Trial Outcomes & Findings for 7-Day, Multi-Site Study of an Investigational Multi-Purpose Disinfecting Solution for Contact Lens Wearers (NCT NCT00884806)
NCT ID: NCT00884806
Last Updated: 2012-03-27
Results Overview
Corneal staining was assessed by the investigator using fluorescein dye, a yellow filter, and a slit lamp. Corneal staining was graded on a continuous scale of 0% (no staining in the region) to 100% (staining covers entire region) in 1% increments for 5 corneal regions (central, nasal, temporal, inferior, and superior). Solution-related corneal staining was defined as ≥20% corneal staining area in at least 3 corneal regions of both eyes.
COMPLETED
NA
110 participants
Day 7
2012-03-27
Participant Flow
Participants were recruited from 6 US study centers.
110 participants with normal eyes (other than vision correction) were enrolled in the study. After the screening visit, particpants discontinued contact lens wear and wore their glasses for at least 2 days as a washout prior to the baseline/dispensing visit.
Participant milestones
| Measure |
FID 114675A
FID 114675A used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel or hydrogel contact lenses, per protocol-specified instructions.
|
|---|---|
|
Overall Study
STARTED
|
110
|
|
Overall Study
COMPLETED
|
110
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
7-Day, Multi-Site Study of an Investigational Multi-Purpose Disinfecting Solution for Contact Lens Wearers
Baseline characteristics by cohort
| Measure |
FID 114675A
n=110 Participants
FID 114675A used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel or hydrogel contact lenses, per protocol-specified instructions.
|
|---|---|
|
Age Continuous
|
33.1 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 7Population: Intent to treat: All participants who received regimen and had at least one on-therapy visit.
Corneal staining was assessed by the investigator using fluorescein dye, a yellow filter, and a slit lamp. Corneal staining was graded on a continuous scale of 0% (no staining in the region) to 100% (staining covers entire region) in 1% increments for 5 corneal regions (central, nasal, temporal, inferior, and superior). Solution-related corneal staining was defined as ≥20% corneal staining area in at least 3 corneal regions of both eyes.
Outcome measures
| Measure |
FID 114675A
n=110 Participants
FID 114675A used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel or hydrogel contact lenses, per protocol-specified instructions.
|
|---|---|
|
Solution-Related Corneal Staining
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 7Population: Intent to treat: All participant who received regimen and had at least one on-therapy study visit.
Lens comfort was assessed by the participant on a 5-point Likert scale prior to any examination. The participant was instructed to select a single response to the statement, "Over the previous 2-3 hours, my lenses felt comfortable," with 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, and 5 = strongly agree.
Outcome measures
| Measure |
FID 114675A
n=28 Participants
FID 114675A used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel or hydrogel contact lenses, per protocol-specified instructions.
|
|---|---|
|
Mean Lens Comfort
|
4.4 Units on a scale
Standard Deviation 0.8
|
Adverse Events
FID 114675A
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 Alcon reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER