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

Primary Purpose

Dry Eye Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

TheraTears lubricating drops

About this trial

This is an interventional treatment trial for Dry Eye Syndrome focused on measuring tear osmolarity, keratitis sicca, ocular surface disease, TheraTears

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Jenkins Eye Care

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TheraTears lubricating drops

Arm Description

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

Outcomes

Primary Outcome Measures

Change in tear osmolarity

Change in the Ocular Surface Disease Index (OSDI) score

The OSDI is a questionnaire that the subject completes to gauge their dry eye symptoms.

Secondary Outcome Measures

Change in visual acuity

Change in Tear Break Up Time

Change in Phenol Red Thread test

Change in corneal and conjunctival staining

Full Information

NCT ID

NCT02100787

First Posted

March 27, 2014

Last Updated

February 28, 2017

Sponsor

Jenkins Eye Care

Collaborators

Advanced Vision Research

1. Study Identification

Unique Protocol Identification Number

NCT02100787

Brief Title

Changes in Tear Osmolarity Over Time With Sustained Use of TheraTears

Acronym

BENTLEY

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

April 10, 2014 (Actual)

Primary Completion Date

April 12, 2016 (Actual)

Study Completion Date

June 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jenkins Eye Care

Collaborators

Advanced Vision Research

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Syndrome

Keywords

tear osmolarity, keratitis sicca, ocular surface disease, TheraTears

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TheraTears lubricating drops

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

TheraTears lubricating drops

Intervention Description

A over-the-counter lubricating eye drop to be used 1 drop in both eyes 4 times a day (QID) for 8 weeks

Primary Outcome Measure Information:

Title

Change in tear osmolarity

Time Frame

Baseline and 8 weeks

Title

Change in the Ocular Surface Disease Index (OSDI) score

Description

The OSDI is a questionnaire that the subject completes to gauge their dry eye symptoms.

Time Frame

Baseline and 8 weeks

Secondary Outcome Measure Information:

Title

Change in visual acuity

Time Frame

Baseline and 8 weeks

Title

Change in Tear Break Up Time

Time Frame

baseline and 8 weeks

Title

Change in Phenol Red Thread test

Time Frame

baseline and 8 weeks

Title

Change in corneal and conjunctival staining

Time Frame

baseline and 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Loretta Ng, OD

Organizational Affiliation

Jenkins Eye Care

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jenkins Eye Care

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96814

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23402632

Citation

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.

Results Reference

result

PubMed Identifier

12786773

Citation

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.

Results Reference

result

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Changes in Tear Osmolarity Over Time With Sustained Use of TheraTears

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