Overview

Evaluation of Tear Osmolarity Over Time With Sustained Use of Thera Tears Lubricating Drops

Status:
Completed
Trial end date:
2016-03-01
Target enrollment:
0
Participant gender:
All
Summary
The objective of the study is to demonstrate a change in osmolarity over time when moderate to severe dry eye subjects are treated with TheraTears lubricating drops.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Koffler Vision Group
Collaborator:
Akorn, Inc.
Treatments:
Carboxymethylcellulose Sodium
Lubricant Eye Drops
Ophthalmic Solutions
Tetrahydrozoline
Criteria
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 or a osmolarity reading of at least 308 (in worse eye) and at least an 8 point
difference between the two eyes.

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. Restasis use can be included if they have been on it for at least 3 months and are
stable.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 systemic anti-histamines, as long as they have been on them continuously for at
least 1 month. 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;

- For purposes of this study, ocular conditions that are typically associated with
dry eye status, such as meibomian gland dysfunction, mild (i.e. not considered
clinically relevant) blepharitis, corneal and conjunctival staining are not
considered an exclusion.