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| Name | Class |
|---|---|
| ScienceBased Health | INDUSTRY |
| Baylor College of Medicine | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroeye | Dietary Supplement | 2 Capsules BID |
| |
| Inactive Capsule |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | United States | ||
| Virginia Eye Consultants |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23884332 | Derived | 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. |
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| ID | Term |
|---|---|
| D007638 | Keratoconjunctivitis Sicca |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007637 | Keratoconjunctivitis |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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| Other |
2 Capsules BID |
|
| 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 |
| Norfolk |
| Virginia |
| 23502 |
| United States |
| D007634 |
| Keratitis |
| D003316 | Corneal Diseases |
| D007766 | Lacrimal Apparatus Diseases |