MedDataX Logo

Trial Outcomes & Findings for A Comparison of Daily Disposable Contact Lenses. (NCT NCT00727558)

NCT ID: NCT00727558

Last Updated: 2015-05-21

Results Overview

Single question: Comfort scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

248 participants

Primary outcome timeframe

at 1 week of wear.

Results posted on

2015-05-21

Participant Flow

Participant milestones

Participant milestones
Measure
Narafilcon A
soft contact lens worn as a daily disposable modality for one week
Nelfilcon A
soft contact lens worn as a daily disposable modality for one week
Overall Study
STARTED
127
121
Overall Study
COMPLETED
125
118
Overall Study
NOT COMPLETED
2
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Narafilcon A
soft contact lens worn as a daily disposable modality for one week
Nelfilcon A
soft contact lens worn as a daily disposable modality for one week
Overall Study
Lens issue
0
1
Overall Study
Adverse Event
0
1
Overall Study
Subject unable to return for follow-up
1
1
Overall Study
Lost to Follow-up
1
0

Baseline Characteristics

A Comparison of Daily Disposable Contact Lenses.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Narafilcon A
n=125 Participants
soft contact lens worn as a daily disposable modality for one week
Nelfilcon A
n=118 Participants
soft contact lens worn as a daily disposable modality for one week
Total
n=243 Participants
Total of all reporting groups
Age, Continuous
33.0 years
STANDARD_DEVIATION 9.5 • n=5 Participants
32.9 years
STANDARD_DEVIATION 10.6 • n=7 Participants
33.0 years
STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male
Female
90 Participants
n=5 Participants
92 Participants
n=7 Participants
182 Participants
n=5 Participants
Sex: Female, Male
Male
35 Participants
n=5 Participants
26 Participants
n=7 Participants
61 Participants
n=5 Participants
Region of Enrollment
United Kingdom
125 participants
n=5 Participants
118 participants
n=7 Participants
243 participants
n=5 Participants

PRIMARY outcome

Timeframe: at 1 week of wear.

Population: Analysis includes participants who completed the protocol and had no missing data (n=240)

Single question: Comfort scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent

Outcome measures

Outcome measures
Measure
Narafilcon A
n=124 Participants
soft contact lens worn as a daily disposable modality for one week
Nelfilcon A
n=116 Participants
soft contact lens worn as a daily disposable modality for one week
Overall Comfort
3.903 Units on a scale
Standard Error 0.1446
3.349 Units on a scale
Standard Error 0.1389

PRIMARY outcome

Timeframe: at 1 week of wear.

Population: Analysis includes participants who completed the study per protocol and had no missing data (n=243).

Measurement of redness of the limbus, graded using half-grade increments using the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.

Outcome measures

Outcome measures
Measure
Narafilcon A
n=125 Participants
soft contact lens worn as a daily disposable modality for one week
Nelfilcon A
n=118 Participants
soft contact lens worn as a daily disposable modality for one week
Measured Limbal Hyperemia
0.364 Units on a scale
Standard Error 0.05494
0.5374 Units on a scale
Standard Error 0.0558

SECONDARY outcome

Timeframe: at 1 week of wear

Population: Analysis includes participants who completed the study per protocol and had no missing data (n=240).

Rating of overall ease of handling using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent.

Outcome measures

Outcome measures
Measure
Narafilcon A
n=124 Participants
soft contact lens worn as a daily disposable modality for one week
Nelfilcon A
n=116 Participants
soft contact lens worn as a daily disposable modality for one week
Overall Handling
4.0959 Units on a scale
Standard Error 0.1209
3.6991 Units on a scale
Standard Error 0.1172

SECONDARY outcome

Timeframe: at 1 week wear

Population: Analysis includes participants who completed the study per protocol and had no missing data.

Rating of "How comfortable did your eyes feel at the end of the day when wearing the contact lenses provided" using the following scale: 1=extremely uncomfortable, 2= very uncomfortable, 3=slightly uncomfortable, 4=comfortable, 5=very comfortable.

Outcome measures

Outcome measures
Measure
Narafilcon A
n=124 Participants
soft contact lens worn as a daily disposable modality for one week
Nelfilcon A
n=116 Participants
soft contact lens worn as a daily disposable modality for one week
How Comfortable Eyes Feel at the End of the Day
3.8669 Units on a scale
Standard Error 0.1546
3.4794 Units on a scale
Standard Error 0.1487

SECONDARY outcome

Timeframe: at 1 week of wear

Population: Analysis includes participants who completed the study per protocol and had no missing data (n=240).

Rating of comfort at the end of the day using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent

Outcome measures

Outcome measures
Measure
Narafilcon A
n=124 Participants
soft contact lens worn as a daily disposable modality for one week
Nelfilcon A
n=116 Participants
soft contact lens worn as a daily disposable modality for one week
End of Day Comfort
3.425 Units on a scale
Standard Error 0.129
2.7515 Units on a scale
Standard Error 0.1269

SECONDARY outcome

Timeframe: at 1 week

Population: Analysis includes participants who completed the study per protocol and had no missing data (n=240).

Rating of "comfort immediately when you first put them on" using the following scale: 0=N/A, 1= Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent.

Outcome measures

Outcome measures
Measure
Narafilcon A
n=124 Participants
soft contact lens worn as a daily disposable modality for one week
Nelfilcon A
n=116 Participants
soft contact lens worn as a daily disposable modality for one week
Initial Comfort
4.0306 Units on a scale
Standard Error 0.1352
3.8986 Units on a scale
Standard Error 0.1312

SECONDARY outcome

Timeframe: at 1 week of wear

Population: Analysis includes participants who completed the study per protocol and had no missing data (n=243).

National Eye Institute (NEI) 0-3 scale: grade 0=normal, grade 1=mild, grade 2=moderate, grade 3=severe.

Outcome measures

Outcome measures
Measure
Narafilcon A
n=125 Participants
soft contact lens worn as a daily disposable modality for one week
Nelfilcon A
n=118 Participants
soft contact lens worn as a daily disposable modality for one week
Inferior Region Corneal Staining
0.311 Units on a scale
Standard Error 0.03884
0.5579 Units on a scale
Standard Error 0.03974

Adverse Events

Narafilcon A

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Nelfilcon A

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kurt Moody OD, FAAO/ Director

Vistakon

Phone: 904-443-3088

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