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

NCT00883649 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2012-02-20

No results posted yet for this study

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.

Conditions

  • Keratoconjunctivitis Sicca

Interventions

DIETARY_SUPPLEMENT

Hydroeye

2 Capsules BID

OTHER

Inactive Capsule

2 Capsules BID

Sponsors & Collaborators

  • ScienceBased Health

    collaborator INDUSTRY
  • Baylor College of Medicine

    collaborator OTHER
  • Virginia Eye Consultants

    lead OTHER

Principal Investigators

  • John D Sheppard, M.D. · Virginia Eye Consultants

  • Stephen C Pflugfelder, M.D. · Baylor College of Medicine

  • Joe Wakil, M.D. · ScienceBased Health

  • Penelope Edwards, MPH, CNS · ScienceBased Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2011-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00883649 on ClinicalTrials.gov