Myopia
Conditions
Brief summary
The purpose of this study was to assess whether young adults could adapt to and achieve satisfaction with a daily disposable contact lens.
Detailed description
This was a prospective, single group, dispensing clinical trial to determine subjective and objective visual performance measures, patient satisfaction and adaptability to a commercially available daily disposable contact lens in myopic young adults over 3 months of daily lens wear.
Interventions
Daily disposable contact lens for 3 months
Sponsors
Centre for Ocular Research & Education, Canada
CooperVision, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* Is between 17 and 25 years of age (inclusive) and has full legal capacity to volunteer; * Has read and signed an information consent letter; * Is willing and able to follow instructions and maintain the appointment schedule; * Has a vertex corrected spherical equivalent distance refraction that ranges between - 0.75D to -6.00D in each eye; * Has astigmatism ≤ -0.75 DC in either eye, by refraction; * Be correctable to better than 0.20 logMAR in each eye by refraction; * Has habitually worn spherical soft contact lenses to correct for distance vision (i.e. no multifocal or monovision) for the past 3 months; * Is willing to wear contact lenses for at least 10 hours a day, 6 days a week while in the study; * Demonstrates an acceptable fit with the study lenses; * Has ocular health findings considered to be normal and which would not prevent the participant from safely wearing contact lenses.
Exclusion criteria
* Is participating in any concurrent clinical or research study; * Has a history of amblyopia; * Has TNO Stereoacuity worse than 120 arc / or Titmus worse than 100 arc; * Has any known active ocular disease and/or infection; * Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; * Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; * Has known sensitivity to the diagnostic pharmaceutical (sodium fluorescein) to be used in the study; * Is pregnant, lactating or planning a pregnancy at the time of enrolment (verbal confirmation at the screening visit); * Is pseudophakic; * Has undergone refractive error surgery; * Has one of following experiences with MiSight lenses: * Is currently wearing MiSight lenses or * Has worn MiSight lenses for more than one week at any given time or * Has worn MiSight lenses for any more than 30 minutes in the past 30 days; * Has had orthokeratology treatment within the last 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Quality of Vision (QoV) | 3 months | The Subjective Quality of Vision (QoV) questionnaire consisted of 30 items assessing 10 visual symptoms. Each symptom was evaluated using three sub-questions: frequency, severity, and bothersomeness. All subquestions were rated on a 4-point scale from 0 to 3, where higher values represent a higher severity, frequency, or bothersomeness. For analysis, each dimension-frequency, severity, and bothersomeness-was treated independently. Scores for each were calculated by summing the responses across all 10 symptoms, resulting in separate total scores for each dimension. Each total score ranged from 0 to 30. Thus, the Overall Frequency of Symptoms, Overall Severity, and Overall Bothersomeness scores each represent the sum of the respective ratings across all visual symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Contact Lens Impact on Quality of Life (CLIQ) | 3 months | Participant quality of life was measured after 3 months of lens wear using a CLIQ 28-item questionnaire. Each question was scored on a 1-5 integer scale, where 1=never and 5=always. As written, scores were not consistently associated with a better or worse outcome. An algorithm was later applied for consistency (i.e., for categories \[1,2,3,4,5\], for the first 20 questions \[5,4,3,3,3\] are assigned and for 21-28 \[2,2,3,4,5\]). After the conversion, the average of all scores was used to measure the CLIQ. The CLIQ score ranged from a minimum of 2.71 to a maximum of 5, with 5 representing the best score. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Daily Disposable Contact Lens Participants wore a daily disposable contact lens for 3 months. | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Daily Disposable Contact Lens | — |
|---|---|---|
| Age, Continuous | 22.5 years STANDARD_DEVIATION 1.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 25 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 4 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
Primary
Subjective Quality of Vision (QoV)
The Subjective Quality of Vision (QoV) questionnaire consisted of 30 items assessing 10 visual symptoms. Each symptom was evaluated using three sub-questions: frequency, severity, and bothersomeness. All subquestions were rated on a 4-point scale from 0 to 3, where higher values represent a higher severity, frequency, or bothersomeness. For analysis, each dimension-frequency, severity, and bothersomeness-was treated independently. Scores for each were calculated by summing the responses across all 10 symptoms, resulting in separate total scores for each dimension. Each total score ranged from 0 to 30. Thus, the Overall Frequency of Symptoms, Overall Severity, and Overall Bothersomeness scores each represent the sum of the respective ratings across all visual symptoms.
Time frame: 3 months
Population: The 2 discontinuations occurred after lens dispensing but prior to the first follow up visit. These participants were excluded from the data analysis population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daily Disposable Contact Lens | Subjective Quality of Vision (QoV) | Overall Frequency | 6.1 score on a scale | Standard Deviation 3.6 |
| Daily Disposable Contact Lens | Subjective Quality of Vision (QoV) | Overall Severity | 5.3 score on a scale | Standard Deviation 3.5 |
| Daily Disposable Contact Lens | Subjective Quality of Vision (QoV) | Overall Bothersomeness | 4.7 score on a scale | Standard Deviation 4.1 |
Secondary
Contact Lens Impact on Quality of Life (CLIQ)
Participant quality of life was measured after 3 months of lens wear using a CLIQ 28-item questionnaire. Each question was scored on a 1-5 integer scale, where 1=never and 5=always. As written, scores were not consistently associated with a better or worse outcome. An algorithm was later applied for consistency (i.e., for categories \[1,2,3,4,5\], for the first 20 questions \[5,4,3,3,3\] are assigned and for 21-28 \[2,2,3,4,5\]). After the conversion, the average of all scores was used to measure the CLIQ. The CLIQ score ranged from a minimum of 2.71 to a maximum of 5, with 5 representing the best score.
Time frame: 3 months
Population: The 2 discontinuations occurred after lens dispensing but prior to the first follow up visit. These participants were excluded from the data analysis population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Daily Disposable Contact Lens | Contact Lens Impact on Quality of Life (CLIQ) | 4.1 score on a scale | Standard Deviation 0.5 |