Trial Outcomes & Findings for Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 2 (NCT NCT01684046)
NCT ID: NCT01684046
Last Updated: 2014-04-29
Results Overview
Lens wear comfort was assessed by the participant on a 5-point Likert scale. The participant was instructed to select a single response to the statement, "When I use this solution, I can comfortably wear my lenses," with 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = strongly agree.
COMPLETED
NA
196 participants
Day 30
2014-04-29
Participant Flow
Participants were recruited from 5 study centers located in the US, 2 study centers located in the UK, and 3 study centers located in Germany.
Of the 196 enrolled, 4 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants who were exposed to a study regimen (test or control) (192).
Participant milestones
| Measure |
PureMoist - RevitaLens
Opti-Free® PureMoist® MPDS, followed by RevitaLens MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
|
RevitaLens - PureMoist
RevitaLens MPDS, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
|
|---|---|---|
|
Period 1, First 30 Days
STARTED
|
97
|
95
|
|
Period 1, First 30 Days
COMPLETED
|
97
|
93
|
|
Period 1, First 30 Days
NOT COMPLETED
|
0
|
2
|
|
Period 2, Second 30 Days
STARTED
|
97
|
93
|
|
Period 2, Second 30 Days
COMPLETED
|
97
|
93
|
|
Period 2, Second 30 Days
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
PureMoist - RevitaLens
Opti-Free® PureMoist® MPDS, followed by RevitaLens MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
|
RevitaLens - PureMoist
RevitaLens MPDS, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
|
|---|---|---|
|
Period 1, First 30 Days
Adverse Event
|
0
|
2
|
Baseline Characteristics
Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 2
Baseline characteristics by cohort
| Measure |
PureMoist / RevitaLens
n=192 Participants
Opti-Free® PureMoist® MPDS and RevitaLens MPDS used during Period 1 and Period 2 in randomized order in crossover assignment.
|
|---|---|
|
Age, Continuous
|
32.0 years
STANDARD_DEVIATION 11.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
142 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 30Population: This analysis population includes all participants who were exposed to study regimen (test and control) and completed both study periods, excluding major protocol deviations.
Lens wear comfort was assessed by the participant on a 5-point Likert scale. The participant was instructed to select a single response to the statement, "When I use this solution, I can comfortably wear my lenses," with 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = strongly agree.
Outcome measures
| Measure |
PureMoist
n=183 Participants
Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
|
RevitaLens
n=183 Participants
RevitaLens MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
|
|---|---|---|
|
Subjective Lens Wear Comfort
|
4.3 units on a scale
Standard Deviation 0.89
|
4.3 units on a scale
Standard Deviation 0.72
|
Adverse Events
PureMoist
RevitaLens
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
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