Contact Lens Complication, Dry Eye
Conditions
Keywords
Contact Lens, Dailies Total1, Dry Eye, Comfort
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.
Interventions
DEVICEDT1 Sphere Contact Lenses
Devices: Dailies Total 1 Sphere Contact Lenses
Sponsors
Alcon Research
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) Contact Lenses Comfort Scores | 1 month | The median visual analog scale (VAS) scores at the 1-month visit (-50 to +50 scale with scores greater than 0 being comfortable). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Likert Questionnaire | One Month | Number of participants who were likely to refer the study contact lens to a friend. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dailies Total1 All participants will be asked to wear Dailies Total1 for the duration of this study.
DT1 Sphere Contact Lenses: Devices: Dailies Total 1 Sphere Contact Lenses | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Dailies Total1 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants |
| Age, Continuous | 24 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 51 Participants |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Visual Analog Scale (VAS) Contact Lenses Comfort Scores
The median visual analog scale (VAS) scores at the 1-month visit (-50 to +50 scale with scores greater than 0 being comfortable).
Time frame: 1 month
Population: Subjects were recruited via clinic records, email and fliers, and they were pre-screened with an Institutional Review Board (IRB)- approved qualification questionnaire over the telephone. Adult, 18- to 40-year-old (inclusive), past CL wearers who had a Logarithm of the Minimum Angle of Resolution (logMAR) best-corrected visual acuity of 0.00 or better were recruited. Subjects were required to have worn CLs for at least 1year in the past.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dailies Total1 | Visual Analog Scale (VAS) Contact Lenses Comfort Scores | 44 Score on a scale |
Comparison: This study used a ±50 VAS scale, with values in the positive and negative range indicating that the contact lenses were comfortable or uncomfortable, respectively. A score of zero on this scale indicated neutral CL comfort.p-value: <0.001Shapiro-Wilks
Secondary
Likert Questionnaire
Number of participants who were likely to refer the study contact lens to a friend.
Time frame: One Month
Population: All subjects who completed the 1 month visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dailies Total1 | Likert Questionnaire | 59 Participants |