Trial Outcomes & Findings for A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens (NCT NCT01873846)
NCT ID: NCT01873846
Last Updated: 2019-07-24
Results Overview
Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to answer the following question: "How would you say these contact lenses compare overall with the contact lenses you usually use?" Prefer study lenses Prefer usual lenses About the same as usual lenses
COMPLETED
NA
400 participants
7 days
2019-07-24
Participant Flow
Participant milestones
| Measure |
Silicone Hydrogel Contact Lens
Contact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses.
Silicone Hydrogel Contact Lens
|
|---|---|
|
Overall Study
STARTED
|
400
|
|
Overall Study
Eligble Participants Dispensed Lenses
|
396
|
|
Overall Study
COMPLETED
|
388
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens
Baseline characteristics by cohort
| Measure |
Silicone Hydrogel Contact Lens
n=396 Participants
Contact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses.
Silicone Hydrogel Contact Lens
|
|---|---|
|
Age, Continuous
|
26.8 years
STANDARD_DEVIATION 4.8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
278 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
118 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
44 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
327 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: There were 380 eligible subjects with lenses dispensed.
Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to answer the following question: "How would you say these contact lenses compare overall with the contact lenses you usually use?" Prefer study lenses Prefer usual lenses About the same as usual lenses
Outcome measures
| Measure |
Silicone Hydrogel Contact Lens
n=380 Participants
Contact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses.
Silicone Hydrogel Contact Lens
|
|---|---|
|
Preference Question: How Would You Say These Contact Lenses Compare Overall With the Contact Lenses You Usually Use?
Prefer study lenses
|
195 Participants
|
|
Preference Question: How Would You Say These Contact Lenses Compare Overall With the Contact Lenses You Usually Use?
Prefer usual lenses
|
93 Participants
|
|
Preference Question: How Would You Say These Contact Lenses Compare Overall With the Contact Lenses You Usually Use?
About the same as usual lens
|
92 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: There were 380 eligible subjects with lenses dispensed.
Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: "These contact lenses deliver exceptional clarity and comfort all day long." Prefer study lenses Prefer usual lenses About the same as usual lenses
Outcome measures
| Measure |
Silicone Hydrogel Contact Lens
n=380 Participants
Contact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses.
Silicone Hydrogel Contact Lens
|
|---|---|
|
Preference Question: These Contact Lenses Deliver Exceptional Clarity and Comfort All Day Long.
Prefer usual lenses
|
80 Participants
|
|
Preference Question: These Contact Lenses Deliver Exceptional Clarity and Comfort All Day Long.
About the same as usual lens
|
101 Participants
|
|
Preference Question: These Contact Lenses Deliver Exceptional Clarity and Comfort All Day Long.
Prefer study lenses
|
199 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: There were 380 eligible subjects with lenses dispensed.
Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: "These contact lenses help maintain healthy, white eyes." Prefer study lenses Prefer usual lenses About the same as usual lenses
Outcome measures
| Measure |
Silicone Hydrogel Contact Lens
n=380 Participants
Contact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses.
Silicone Hydrogel Contact Lens
|
|---|---|
|
Preference Question: These Contact Lenses Help Maintain Healthy, White Eyes.
Prefer study lenses
|
162 Participants
|
|
Preference Question: These Contact Lenses Help Maintain Healthy, White Eyes.
Prefer usual lenses
|
51 Participants
|
|
Preference Question: These Contact Lenses Help Maintain Healthy, White Eyes.
About the same as usual lens
|
167 Participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: High contrast distance lens visual acuity (VA) was assessed at Screening/Dispensing on the Test (newly dispensed) lenses, and at the follow-up visit(s). The population included subjects with baseline and at least one post-baseline assessment.
High Contrast Distance logMAR Lens VA Change From Baseline to Week 2.
Outcome measures
| Measure |
Silicone Hydrogel Contact Lens
n=764 Eyes
Contact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses.
Silicone Hydrogel Contact Lens
|
|---|---|
|
Lens Performance Assessment
|
0.004 Log of Minimum Angle of Resolution VA
Standard Deviation 0.067
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Percentages are based on the number of dispensed eyes with non-missing scores.
Slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates, were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Corneal staining grades were computed as the maximum grade over grades taken within each of five different eye locations (central, inferior, nasal, superior, and temporal). Eyes with multiple visits are counted once for the highest grade.
Outcome measures
| Measure |
Silicone Hydrogel Contact Lens
n=792 Eyes
Contact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses.
Silicone Hydrogel Contact Lens
|
|---|---|
|
Any Graded Slit Lamp Finding > 2
|
2 Eyes
|
Adverse Events
Silicone Hydrogel 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