Trial Outcomes & Findings for Clinical Performance of a Silicone Hydrogel Lens With Use of FID 114675A (NCT NCT01240135)
NCT ID: NCT01240135
Last Updated: 2012-07-12
Results Overview
As assessed by the investigator using a composite score based on three lens fit measures: static, push-up, and centration. Static and pushup were assessed on a 5-point scale, where -2=reduced movement unacceptable, -1=reduced movement acceptable, 0=optimal movement, 1=excessive movement acceptable, 2=excessive movement unacceptable. Centration was assessed on a 3-point scale, where 0=optimal lens centration, 1=acceptable decentration, 2=unacceptable decentration. A subject with an assessment of optimal or acceptable for each measure was considered acceptable on all measurements.
COMPLETED
NA
89 participants
Day 14 of lens wear
2012-07-12
Participant Flow
Subjects were recruited from 5 US study centers.
Participant milestones
| Measure |
FID 114576A / Renu Fresh
FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.
|
Renu Fresh / FID 114675A
Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.
|
|---|---|---|
|
Period One, 14 Days of Wear
STARTED
|
44
|
45
|
|
Period One, 14 Days of Wear
COMPLETED
|
44
|
45
|
|
Period One, 14 Days of Wear
NOT COMPLETED
|
0
|
0
|
|
Period Two, 14 Days of Wear
STARTED
|
44
|
45
|
|
Period Two, 14 Days of Wear
COMPLETED
|
43
|
43
|
|
Period Two, 14 Days of Wear
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
FID 114576A / Renu Fresh
FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.
|
Renu Fresh / FID 114675A
Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.
|
|---|---|---|
|
Period Two, 14 Days of Wear
Withdrawal by Subject
|
1
|
1
|
|
Period Two, 14 Days of Wear
Adverse Event
|
0
|
1
|
Baseline Characteristics
Clinical Performance of a Silicone Hydrogel Lens With Use of FID 114675A
Baseline characteristics by cohort
| Measure |
FID 114576A / Renu Fresh
n=44 Participants
FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.
|
Renu Fresh / FID 114675A
n=45 Participants
Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
34.3 years
STANDARD_DEVIATION 11.44 • n=5 Participants
|
31.4 years
STANDARD_DEVIATION 9.71 • n=7 Participants
|
32.8 years
STANDARD_DEVIATION 10.64 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 14 of lens wearPopulation: Intent to treat: All randomized subjects with at least one post-baseline assessment after dispensing, according to randomized treatment.
As assessed by the investigator using a composite score based on three lens fit measures: static, push-up, and centration. Static and pushup were assessed on a 5-point scale, where -2=reduced movement unacceptable, -1=reduced movement acceptable, 0=optimal movement, 1=excessive movement acceptable, 2=excessive movement unacceptable. Centration was assessed on a 3-point scale, where 0=optimal lens centration, 1=acceptable decentration, 2=unacceptable decentration. A subject with an assessment of optimal or acceptable for each measure was considered acceptable on all measurements.
Outcome measures
| Measure |
FID 114576A
n=87 Participants
FID 114675A used for contact lens care per protocol-specified instructions for 14 days.
|
Renu Fresh
n=88 Participants
Renu fresh used for contact lens care per protocol-specified instructions for 14 days.
|
|---|---|---|
|
Lens Fit
|
100 percentage of acceptable fit
|
100 percentage of acceptable fit
|
SECONDARY outcome
Timeframe: Day 14 of lens wearPopulation: Intent to treat: All randomized subjects with at least one post-baseline assessment after dispensing, according to randomized treatment.
The bulbar conjunctiva was assessed by the investigator at baseline and Day 14 utilizing a slit-lamp and ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 5-point photographic reference scale, where 0=0.00% coverage and 4=10% or greater coverage. The scores for the four regions were summed, with a sum score range of 0-16.
Outcome measures
| Measure |
FID 114576A
n=87 Participants
FID 114675A used for contact lens care per protocol-specified instructions for 14 days.
|
Renu Fresh
n=88 Participants
Renu fresh used for contact lens care per protocol-specified instructions for 14 days.
|
|---|---|---|
|
Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score
|
0.6 units on a scale
Standard Deviation 2.49
|
1.4 units on a scale
Standard Deviation 2.63
|
Adverse Events
FID 114576A
Renu Fresh
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