Changes in Tear Osmolarity Over Time With Sustained Use of TheraTears

Dry Eye Syndrome Clinical Trial

— BENTLEY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02100787
• Other study ID #: AVR_PM_102_13
• Status: Completed
• Phase: N/A
• First received: March 27, 2014
• Last updated: February 28, 2017
• Start date: April 10, 2014
• Est. completion date: June 30, 2016

Study information

• Verified date: February 2017
• Source: Jenkins Eye Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 30, 2016
• Est. primary completion date: April 12, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

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

Locations

Country	Name	City	State
United States	Jenkins Eye Care	Honolulu	Hawaii

Sponsors (2)

Lead Sponsor	Collaborator
Jenkins Eye Care	Advanced Vision Research

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in tear osmolarity		Baseline and 8 weeks
Primary	Change in the Ocular Surface Disease Index (OSDI) score	The OSDI is a questionnaire that the subject completes to gauge their dry eye symptoms.	Baseline and 8 weeks
Secondary	Change in visual acuity		Baseline and 8 weeks
Secondary	Change in Tear Break Up Time		baseline and 8 weeks
Secondary	Change in Phenol Red Thread test		baseline and 8 weeks
Secondary	Change in corneal and conjunctival staining		baseline and 8 weeks