Changes in Tear Osmolarity Over Time With Sustained Use of TheraTears

NCT ID: NCT02100787

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-10
• Study Completion Date: 2016-06-30

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.

Conditions

Dry Eye Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TheraTears lubricating drops

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

Group Type: EXPERIMENTAL

TheraTears lubricating drops

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility 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.

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Advanced Vision Research

INDUSTRY

Sponsor Role: collaborator

Jenkins Eye Care

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Loretta Ng, OD

Role: PRINCIPAL_INVESTIGATOR

Jenkins Eye Care

Locations

Jenkins Eye Care

Honolulu, Hawaii, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 23402632 (View on PubMed)

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.

Reference Type: RESULT

PMID: 12786773 (View on PubMed)

Other Identifiers

AVR_PM_102_13

Identifier Type: -

Identifier Source: org_study_id