BENTLEY: Changes in Tear Osmolarity Over Time With Sustained Use of TheraTears

Sponsor

Jenkins Eye Care (Other)

Overall Status

Completed

CT.gov ID

NCT02100787

Collaborator

Advanced Vision Research (Industry)

Enrollment

Location

Arm

26.7

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome	Other: TheraTears lubricating drops	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluation of Tear Osmolarity Over Time With Sustained Use of TheraTears Lubricating Drops

Actual Study Start Date :

Apr 10, 2014

Actual Primary Completion Date :

Apr 12, 2016

Actual Study Completion Date :

Jun 30, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TheraTears lubricating drops TheraTears lubricating eye drops to be used 1 drop in both eyes four times a day (QID)	Other: TheraTears 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

Arm

Intervention/Treatment

Experimental: TheraTears lubricating drops

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

Other: TheraTears 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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Is at least 21 years of age and has full legal capacity to volunteer;
Has read and signed the information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
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;
Has a minimum osmolarity reading of 316 mosm/kg at the baseline visit in at least one eye.

Exclusion Criteria:

Has taken part in another research study within the last 30 days;
Planned contact lens wear during the course of the study;
Staff at the investigational site or family member of site staff or family member of currently enrolled participant;
Any subject that violates the washout period by using eye drops during the 72hrs washout period;
Has any known ocular disease including active ocular infection, inflammation or allergy, especially Salzmann's nodular degeneration, symptomatic conjunctivochalasis, and fixation disparity syndrome;
Used Restasis (or similar topical medication) within the last 6 months;
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;
Is pregnant, lactating or planning a pregnancy at the time of enrolment (verbal confirmation necessary);
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;
Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
Has undergone ocular surgery(LASIK, Cataract, etc)within the last year.