Trial Outcomes & Findings for Evaluation of Deposits on Contact Lenses Worn Daily Wear (NCT NCT00725153)
NCT ID: NCT00725153
Last Updated: 2012-08-23
Results Overview
Film and discrete deposits were assessed with a slit-lamp after 10 hours of lens wear. Film deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=slight, deposition occupying 1-5% of lens front surface; 2=mild, deposition occupying 6-15% of lens front surface; 3=moderate, deposition occupying 16-25% of lens front surface; 4=severe, deposition occupying \>25% of lens front surface. Discrete deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=microdeposits (less than or equal to 10 dots); 2=microdeposits (greater than 10 dots); 3=macro deposits; 4=one or more jelly bumps. Participants were classified into Front Surface Lens Deposits \<2 (less than grade 2 for both film and discrete) and into front surface lens deposits \>1 (greater than grade 1 for either film, discrete, or both).
COMPLETED
NA
55 participants
10 hours
2012-08-23
Participant Flow
55 Subjects currently wearing hydrogel or silicone hydrogel lenses were recruited at 3 US and 1 United Kingdom study sites.
Subjects randomized by lens order to wear PureVision and Acuvue 2 lenses for 10 hours each.
Participant milestones
| Measure |
PureVision / Acuvue 2
PureVision lenses worn in Period One, Acuvue 2 lenses worn in Period Two. Both products worn for 10 hours each.
|
Acuvue 2 / PureVision
Acuvue 2 lenses worn in Period One, PureVision lenses worn in Period Two. Both products worn for 10 hours each.
|
|---|---|---|
|
Period One, 10 Hours of Wear
STARTED
|
27
|
28
|
|
Period One, 10 Hours of Wear
COMPLETED
|
27
|
28
|
|
Period One, 10 Hours of Wear
NOT COMPLETED
|
0
|
0
|
|
Period Two, 10 Hours of Wear
STARTED
|
27
|
28
|
|
Period Two, 10 Hours of Wear
COMPLETED
|
27
|
28
|
|
Period Two, 10 Hours of Wear
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Deposits on Contact Lenses Worn Daily Wear
Baseline characteristics by cohort
| Measure |
Overall
n=55 Participants
All enrolled participants
|
|---|---|
|
Age Continuous
|
31.95 years
STANDARD_DEVIATION 12.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 hoursPopulation: All enrolled participants.
Film and discrete deposits were assessed with a slit-lamp after 10 hours of lens wear. Film deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=slight, deposition occupying 1-5% of lens front surface; 2=mild, deposition occupying 6-15% of lens front surface; 3=moderate, deposition occupying 16-25% of lens front surface; 4=severe, deposition occupying \>25% of lens front surface. Discrete deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=microdeposits (less than or equal to 10 dots); 2=microdeposits (greater than 10 dots); 3=macro deposits; 4=one or more jelly bumps. Participants were classified into Front Surface Lens Deposits \<2 (less than grade 2 for both film and discrete) and into front surface lens deposits \>1 (greater than grade 1 for either film, discrete, or both).
Outcome measures
| Measure |
PureVision Contact Lenses
n=55 Participants
PureVision lenses worn 10 hours
|
Acuvue 2 Contact Lenses
n=55 Participants
Acuvue 2 lenses worn 10 hours
|
|---|---|---|
|
Front Surface Lens Deposits
Deposits Graded <2
|
27 Participants
|
32 Participants
|
|
Front Surface Lens Deposits
Deposits Graded >1
|
28 Participants
|
23 Participants
|
Adverse Events
PureVision Lenses Worn 10 Hours
Acuvue 2 Lenses Worn 10 Hours
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
- Publication restrictions are in place
Restriction type: LTE60