Trial Outcomes & Findings for A Lifestyle Investigation With Spectacles and Daily Disposable Contact Lenses in Young Patients (NCT NCT01445652)
NCT ID: NCT01445652
Last Updated: 2013-09-19
Results Overview
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 \[contact lenses/spectacles\]."
COMPLETED
NA
113 participants
Month 6
2013-09-19
Participant Flow
Participants were enrolled from one study center in the United Kingdom.
Of the 113 participants enrolled, 3 were exited as screen failures prior to randomization. This reporting group includes all enrolled and randomized participants (110).
Participant milestones
| Measure |
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
|
Spectacles
Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
53
|
|
Overall Study
COMPLETED
|
47
|
50
|
|
Overall Study
NOT COMPLETED
|
10
|
3
|
Reasons for withdrawal
| Measure |
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
|
Spectacles
Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
|
|---|---|---|
|
Overall Study
Not comfortable in lenses
|
5
|
0
|
|
Overall Study
Failed to attend scheduled visit
|
2
|
3
|
|
Overall Study
Failed teach session
|
2
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
A Lifestyle Investigation With Spectacles and Daily Disposable Contact Lenses in Young Patients
Baseline characteristics by cohort
| Measure |
Nelfilcon A
n=57 Participants
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
|
Spectacles
n=53 Participants
Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
16.2 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
16.3 years
STANDARD_DEVIATION 2.0 • n=7 Participants
|
16.2 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
57 participants
n=5 Participants
|
53 participants
n=7 Participants
|
110 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: This reporting group includes all participants who sent in an SMS response.
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 \[contact lenses/spectacles\]."
Outcome measures
| Measure |
Nelfilcon A
n=14 Participants
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
|
Spectacles
n=21 Participants
Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
|
|---|---|---|
|
Subjective Happiness With Correction Type
|
4.92 Units on a Scale
Standard Deviation 0.3
|
4.50 Units on a Scale
Standard Deviation 0.9
|
PRIMARY outcome
Timeframe: Month 6Population: This reporting group includes all participants who sent in an SMS response.
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 \[contact lenses/spectacles\]."
Outcome measures
| Measure |
Nelfilcon A
n=14 Participants
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
|
Spectacles
n=21 Participants
Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
|
|---|---|---|
|
Subjective Vision With Correction Type
|
4.5 Units on a scale
Standard Deviation 0.7
|
4.5 Units on a scale
Standard Deviation 0.8
|
Adverse Events
Nelfilcon A
Spectacles
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nelfilcon A
n=57 participants at risk
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
|
Spectacles
n=53 participants at risk
Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
|
|---|---|---|
|
Eye disorders
Corneal inflammatory event
|
7.0%
4/57 • Adverse events were collected for the duration of the study (9 months). An adverse event was defined as any unfavourable or unintended sign or symptom associated with the use of a contact lens, but not necessarily caused by the contact lens.
This reporting group includes all enrolled and randomized participants.
|
0.00%
0/53 • Adverse events were collected for the duration of the study (9 months). An adverse event was defined as any unfavourable or unintended sign or symptom associated with the use of a contact lens, but not necessarily caused by the contact lens.
This reporting group includes all enrolled and randomized participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER