week 24	No
Primary	Corneal Staining with Fluorescein		Screening, Week 4, Week 12, Week 24	No
Primary	Impression Cytology		Screening, Week 12, Week 24	No
Primary	Conjunctival staining with lissamine		Screening, Week 4, Week 12, Week 24	No
Secondary	Corneal Topography		Screening, Week 4, Week 12, Week 24	No
Secondary	Meibomian Gland Dysfunction		Screening, Week 4, Week 12, Week 24	No
Secondary	Facial Expression Subjective Scale		Screening, Week 4, Week 12, Week 24	No
Secondary	Frequency of Artificial Tear Usage		Screening, Week 4, Week 12, Week 24	No
Secondary	HLA-DR Staining of Impression Cytology		Screening, Week 12, Week 24	No

External Links

•   Hydroeye Nutritional Supplement