Dry Eye Syndrome
Conditions
Keywords
tear osmolarity, keratitis sicca, ocular surface disease, TheraTears
Brief summary
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.
Detailed description
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.
Interventions
OTHERTheraTears lubricating drops
A over-the-counter lubricating eye drop to be used 1 drop in both eyes 4 times a day (QID) for 8 weeks
Sponsors
Advanced Vision Research
Jenkins Eye Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Is at least 21 years of age and has full legal capacity to volunteer; 2. Has read and signed the information consent letter; 3. Is willing and able to follow instructions and maintain the appointment schedule; 4. Is diagnosed with dry eye syndrome (in at least one eye), indicated by current ocular examination, prior history (self-reported history of dry eye is acceptable) and current use of treatments for dry eye; 5. Has a minimum osmolarity reading of 316 mosm/kg at the baseline visit in at least one eye.
Exclusion criteria
1. Has taken part in another research study within the last 30 days; 2. Planned contact lens wear during the course of the study; 3. Staff at the investigational site or family member of site staff or family member of currently enrolled participant; 4. Any subject that violates the washout period by using eye drops during the 72hrs washout period; 5. Has any known ocular disease including active ocular infection, inflammation or allergy, especially Salzmann's nodular degeneration, symptomatic conjunctivochalasis, and fixation disparity syndrome; 6. Used Restasis (or similar topical medication) within the last 6 months; 7. Has a systemic condition that in the opinion of the investigator may affect the dry eye status of the subject, especially those newly diagnosed, newly prescribed and/or unstable; 8. Is pregnant, lactating or planning a pregnancy at the time of enrolment (verbal confirmation necessary); 9. Use of medications such as: Systemic Antihistamine (e.g., Allegra®, Benadryl®, Claritin®, Dimetapp®, Unisom®, Zyrtec®, etc.), Isotretinoin (e.g., Accutane®, Roaccutane®, Amnesteem®, Claravis®, Isotroin®, Sotret®) or similar medications; 10. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study; 11. Has undergone ocular surgery(LASIK, Cataract, etc)within the last year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in tear osmolarity | Baseline and 8 weeks | — |
| Change in the Ocular Surface Disease Index (OSDI) score | Baseline and 8 weeks | The OSDI is a questionnaire that the subject completes to gauge their dry eye symptoms. |
Secondary
| Measure | 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 | baseline and 8 weeks |
| Change in corneal and conjunctival staining | baseline and 8 weeks |
Countries
United States
Outcome results
None listed