Trial Outcomes & Findings for Evaluation of a New Silicone Hydrogel Contact Lens (NCT NCT01309880)
NCT ID: NCT01309880
Last Updated: 2015-02-23
Results Overview
Distance high contrast logMAR lens visual acuity (VA) between the Air Optix Aqua lens and the Test Lens at Dispensing and at 1-Week Follow-up.
COMPLETED
NA
66 participants
Dispensing & 1-week follow up
2015-02-23
Participant Flow
This study was a randomized, bilateral, subject-masked, two-week study with a crossover at one week, conducted at three sites in the United States (US). First participant was enrolled on 12/01/2010, last participant exited the study on 12/23/2010.
A total of 66 participants (132 eyes) were enrolled in the study. One-half (33) were randomized to receive the investigational RD2117-01 ID4 contact lens first, and the other half (33) was randomized to receive the Air Optix Aqua contact lens first then crossed over after 1 week. All participants completed the study.
Participant milestones
| Measure |
Air Optix Aqua Then Test Lens
Ciba Vision Air Optix Aqua contact lens. Lenses were worn on a daily wear basis. After one week participants crossed over to the Test lens. All subjects were provided with Bausch + Lomb renu® fresh™ multi-purpose solution and lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses, and Bausch + Lomb Sensitive Eyes® Rewetting Drops for use as needed during the study.
|
Test Lens Then Air Optix Aqua
The test lens was an Investigational silicone hydrogel contact lens. Lenses were worn on a daily wear basis. After one week participants crossed over to Ciba Vision Air Optix Aqua contact lens.. All subjects were provided with Bausch + Lomb renu® fresh™ multi-purpose solution and lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses, and Bausch + Lomb Sensitive Eyes® Rewetting Drops for use as needed during the study.
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|---|---|---|
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Overall Study
STARTED
|
33
|
33
|
|
Overall Study
COMPLETED
|
33
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of a New Silicone Hydrogel Contact Lens
Baseline characteristics by cohort
| Measure |
Overall Study
n=66 Participants
One-half of the participants (33) were randomized to receive the investigational RD2117-01 ID4 contact lens, and the other half (33) was randomized to receive the Air Optix Aqua contact lens. Both groups wore the lenses on a daily wear basis. After one week of wearing the first lens type, the subjects returned for an exam and crossed over to the second lens type for one week.
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|---|---|
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Age, Continuous
|
36.2 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
66 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Dispensing & 1-week follow upPopulation: All Eligible, Dispensed Eyes
Distance high contrast logMAR lens visual acuity (VA) between the Air Optix Aqua lens and the Test Lens at Dispensing and at 1-Week Follow-up.
Outcome measures
| Measure |
Air Optix Aqua
n=132 eyes
Ciba Vision daily wear contact lens
Air Optix Aqua: Air Optix Aqua contact lens worn on a daily wear basis
|
Test Lens
n=132 eyes
Investigational silicone hydrogel contact lens
Test lens: Investigational silicone hydrogel contact lens worn on a daily wear basis
|
|---|---|---|
|
Visual Acuity
Dispensing
|
-0.083 logMAR
Standard Deviation 0.071
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-0.085 logMAR
Standard Deviation 0.071
|
|
Visual Acuity
1-Week Follow-up
|
-0.084 logMAR
Standard Deviation 0.077
|
-0.078 logMAR
Standard Deviation 0.077
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SECONDARY outcome
Timeframe: 1 weekPopulation: All Dispensed Eyes
Measured on a scale of 0-4 where 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe for edema, microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization and corneal infiltrates.
Outcome measures
| Measure |
Air Optix Aqua
n=132 eyes
Ciba Vision daily wear contact lens
Air Optix Aqua: Air Optix Aqua contact lens worn on a daily wear basis
|
Test Lens
n=132 eyes
Investigational silicone hydrogel contact lens
Test lens: Investigational silicone hydrogel contact lens worn on a daily wear basis
|
|---|---|---|
|
Slit Lamp Findings
Grade 1
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86 eyes
|
50 eyes
|
|
Slit Lamp Findings
Grade 0
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46 eyes
|
82 eyes
|
|
Slit Lamp Findings
Grade 2
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0 eyes
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0 eyes
|
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Slit Lamp Findings
> Grade 2
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0 eyes
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0 eyes
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SECONDARY outcome
Timeframe: 1 WeeksAt 1-Week Follow-up, participants rated lens comfort on a scale of 0 to 100, with 100 being the most favorable score.
Outcome measures
| Measure |
Air Optix Aqua
n=66 Participants
Ciba Vision daily wear contact lens
Air Optix Aqua: Air Optix Aqua contact lens worn on a daily wear basis
|
Test Lens
n=132 eyes
Investigational silicone hydrogel contact lens
Test lens: Investigational silicone hydrogel contact lens worn on a daily wear basis
|
|---|---|---|
|
Comfort
|
85.5 units on a scale
Standard Deviation 19.5
|
81.8 units on a scale
Standard Deviation 19.5
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Adverse Events
Air Optix Aqua
Test Lens
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: OTHER