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Completed

NCT Number: NCT02100787

Changes in Tear Osmolarity Over Time With Sustained Use of TheraTears

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jenkins Eye Care

Honolulu, Hawaii, 96814, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TheraTears lubricating drops

Other

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

Primary outcomes

  1. Change in tear osmolarity

    Time frame: Baseline and 8 weeks

  2. Change in the Ocular Surface Disease Index (OSDI) score

    Time frame: Baseline and 8 weeks

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

Secondary outcomes

  1. Change in visual acuity

    Time frame: Baseline and 8 weeks

  2. Change in Tear Break Up Time

    Time frame: baseline and 8 weeks

  3. Change in Phenol Red Thread test

    Time frame: baseline and 8 weeks

  4. Change in corneal and conjunctival staining

    Time frame: baseline and 8 weeks

Sponsors and collaborators

Lead sponsor

Jenkins Eye Care

Other

Collaborators

  • Advanced Vision Research

Registry information

Official study title

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

Acronym: BENTLEY

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 1, 2014
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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