Trial Outcomes & Findings for A Study to Evaluate the Product Feasibility of Two New Silicone Hydrogel Contact Lenses (NCT NCT01583868)
NCT ID: NCT01583868
Last Updated: 2020-10-22
Results Overview
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
216 participants
Primary outcome timeframe
At 1 week follow up
Results posted on
2020-10-22
Participant Flow
This was a randomized, bilateral, study, with a crossover at one week and a second crossover at two weeks. A total of 216 subjects (432 eyes) were enrolled in this study. Participants were randomized to receive either, the Test Lens C, Test Lens D and PureVision2 lenses, or the Test Lens C, Test Lens D and Air Optix Aqua lenses.
Participant milestones
| Measure |
B&L RD2135-01 Lens C Then B&L RD2135-01 Lens D Then PureVision
B\&L RD2135-01 Lens C for one week then B\&L RD2135-01 Lens D for one week then PureVision2 for one week
|
B&L RD2135-01 Lens C Then B&L RD2135-01 Lens D Then Ciba Vis
B\&L RD2135-01 Lens C for one week then B\&L RD2135-01 Lens D for one week then Ciba Vision for one week
|
|---|---|---|
|
Overall Study
STARTED
|
108
|
108
|
|
Overall Study
COMPLETED
|
104
|
104
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Product Feasibility of Two New Silicone Hydrogel Contact Lenses
Baseline characteristics by cohort
| Measure |
B&L RD2135-01 Lens C Then B&L RD2135-01 Lens D Then PureVision
n=105 Participants
B\&L RD2135-01 Lens C for one week then B\&L RD2135-01 Lens D for one week then PureVision2 for one week
|
B&L RD2135-01 Lens C Then B&L RD2135-01 Lens D Then Ciba Vis
n=105 Participants
B\&L RD2135-01 Lens C for one week then B\&L RD2135-01 Lens D for one week then Ciba Vision for one week
|
Total
n=210 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.3 years
STANDARD_DEVIATION 8.55 • n=5 Participants
|
31.8 years
STANDARD_DEVIATION 8.68 • n=7 Participants
|
31.5 years
STANDARD_DEVIATION 8.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 1 week follow upPopulation: There were 212 eligible, dispensed participants (424 eyes). Participants/eyes received multiple treatment groups in this cross-over study. All eyes received investigational lens C and investigation lens D. Half of the eyes received PureVision2 and half of the eyes received Ciba Vision Air Optix Aqua.
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
Outcome measures
| Measure |
B&L RD2135-01 Lens C
n=424 eyes
Investigational Silicone hydrogel soft contact lens
B\&L RD2135-01 lens C: Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
|
B&L RD2135-01 Lens D
n=424 eyes
Investigational Silicone hydrogel soft contact lens
B\&L RD2135-01 lens D: Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
|
PureVision2
n=212 eyes
Bausch \& Lomb High definition soft contact lenses
PureVision2: Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
|
Ciba Vision Air Optix Aqua
n=212 eyes
Ciba Vision Air Optix Aqua soft contact lens
Air Optix Aqua: Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
|
|---|---|---|---|---|
|
Visual Acuity
|
-0.089 logMAR
Standard Deviation 0.078
|
-0.087 logMAR
Standard Deviation 0.079
|
-0.086 logMAR
Standard Deviation 0.077
|
-0.086 logMAR
Standard Deviation 0.082
|
SECONDARY outcome
Timeframe: At 1 Week follow upPopulation: There were 212 eligible, dispensed participants (424 eyes). Participants/eyes received multiple treatment groups in this cross-over study. All eyes received investigational lens C and investigation lens D. Half of the eyes received PureVision2 and half of the eyes received Ciba Vision Air Optix Aqua.
Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. Symptoms/complaints were recorded for each eye based on the participant's experience with their study lenses worn for that respective treatment period. Symptoms/complaints parameters included the following: Burning/stinging upon insertion, Comfort upon insertion, Overall comfort, Comfort at end of day, Ease of handling/insertion, Ease of handling/removal, Dryness, Itchiness, Redness, Vision upon insertion, Vision, Vision in low light, Lens cleanness upon insertion, Lens cleanness upon removal, Lens cleanness, Dryness at end of day, and Overall impression.
