Myopia
Conditions
Brief summary
The purpose of this study was to evaluate the relative benefits of daily disposable contact lenses versus spectacles in young adults.
Interventions
DEVICEnelfilcon A contact lens
Commercially marketed, single vision, soft contact lens for daily disposable wear
OTHERSpectacles
Spectacles per current prescription
Sponsors
University of Manchester
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 19 Years
Healthy volunteers
No
Inclusion criteria
* Understands rights as a research subject and willing and able to sign a Statement of Informed Consent, or if under 18, parent or guardian understands rights and is willing and able to sign a Statement of Informed Consent. * Willing and able to follow the protocol. * Currently wearing spectacles full-time (at least five days per week, eight hours per day). * Has never worn contact lenses (more than one day) before. * Agrees to not participate in other clinical research for the duration of this study. * Can attain at least 6/9 in each eye with the study optical correction. * Can be fitted with study lenses in the available power range (contact lens group) or can select a satisfactory spectacle lens frame and lenses (spectacle group). * Willing and able to wear the study lenses or spectacles for a minimum of five days per week, eight hours per day. * Owns or has regular access to a mobile phone and is familiar with SMS text messaging. * Has an up-to-date and functional pair of spectacles at time of enrollment. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Has an ocular or systemic disorder that would normally contraindicate contact lens wear. * Is using any topical medication such as eye drops or ointment. * Has had corneal refractive surgery. * Has had cataract surgery. * Has diabetes. * Has taken part in other clinical research within two weeks of starting the study. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Happiness With Correction Type | Month 6 | Participant responded to an SMS message: Please rate your happiness (H) and vision (V) with your \[contact lenses/spectacles\]: 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good. eg H2V4. Please send N if in you are not wearing \[contact lenses/spectacles\]. |
| Subjective Vision With Correction Type | Month 6 | Participant responded to an SMS message: Please rate your happiness (H) and vision (V) with your \[contact lenses/spectacles\]: 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good. eg H2V4. Please send N if in you are not wearing \[contact lenses/spectacles\]. |
Countries
United Kingdom
Participant flow
Recruitment details
Participants were enrolled from one study center in the United Kingdom.
Pre-assignment details
Of the 113 participants enrolled, 3 were exited as screen failures prior to randomization. This reporting group includes all enrolled and randomized participants (110).
Participants by arm
| Arm | Count |
|---|---|
| Nelfilcon A Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months | 57 |
| Spectacles Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months | 53 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Failed teach session | 2 | 0 |
| Overall Study | Failed to attend scheduled visit | 2 | 3 |
| Overall Study | Not comfortable in lenses | 5 | 0 |
Baseline characteristics
| Characteristic | Nelfilcon A | Spectacles | Total |
|---|---|---|---|
| Age Continuous | 16.2 years STANDARD_DEVIATION 1.8 | 16.3 years STANDARD_DEVIATION 2 | 16.2 years STANDARD_DEVIATION 1.9 |
| Region of Enrollment United Kingdom | 57 participants | 53 participants | 110 participants |
| Sex: Female, Male Female | 32 Participants | 31 Participants | 63 Participants |
| Sex: Female, Male Male | 25 Participants | 22 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 57 | 0 / 53 |
| serious Total, serious adverse events | 0 / 57 | 0 / 53 |
Outcome results
Primary
Subjective Happiness With Correction Type
Participant responded to an SMS message: Please rate your happiness (H) and vision (V) with your \[contact lenses/spectacles\]: 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good. eg H2V4. Please send N if in you are not wearing \[contact lenses/spectacles\].
Time frame: Month 6
Population: This reporting group includes all participants who sent in an SMS response.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nelfilcon A | Subjective Happiness With Correction Type | 4.92 Units on a Scale | Standard Deviation 0.3 |
| Spectacles | Subjective Happiness With Correction Type | 4.50 Units on a Scale | Standard Deviation 0.9 |
Primary
Subjective Vision With Correction Type
Participant responded to an SMS message: Please rate your happiness (H) and vision (V) with your \[contact lenses/spectacles\]: 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good. eg H2V4. Please send N if in you are not wearing \[contact lenses/spectacles\].
Time frame: Month 6
Population: This reporting group includes all participants who sent in an SMS response.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nelfilcon A | Subjective Vision With Correction Type | 4.5 Units on a scale | Standard Deviation 0.7 |
| Spectacles | Subjective Vision With Correction Type | 4.5 Units on a scale | Standard Deviation 0.8 |