Changes in Tear Osmolarity Over Time With Sustained Use of TheraTears

Not Applicable

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Other: TheraTears lubricating drops

• Registration Number: NCT02100787
• Lead Sponsor: Jenkins Eye Care

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.

Study Timeline

• Study First Submitted: 2014-03-27
• Study First Submitted QC: 2014-03-27
• Study First Posted: 2014-04-01
• Study Start: 2014-04-10
• Primary Completion: 2016-04-12
• Study Completion: 2016-06-30
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TheraTears lubricating drops	TheraTears lubricating drops	TheraTears lubricating eye drops to be used 1 drop in both eyes four times a day (QID)

Primary Outcome Measures

Name	Time	Method
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.
Change in tear osmolarity	Baseline and 8 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Jenkins Eye Care; 🇺🇸 Honolulu, Hawaii, United States