Trial Outcomes & Findings for Clinical Performance of a New Daily Disposable Contact Lens Worn in an Established Contact Lens Wearing Population (NCT NCT00708643)
NCT ID: NCT00708643
Last Updated: 2015-05-21
Results Overview
Measures the redness of the limbal region of the eye on a scale of 0 to 100 grade with 0=none and 100=severe. The analysis is the average grade over all time frames.
COMPLETED
NA
80 participants
At 2 weeks and 4 weeks
2015-05-21
Participant Flow
Participant milestones
| Measure |
Habitual Silicone Hydrogel
Habitual contact lens wear.
|
Narafilcon A
Silicone hydrogel daily disposable contact lens
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Habitual Silicone Hydrogel
Habitual contact lens wear.
|
Narafilcon A
Silicone hydrogel daily disposable contact lens
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Clinical Performance of a New Daily Disposable Contact Lens Worn in an Established Contact Lens Wearing Population
Baseline characteristics by cohort
| Measure |
Habitual Silicone Hydrogel
n=40 Participants
Habitual contact lens wear.
|
Narafilcon A
n=40 Participants
Silicone hydrogel daily disposable contact lens
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.3 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
25.8 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
27.2 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Gender
Female
|
32 participants
n=5 Participants
|
33 participants
n=7 Participants
|
65 participants
n=5 Participants
|
|
Gender
Male
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
40 participants
n=5 Participants
|
39 participants
n=7 Participants
|
79 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 2 weeks and 4 weeksPopulation: The analysis includes all subjects that completed the study.
Measures the redness of the limbal region of the eye on a scale of 0 to 100 grade with 0=none and 100=severe. The analysis is the average grade over all time frames.
Outcome measures
| Measure |
Habitual Silicone Hydrogel
n=40 Participants
Habitual contact lens wear.
|
Narafilcon A
n=39 Participants
Silicone hydrogel daily disposable contact lens
|
|---|---|---|
|
Limbal Hyperemia
|
34.0967 units on a scale
Standard Error 1.4982
|
31.0920 units on a scale
Standard Error 1.7271
|
PRIMARY outcome
Timeframe: At 3,7,10,13,17,21,24, and 27 daysPopulation: The analysis includes all subjects that completed the study.
Rating of lens comfort by rating agreement to the following statement: "The lenses I am wearing are comfortable." Rating using the following scale: 1=strongly agree, 2=agree, 3=neutral, 4=disagree, 5=strongly disagree. The rating is averaged over all time frames.
Outcome measures
| Measure |
Habitual Silicone Hydrogel
n=40 Participants
Habitual contact lens wear.
|
Narafilcon A
n=39 Participants
Silicone hydrogel daily disposable contact lens
|
|---|---|---|
|
Lens Comfort
|
1.1078 units on a scale
Standard Error 0.4993
|
1.0274 units on a scale
Standard Error 0.5737
|
PRIMARY outcome
Timeframe: At 2 weeks and 4 weeks.Population: The analysis includes all subjects that completed the study.
Measures the trauma to tissue that lines the margin of the inside of the upper eyelid on a 0 to 3 scale, with 0=none to 3=severe. The analysis is the average grade over all time frames.
Outcome measures
| Measure |
Habitual Silicone Hydrogel
n=40 Participants
Habitual contact lens wear.
|
Narafilcon A
n=39 Participants
Silicone hydrogel daily disposable contact lens
|
|---|---|---|
|
Upper Lid Margin Staining
|
0.9358 units on a scale.
Standard Error 1.1146
|
1.1586 units on a scale.
Standard Error 1.2857
|
SECONDARY outcome
Timeframe: At 2 weeks and 4 weeksPopulation: The analysis includes all subjects that completed the study.
Measures the amount of roughness to the tissue of the inside upper and lower eyelid on a scale of 0 to 100 with 0=none and 100=severe. The analysis is the average grade over all time frames.
Outcome measures
| Measure |
Habitual Silicone Hydrogel
n=40 Participants
Habitual contact lens wear.
|
Narafilcon A
n=39 Participants
Silicone hydrogel daily disposable contact lens
|
|---|---|---|
|
Tarsal Roughness
|
30.1028 units on a scale
Standard Error 0.7784
|
31.3624 units on a scale
Standard Error 0.8994
|
SECONDARY outcome
Timeframe: At 2 weeks and 4 weeks.Population: The analysis includes all subjects that completed the study.
Measures the amount of redness to the tissue of the inside upper and lower eyelid using a 0 to 100 scale with 0=none and 100=severe.
Outcome measures
| Measure |
Habitual Silicone Hydrogel
n=40 Participants
Habitual contact lens wear.
|
Narafilcon A
n=39 Participants
Silicone hydrogel daily disposable contact lens
|
|---|---|---|
|
Tarsal Hyperemia
|
38.4103 units on a scale
Standard Error 1.5238
|
37.5478 units on a scale
Standard Error 1.7646
|
SECONDARY outcome
Timeframe: At 2 weeks and 4 weeks.A measure of corneal abrasion using a 0 to 100 scale with 0=none, 25=micropunctate, 50=macropunctate, 75=coalescence, 100=patch. The analysis is the average grade over all time frames.
Outcome measures
| Measure |
Habitual Silicone Hydrogel
n=40 Participants
Habitual contact lens wear.
|
Narafilcon A
n=39 Participants
Silicone hydrogel daily disposable contact lens
|
|---|---|---|
|
Corneal Staining
|
6.6173 units on a scale
Standard Error 1.1106
|
6.3763 units on a scale
Standard Error 1.2820
|
Adverse Events
Habitual Silicone Hydrogel
Narafilcon A
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kurt Moody, O.D. FAOO
Vistakon
Results disclosure agreements
- Principal investigator is a sponsor employee The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.
- Publication restrictions are in place
Restriction type: OTHER