N/A
N=57
Dry Eye Symptom Relief Assessment With Use of TrueTear in a Controlled Adverse Environment
Dry Eye · Dry Eye Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT03097614 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Eye Dryness Score — 48 Score on Scale — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TrueTear (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Oculeve, Inc.
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Eye Dryness Score |
48 | 0.0001 sig |
Summary
This study characterizes acute dry eye symptom control, assessed during exposure to a Controlled Adverse Environment, following use of the TrueTear for 45 days.
Eligibility Criteria
Inclusion Criteria
- Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to the Screening Visit
- Normal lid/lash anatomy, blinking function and closure as determined by the Investigator
- Literate, able to speak English, and able to complete questionnaires independently
Exclusion Criteria
- Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the Investigator, may lead to risk of clinically significant increased bleeding
- Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
- Contact lens use within 7 days prior to the Screening Visit or anticipate the use of contact lenses at any time during the study
- Corneal transplant in either or both eyes
- Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head
- A woman who is pregnant, nursing an infant, or planning a pregnancy during the duration of the study
- Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to the Screening Visit
Data sourced from ClinicalTrials.gov (NCT03097614). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.