Trial Outcomes & Findings for Single Site Study of the Wettability of Contact Lenses With an Investigational Multi-Purpose Disinfecting Solution vs. a Marketed Multi-Purpose Solution (NCT NCT00885092)
NCT ID: NCT00885092
Last Updated: 2012-03-27
Results Overview
Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.
COMPLETED
NA
40 participants
Day 7, Hour 14
2012-03-27
Participant Flow
Participants were recruited from one US study center.
40 participants with normal eyes (other than vision correction) were enrolled in the trial. After the screening visit, participants discontinued contact lens wear and wore their glasses for at least 2 days as a washout prior to Period 1. A similar washout occurred prior to Period 2. Cross-over study design.
Participant milestones
| Measure |
FID 114675A / RepleniSH
FID 114675A in Period 1; RepleniSH in Period 2. Each solution was used for 7 days, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis.
|
RepleniSH / FID 114675A
RepleniSH in Period 1; FID 114675A in Period 2. Each solution was used for 7 days, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis.
|
|---|---|---|
|
Period 1, 7 Days
STARTED
|
20
|
20
|
|
Period 1, 7 Days
COMPLETED
|
20
|
20
|
|
Period 1, 7 Days
NOT COMPLETED
|
0
|
0
|
|
Period 2, 7 Days
STARTED
|
20
|
20
|
|
Period 2, 7 Days
COMPLETED
|
20
|
20
|
|
Period 2, 7 Days
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single Site Study of the Wettability of Contact Lenses With an Investigational Multi-Purpose Disinfecting Solution vs. a Marketed Multi-Purpose Solution
Baseline characteristics by cohort
| Measure |
FID 114675A / RepleniSH
n=20 Participants
FID 114675A in Period 1; RepleniSH in Period 2. Each solution was used for 7 days, per protocol-specified instructions. Contact lenses worn bilaterally on a daily wear basis, with a new pair dispensed at the beginning of each period.
|
RepleniSH / FID 114675A
n=20 Participants
RepleniSH in Period 1; FID 114675A in Period 2. Each solution was used for 7 days, per protocol-specified instructions. Contact lenses worn bilaterally on a daily wear basis, with a new pair dispensed at the beginning of each period.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
42.9 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
42.4 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
42.6 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 7, Hour 14Population: Intent to treat: All participants who received regimen and had at least one on-therapy visit. Cross-over study design.
Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.
Outcome measures
| Measure |
FID 114675A
n=40 Participants
FID 114675A solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
|
RepleniSH
n=40 Participants
Commercially marketed solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
|
|---|---|---|
|
Mean Ex-Vivo Wetting Angle
|
52.1 Degrees
Standard Deviation 32.7
|
59.6 Degrees
Standard Deviation 38.1
|
SECONDARY outcome
Timeframe: Day 7, Hour 14Population: Intent to treat: All participants who received regimen and had at least one on-therapy visit. Cross-over study design.
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, "My lenses feel comfortable right now," with 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, and 5 = strongly agree.
Outcome measures
| Measure |
FID 114675A
n=40 Participants
FID 114675A solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
|
RepleniSH
n=40 Participants
Commercially marketed solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
|
|---|---|---|
|
Mean Lens Comfort
|
4.1 Units on a scale
Standard Deviation 0.9
|
3.8 Units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Day 7, Hour 14Population: Intent to treat: All participants who received regimen and had at least one on-therapy visit. Cross-over study design.
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 and is reported as a percentage of total participants.
Outcome measures
| Measure |
FID 114675A
n=40 Participants
FID 114675A solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
|
RepleniSH
n=40 Participants
Commercially marketed solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
|
|---|---|---|
|
Percentage of Participants With Solution-Related Corneal Staining
|
0 Percentage of participants
|
0 Percentage of participants
|
Adverse Events
FID 114675A
RepleniSH
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