NCT02100787

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2014

Completed
9 days until next milestone

Study Start

First participant enrolled

April 10, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2016

Completed
Last Updated

March 3, 2017

Status Verified

February 1, 2017

Enrollment Period

2 years

First QC Date

March 27, 2014

Last Update Submit

February 28, 2017

Conditions

Dry Eye Syndrome

Keywords

tear osmolaritykeratitis siccaocular surface diseaseTheraTears

Outcome Measures

Primary Outcomes (2)

  • Change in tear osmolarity

    Baseline and 8 weeks

  • 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 Outcomes (4)

  • 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

Study Arms (1)

TheraTears lubricating drops

EXPERIMENTAL

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

Other: TheraTears lubricating drops

Interventions

TheraTears lubricating dropsOTHER

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

TheraTears lubricating drops

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jenkins Eye Care

Honolulu, Hawaii, 96814, United States

Location

Related Publications (2)

  • 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.

    PMID: 23402632RESULT

  • 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.

    PMID: 12786773RESULT

MeSH Terms

Conditions

Dry Eye SyndromesKeratitis sicca

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Loretta Ng, OD

    Jenkins Eye Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2014

First Posted

April 1, 2014

Study Start

April 10, 2014

Primary Completion

April 12, 2016

Study Completion

June 30, 2016

Last Updated

March 3, 2017

Record last verified: 2017-02

Locations

US(1)