Dailies Total 1 Sphere Contact Lenses

Study Overview
=================
Brief Summary
-----------------
CL discomfort is a complex phenomenon that has been defined by the Tear Film and Ocular Surface Society in their seminal report on contact lens (CL) discomfort as a condition that results in episodic or persistent adverse ocular sensation related to lens wear, either with or without visual disturbance resulting from reduced compatibility between the CL and the environment, which can lead to decreased wearing time and discontinuation of CL wear. A recent review by Pucker and Tichenor found that CL discomfort was the top reason for established CL wears to cease wearing CLs. This same review alarmingly found that the frequency of CL dropout was about 20% across the many studies aimed at evaluating this condition, which is surprising given the introduction of better soft CL materials and daily disposable CLs over the past 20 plus years. Dailies Total1 (DT1), which is a relatively new daily disposable CL, is a commonly used trouble shooting CL for patients who have failed with other CLs because DT1 utilizes advanced material technology that is specifically aimed at improving CL comfort. While DT1 is commonly used in these struggling patients, the literature currently lacks a targeted study aimed at understanding the frequency of successfully refitting CL dropouts into this advanced CL. Thus, the purpose of this study is to determine the frequency that past CL wearers who failed because of dryness or CL discomfort who can comfortable wear DT1.

Official Title
-----------------
How Does DT1 Sphere Perform in Those Who Previously Dropped Out of Contact Lenses Due to Comfort or Dryness?

Conditions
-----------------
Dry Eye, Contact Lens Complication

Intervention / Treatment
-----------------
* Device: DT1 Sphere Contact Lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults 18-40 Past contact lens wearers who have best corrected 20/20 visual acuity or better Participants will have had to have worn contact lenses for at least 1 year in the past Dropped out of contact lenses in the past 2 years do to discomfort or dryness Scores of 3 or less on the SPEED questionnaire Be able to be refit into Dailies Total1 Sphere contact lenses Provide a glasses prescription that is less than 3-years-old Exclusion Criteria: Past rigid contact lens wearers A past history of being diagnosed with dry eye or ocular allergies Known systemic health conditions that are known to alter tear film physiology History of viral eye disease History of ocular surgery History of severe ocular trauma History of corneal dystrophies or degeneration Having active ocular infection or inflammation Currently using isotretinoin-derivatives or ocular medication Pregnant or breast feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: All participants will be assigned to wear Dailies Total 1 Sphere contact lenses. They will report to 3 in person visits over the course of one month.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dailies Total1<br>All participants will be asked to wear Dailies Total1 for the duration of this study. | Device: DT1 Sphere Contact Lenses<br>* Devices: Dailies Total 1 Sphere Contact Lenses<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) Contact Lenses Comfort Scores | The frequency of participants who have comfortable (positive) visual analog scale (VAS) scores at both the 1-month (-50 to +50 scale with scores greater than 0 being comfortable). | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contact Lens, Dailies Total1, Dry Eye, Comfort