Outcome measures
| Measure |
B&L RD2135-01 Lens C
n=212 Participants
Investigational Silicone hydrogel soft contact lens
B\&L RD2135-01 lens C: Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
|
B&L RD2135-01 Lens D
n=424 eyes
Investigational Silicone hydrogel soft contact lens
B\&L RD2135-01 lens D: Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
|
PureVision2
n=212 eyes
Bausch \& Lomb High definition soft contact lenses
PureVision2: Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
|
Ciba Vision Air Optix Aqua
n=212 eyes
Ciba Vision Air Optix Aqua soft contact lens
Air Optix Aqua: Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
|
|---|---|---|---|---|
|
Symptoms and Complaints
Vision in low light
|
91.0 score on a scale
Standard Deviation 11.9
|
89.9 score on a scale
Standard Deviation 13.4
|
87.3 score on a scale
Standard Deviation 13.8
|
91.4 score on a scale
Standard Deviation 12.5
|
|
Symptoms and Complaints
Burning/stinging upon insertion
|
91.3 score on a scale
Standard Deviation 13.1
|
91.3 score on a scale
Standard Deviation 12.4
|
83.1 score on a scale
Standard Deviation 21.4
|
92.6 score on a scale
Standard Deviation 9.9
|
|
Symptoms and Complaints
Comfort upon insertion
|
89.6 score on a scale
Standard Deviation 14.5
|
88.2 score on a scale
Standard Deviation 15.6
|
78.7 score on a scale
Standard Deviation 15.6
|
89.6 score on a scale
Standard Deviation 12.0
|
|
Symptoms and Complaints
Overall comfort
|
88.0 score on a scale
Standard Deviation 14.6
|
85.7 score on a scale
Standard Deviation 16.9
|
78.4 score on a scale
Standard Deviation 20.4
|
86.6 score on a scale
Standard Deviation 15.8
|
|
Symptoms and Complaints
Ease of handling/insertion
|
89.5 score on a scale
Standard Deviation 16.6
|
88.6 score on a scale
Standard Deviation 17.3
|
85.0 score on a scale
Standard Deviation 20.4
|
89.0 score on a scale
Standard Deviation 15.3
|
|
Symptoms and Complaints
Dryness
|
84.4 score on a scale
Standard Deviation 16.1
|
81.9 score on a scale
Standard Deviation 18.1
|
77.0 score on a scale
Standard Deviation 21.6
|
84.4 score on a scale
Standard Deviation 17.3
|
|
Symptoms and Complaints
Vision upon insertion
|
93.4 score on a scale
Standard Deviation 9.6
|
91.5 score on a scale
Standard Deviation 13.3
|
87.0 score on a scale
Standard Deviation 17.5
|
93.1 score on a scale
Standard Deviation 9.6
|
|
Symptoms and Complaints
Vision
|
92.3 score on a scale
Standard Deviation 11.4
|
91.9 score on a scale
Standard Deviation 13.1
|
88.1 score on a scale
Standard Deviation 14.6
|
93.5 score on a scale
Standard Deviation 10.3
|
|
Symptoms and Complaints
Lens cleannes upon removal
|
89.9 score on a scale
Standard Deviation 12.2
|
89.3 score on a scale
Standard Deviation 12.9
|
86.3 score on a scale
Standard Deviation 17.2
|
90.9 score on a scale
Standard Deviation 9.7
|
|
Symptoms and Complaints
Lens cleanness
|
91.8 score on a scale
Standard Deviation 10.6
|
91.2 score on a scale
Standard Deviation 11.7
|
86.6 score on a scale
Standard Deviation 17.0
|
92.5 score on a scale
Standard Deviation 9.1
|
|
Symptoms and Complaints
Dryness at end of day
|
82.4 score on a scale
Standard Deviation 17.7
|
80.3 score on a scale
Standard Deviation 19.3
|
75.5 score on a scale
Standard Deviation 21.7
|
82.4 score on a scale
Standard Deviation 17.3
|
|
Symptoms and Complaints
Overall impression
|
84.5 score on a scale
Standard Deviation 17.0
|
82.2 score on a scale
Standard Deviation 19.0
|
73.7 score on a scale
Standard Deviation 24.6
|
83.9 score on a scale
Standard Deviation 18.3
|
|
Symptoms and Complaints
Comfort at end of day
|
81.2 score on a scale
Standard Deviation 18.9
|
79.3 score on a scale
Standard Deviation 20.2
|
72.0 score on a scale
Standard Deviation 22.9
|
79.7 score on a scale
Standard Deviation 19.7
|
|
Symptoms and Complaints
Ease of handling/removal
|
91.1 score on a scale
Standard Deviation 14.3
|
91.0 score on a scale
Standard Deviation 13.6
|
89.4 score on a scale
Standard Deviation 15.6
|
89.4 score on a scale
Standard Deviation 15.5
|
|
Symptoms and Complaints
Itchiness
|
90.6 score on a scale
Standard Deviation 12.9
|
89.6 score on a scale
Standard Deviation 15.9
|
87.4 score on a scale
Standard Deviation 17.0
|
88.5 score on a scale
Standard Deviation 17.3
|
|
Symptoms and Complaints
Redness
|
92.4 score on a scale
Standard Deviation 11.7
|
91.6 score on a scale
Standard Deviation 13.1
|
90.6 score on a scale
Standard Deviation 14.0
|
91.2 score on a scale
Standard Deviation 12.5
|
|
Symptoms and Complaints
Lens cleanness upon insertion
|
93.1 score on a scale
Standard Deviation 10.9
|
92.8 score on a scale
Standard Deviation 11.4
|
89.7 score on a scale
Standard Deviation 14.6
|
94.4 score on a scale
Standard Deviation 7.7
|
Adverse Events
B&L RD2135-01 Lens C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
B&L RD2135-01 Lens D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PureVision2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ciba Vision Air Optix Aqua
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
Results disclosure agreements
- Principal investigator is a sponsor employee Contact sponsor directly for details.
- Publication restrictions are in place
Restriction type: OTHER