Trial Outcomes & Findings for The Effect of Masking on Subjective Results During Daily Disposable Contact Lens Studies (NCT NCT01155726)
NCT ID: NCT01155726
Last Updated: 2012-07-10
Results Overview
Participants were asked, "How would you rate your comfort with your study lenses?" and indicated their response by marking a continuum line ranging from 0=very poor comfort to 100=excellent comfort. Subjective comfort was collected at three time points (insertion, 4 hours, 8 hours) for 3 days, and the comfort ratings were averaged together.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
134 participants
Primary outcome timeframe
Insertion, 4 hours, 8 hours each: Day 1, Day 2, and Day 3
Results posted on
2012-07-10
Participant Flow
134 participants were recruited and enrolled at 1 study center located in Canada. A 24-hour washout period of no lens wear preceded the 30-day adaptation phase.
18 participants were enrolled but not dispensed--i.e., discontinued prior to the 30-day adaptation phase. 116 participants started the adaptation phase, and baseline characteristics are presented for this group. 2 discontinued during the adaptation phase and 15 discontinued between adaptation and Period 1 dispense. 99 were dispensed into Period 1.
Participant milestones
| Measure |
Nelfilcon A, Masked, Unmasked
Nelfilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, unmasked) in Period 2.
|
Nelfilcon A, Masked, Partially Masked
Nelfilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, partially masked) in Period 2.
|
Etafilcon A, Masked, Unmasked
Etafilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, unmasked) in Period 2.
|
Etafilcon A, Masked, Partially Masked
Etafilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, partially masked) in Period 2.
|
|---|---|---|---|---|
|
Period 1, 3 Days (Masked)
STARTED
|
24
|
20
|
30
|
25
|
|
Period 1, 3 Days (Masked)
COMPLETED
|
23
|
20
|
28
|
25
|
|
Period 1, 3 Days (Masked)
NOT COMPLETED
|
1
|
0
|
2
|
0
|
|
Period 2, 3 Days (Unmask) or (Partial)
STARTED
|
23
|
20
|
28
|
25
|
|
Period 2, 3 Days (Unmask) or (Partial)
COMPLETED
|
23
|
20
|
28
|
25
|
|
Period 2, 3 Days (Unmask) or (Partial)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Nelfilcon A, Masked, Unmasked
Nelfilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, unmasked) in Period 2.
|
Nelfilcon A, Masked, Partially Masked
Nelfilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, partially masked) in Period 2.
|
Etafilcon A, Masked, Unmasked
Etafilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, unmasked) in Period 2.
|
Etafilcon A, Masked, Partially Masked
Etafilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, partially masked) in Period 2.
|
|---|---|---|---|---|
|
Period 1, 3 Days (Masked)
Inconvenience
|
1
|
0
|
2
|
0
|
Baseline Characteristics
The Effect of Masking on Subjective Results During Daily Disposable Contact Lens Studies
Baseline characteristics by cohort
| Measure |
Overall
n=116 Participants
This reporting group includes all enrolled and dispensed participants.
|
|---|---|
|
Age Continuous
|
25 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Insertion, 4 hours, 8 hours each: Day 1, Day 2, and Day 3Population: Per protocol
Participants were asked, "How would you rate your comfort with your study lenses?" and indicated their response by marking a continuum line ranging from 0=very poor comfort to 100=excellent comfort. Subjective comfort was collected at three time points (insertion, 4 hours, 8 hours) for 3 days, and the comfort ratings were averaged together.
Outcome measures
| Measure |
Nelfilcon A, Pd 1 Masked (1DAVM), Pd 2 Unmasked
n=23 Participants
Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
|
Nelfilcon A, Pd 1 Masked (DACP), Pd 2 Unmasked
n=23 Participants
Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
|
Etafilcon A, Pd 1 Masked (1DAVM), Pd 2 Unmasked
n=28 Participants
Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
|
Etafilcon A, Pd 1 Masked (DACP), Pd 2 Unmasked
n=28 Participants
Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
|
Nelfilcon A, Pd 1 Masked, Pd 2 Unmasked (1DAVM)
n=23 Participants
Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
|
Nelfilcon A, Pd 1 Masked, Pd 2 Unmasked (DACP)
n=23 Participants
Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
|
Etafilcon A, Pd 1 Masked, Pd 2 Unmasked (1DAVM)
n=28 Participants
Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
|
Etafilcon A, Pd 1 Masked, Pd 2 Unmasked (DACP)
n=28 Participants
Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
|
Nelfilcon A, Pd 1 Masked (1DAVM), Pd 2 Partial
n=20 Participants
Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
|
Nelfilcon A, Pd 1 Masked (DACP), Pd 2 Partial
n=20 Participants
Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
|
Etafilcon A, Pd 1 Masked (1DAVM), Pd 2 Partial
n=25 Participants
Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
|
Etafilcon A, Pd 1 Masked (DACP), Pd 2 Partial
n=25 Participants
Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
|
Nelfilcon A, Pd 1 Masked, Pd 2 Partial (1DAVM)
n=20 Participants
Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
|
Nelfilcon A, Pd 1 Masked, Pd 2 Partial (DACP)
n=20 Participants
Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
|
Etafilcon A, Pd 1 Masked, Pd 2 Partial (1DAVM)
n=25 Participants
Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
|
Etafilcon A, Pd 1 Masked, Pd 2 Partial (DACP)
n=25 Participants
Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Average Subjective Comfort
|
94.1 Units on a scale
Standard Deviation 5.9
|
92.8 Units on a scale
Standard Deviation 6.5
|
94.1 Units on a scale
Standard Deviation 5.6
|
91.8 Units on a scale
Standard Deviation 6.4
|
93.7 Units on a scale
Standard Deviation 6.0
|
93.3 Units on a scale
Standard Deviation 5.7
|
95.2 Units on a scale
Standard Deviation 5.8
|
93.7 Units on a scale
Standard Deviation 6.6
|
93.4 Units on a scale
Standard Deviation 6.9
|
93.4 Units on a scale
Standard Deviation 7.1
|
93.6 Units on a scale
Standard Deviation 5.1
|
92.2 Units on a scale
Standard Deviation 5.6
|
92.3 Units on a scale
Standard Deviation 7.0
|
93.1 Units on a scale
Standard Deviation 7.0
|
93.5 Units on a scale
Standard Deviation 6.7
|
92.6 Units on a scale
Standard Deviation 5.8
|
Adverse Events
Nelfilcon A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Etafilcon A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1DAVM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DACP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director of Clinical Trials
Alcon Research
Phone: 1-800-241-7629
Results disclosure agreements
- Principal investigator is a sponsor employee For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.
- Publication restrictions are in place
Restriction type: OTHER