Trial Outcomes & Findings for Comparative Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions (NCT NCT01024855)
NCT ID: NCT01024855
Last Updated: 2015-10-20
Results Overview
Subjects examined after corneal staining (a method used to assess the condition of the cornea) using a slit lamp to determine change from baseline and rated based on the following scale: 0=no change from baseline, 1=trace, 2=mild, 3=moderate, 4=severe.
COMPLETED
PHASE1/PHASE2
30 participants
Change from baseline after 1, 2, 4 and 6+ hours of wear
2015-10-20
Participant Flow
Recruitment of employees occurred 7/8/2010 - 10/1/2010 thru employee bulletin for study taking place at in-house optometric clinic.
Prior to baseline visit subjects were instructed to undergo a "washout period" where no contacts were worn for 12 hours. Slit lamp exam was conducted prior to randomized group assignment. Eyes were thoroughly rinsed with unit-dose aline before pre-soaked study lenses were inserted.
Participant milestones
| Measure |
RevitaLens and OptiFree
30 subjects, one eye received RevitaLens MPS (investigational), one eye received Opti-Free RepleniSH MPS(control).
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
RevitaLens and OptiFree
30 subjects, one eye received RevitaLens MPS (investigational), one eye received Opti-Free RepleniSH MPS(control).
|
|---|---|
|
Overall Study
Inclusion/exclusion criteria
|
1
|
Baseline Characteristics
Comparative Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions
Baseline characteristics by cohort
| Measure |
RevitaLens and OptiFree
n=30 Participants
30 subjects, one eye received RevitaLens MPS (investigational), one eye received Opti-Free RepleniSH MPS(control).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex/Gender, Customized
Unknown
|
30 participants
n=99 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Change from baseline after 1, 2, 4 and 6+ hours of wearPopulation: per protocol
Subjects examined after corneal staining (a method used to assess the condition of the cornea) using a slit lamp to determine change from baseline and rated based on the following scale: 0=no change from baseline, 1=trace, 2=mild, 3=moderate, 4=severe.
Outcome measures
| Measure |
RevitaLens
n=30 Participants
30 subjects, one eye received RevitaLens MPS (investigational).
|
OptiFree
n=30 Participants
30 subjects, one eye received Opti-Free RepleniSH MPS(control).
|
|---|---|---|
|
Number of Eyes With No Change in Corneal Staining
1 Hour - No Change
|
16 eyes
|
17 eyes
|
|
Number of Eyes With No Change in Corneal Staining
2 Hours - No Change
|
19 eyes
|
14 eyes
|
|
Number of Eyes With No Change in Corneal Staining
4 Hours - No Change
|
21 eyes
|
21 eyes
|
|
Number of Eyes With No Change in Corneal Staining
End of Day (>6 hrs) - No Change
|
19 eyes
|
20 eyes
|
Adverse Events
RevitaLens and OptiFree
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Nick Tarantino, Head, Clinical Research and Development
Abbott Medical Optics, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place