Trial Outcomes & Findings for A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens (NCT NCT01412983)
NCT ID: NCT01412983
Last Updated: 2014-04-29
Results Overview
The mean difference in high contrast logMAR, over all lens visual acuities (VAs) between lens groups.
COMPLETED
NA
100 participants
One week
2014-04-29
Participant Flow
This study was conducted at 5 clinical sites in the US. First participant was enrolled 08/08/2011 and last participant exited on 09/01/2011.
100 participants (200 eyes) were enrolled in this 2 week crossover study. Participants were divided into 2 groups wearing one study lens for 1 week and then crossing over to the other study lens for 1 week. 96 participants completed the study, 1 participant was ineligible at baseline while 3 participants were discontinued during the study.
Participant milestones
| Measure |
Bausch+Lomb Test Lens Then Ciba Vision Lens
Bausch+Lomb investigational soft contact lens
Bausch+Lomb Test lens:Ciba Vision Lens. Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses.
|
Ciba Vision Soft Contact Lens Then Bausch+Lomb Test Lens
Ciba Vision Air Optix Aqua soft contact lens
Ciba Vision lens:Bausch+Lomb Test Lens. Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses.
|
|---|---|---|
|
1st Period
STARTED
|
50
|
50
|
|
1st Period
COMPLETED
|
50
|
46
|
|
1st Period
NOT COMPLETED
|
0
|
4
|
|
2nd Period
STARTED
|
50
|
46
|
|
2nd Period
COMPLETED
|
50
|
46
|
|
2nd Period
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Bausch+Lomb Test Lens Then Ciba Vision Lens
Bausch+Lomb investigational soft contact lens
Bausch+Lomb Test lens:Ciba Vision Lens. Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses.
|
Ciba Vision Soft Contact Lens Then Bausch+Lomb Test Lens
Ciba Vision Air Optix Aqua soft contact lens
Ciba Vision lens:Bausch+Lomb Test Lens. Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses.
|
|---|---|---|
|
1st Period
Ineligible
|
0
|
1
|
|
1st Period
Positive slit lamp finding
|
0
|
1
|
|
1st Period
Unacceptable lens movement
|
0
|
1
|
|
1st Period
Inability to maintain wear
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens
Baseline characteristics by cohort
| Measure |
Overall Study
n=99 Participants
All 99 participants in study
|
|---|---|
|
Age, Continuous
|
29.9 years
STANDARD_DEVIATION 7.6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
94 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
99 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: One weekPopulation: All eligible dispensed eyes
The mean difference in high contrast logMAR, over all lens visual acuities (VAs) between lens groups.
Outcome measures
| Measure |
Bausch+Lomb Test Lens
n=192 eyes
Bausch+Lomb investigational soft contact lens
Bausch+Lomb Test lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch+Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses.
|
Ciba Vision Soft Contact Lens
n=190 eyes
Ciba Vision Air Optix Aqua soft contact lens
Ciba Vision soft contact lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses.
|
|---|---|---|
|
Visual Acuity
|
-0.054 LogMAR
Standard Deviation 0.115
|
-0.051 LogMAR
Standard Deviation 0.115
|
SECONDARY outcome
Timeframe: One weekPopulation: All eligible dispensed eyes
The mean difference in comfort-related symptoms/complaints scores between lens groups. Rated on a scale of 0-100 with 100 being the most favorable score.
Outcome measures
| Measure |
Bausch+Lomb Test Lens
n=192 Eyes
Bausch+Lomb investigational soft contact lens
Bausch+Lomb Test lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch+Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses.
|
Ciba Vision Soft Contact Lens
n=194 Eyes
Ciba Vision Air Optix Aqua soft contact lens
Ciba Vision soft contact lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses.
|
|---|---|---|
|
Overall Comfort
|
81.9 units on a scale
Standard Deviation 21.7
|
82.7 units on a scale
Standard Deviation 21.8
|
Adverse Events
Bausch & Lomb Test Lens
Ciba Vision Soft Contact 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