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| Name | Class |
|---|---|
| Advanced Vision Research | INDUSTRY |
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The objective of the study is to see if there is a change in tear osmolarity over time when moderate to severe dry eye subjects are treated with TheraTears® lubricating drops.
The hypothesis is that the measured tear osmolarity from study participants decrease with sustained use of a over-the-counter artificial tears, TheraTears® lubricating drops, over an eight week period. Participant's dry eye symptoms would also improve with sustained use of TheraTears® lubricating drops.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TheraTears lubricating drops | Experimental | TheraTears lubricating eye drops to be used 1 drop in both eyes four times a day (QID) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TheraTears lubricating drops | Other | A over-the-counter lubricating eye drop to be used 1 drop in both eyes 4 times a day (QID) for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in tear osmolarity | Baseline and 8 weeks | |
| Change in the Ocular Surface Disease Index (OSDI) score | The OSDI is a questionnaire that the subject completes to gauge their dry eye symptoms. | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in visual acuity | Baseline and 8 weeks | |
| Change in Tear Break Up Time | baseline and 8 weeks | |
| Change in Phenol Red Thread test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Loretta Ng, OD | Jenkins Eye Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jenkins Eye Care | Honolulu | Hawaii | 96814 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23402632 | Result | Keech A, Senchyna M, Jones L. Impact of time between collection and collection method on human tear fluid osmolarity. Curr Eye Res. 2013 Apr;38(4):428-36. doi: 10.3109/02713683.2013.763987. Epub 2013 Feb 12. | |
| 12786773 | Result | Chia EM, Mitchell P, Rochtchina E, Lee AJ, Maroun R, Wang JJ. Prevalence and associations of dry eye syndrome in an older population: the Blue Mountains Eye Study. Clin Exp Ophthalmol. 2003 Jun;31(3):229-32. doi: 10.1046/j.1442-9071.2003.00634.x. |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| C531719 | Keratitis sicca |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| baseline and 8 weeks |
| Change in corneal and conjunctival staining | baseline and 8 weeks |