NCT00883649

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 20, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

February 20, 2012

Status Verified

February 1, 2012

Enrollment Period

3.2 years

First QC Date

April 17, 2009

Last Update Submit

February 16, 2012

Conditions

Keratoconjunctivitis Sicca

Keywords

Keratoconjunctivitis SiccaDry EyesPost-menopausal

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (5)

  • 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

Study Arms (2)

1

PLACEBO COMPARATOR
Other: Inactive Capsule

2

ACTIVE COMPARATOR
Dietary Supplement: Hydroeye

Interventions

HydroeyeDIETARY_SUPPLEMENT

2 Capsules BID

2
Inactive CapsuleOTHER

2 Capsules BID

1

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Virginia Eye Consultants

Norfolk, Virginia, 23502, United States

Location

Related Publications (1)

  • 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.

    PMID: 23884332DERIVED

MeSH Terms

Conditions

Keratoconjunctivitis SiccaDry Eye Syndromes

Condition Hierarchy (Ancestors)

KeratoconjunctivitisConjunctivitisConjunctival DiseasesEye DiseasesKeratitisCorneal DiseasesLacrimal Apparatus Diseases

Study Officials

  • John D Sheppard, M.D.

    Virginia Eye Consultants

    PRINCIPAL INVESTIGATOR

  • Stephen C Pflugfelder, M.D.

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

  • Joe Wakil, M.D.

    ScienceBased Health

    STUDY CHAIR

  • Penelope Edwards, MPH, CNS

    ScienceBased Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2009

First Posted

April 20, 2009

Study Start

September 1, 2008

Primary Completion

December 1, 2011

Last Updated

February 20, 2012

Record last verified: 2012-02

Locations

US(2)