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Trial Outcomes & Findings for In-office Evaluation of Two Toric Soft Contact Lenses and a Spherical Soft Contact Lens (NCT NCT00584727)

NCT ID: NCT00584727

Last Updated: 2015-05-21

Results Overview

Number of eyes with Distance Visual Acuity 20/20 or better

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

96 participants

Primary outcome timeframe

15-20 minutes

Results posted on

2015-05-21

Participant Flow

Participant milestones

Participant milestones
Measure
Senofilcon A/Alphafilcon A/Etafilcon A
First Intervention: senofilcon A toric contact lenses Second Intervention: alphafilcon A toric contact lenses Third Intervention: etafilcon A sphere contact lenses
Alphafilcon A/Etafilcon A/Senofilcon A
First Intervention: alphafilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: senofilcon A toric contact lenses
Etafilcon A/Senofilcon A/Alphafilcon A
First Intervention: etafilcon A sphere contact lenses Second Intervention: senofilcon A toric contact lenses Third Intervention: alphafilcon A toric contact lenses
Senofilcon A/Etafilcon A/Alphafilcon A
First Intervention: senofilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: alphafilcon A toric contact lenses
Alphafilcon A/Senofilcon A/Etafilcon A
First intervention: alphafilcon A toric Second intervention: senofilcon A toric Third intervention: etafilcon A sphere
Etafilcon A/Alphafilcon A/Senofilcon A
First intervention: etafilcon A sphere contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: senofilcon A toric contact lenses
First Intervention
STARTED
17
17
16
14
16
16
First Intervention
COMPLETED
17
17
15
14
16
16
First Intervention
NOT COMPLETED
0
0
1
0
0
0
Second Intervention
STARTED
17
17
15
14
16
16
Second Intervention
COMPLETED
17
17
15
14
16
16
Second Intervention
NOT COMPLETED
0
0
0
0
0
0
Third Intervention
STARTED
17
17
15
14
16
16
Third Intervention
COMPLETED
17
17
14
14
12
14
Third Intervention
NOT COMPLETED
0
0
1
0
4
2

Reasons for withdrawal

Reasons for withdrawal
Measure
Senofilcon A/Alphafilcon A/Etafilcon A
First Intervention: senofilcon A toric contact lenses Second Intervention: alphafilcon A toric contact lenses Third Intervention: etafilcon A sphere contact lenses
Alphafilcon A/Etafilcon A/Senofilcon A
First Intervention: alphafilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: senofilcon A toric contact lenses
Etafilcon A/Senofilcon A/Alphafilcon A
First Intervention: etafilcon A sphere contact lenses Second Intervention: senofilcon A toric contact lenses Third Intervention: alphafilcon A toric contact lenses
Senofilcon A/Etafilcon A/Alphafilcon A
First Intervention: senofilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: alphafilcon A toric contact lenses
Alphafilcon A/Senofilcon A/Etafilcon A
First intervention: alphafilcon A toric Second intervention: senofilcon A toric Third intervention: etafilcon A sphere
Etafilcon A/Alphafilcon A/Senofilcon A
First intervention: etafilcon A sphere contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: senofilcon A toric contact lenses
First Intervention
Discontinuation
0
0
1
0
0
0
Third Intervention
Protocol Violation
0
0
1
0
4
2

Baseline Characteristics

In-office Evaluation of Two Toric Soft Contact Lenses and a Spherical Soft Contact Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Completed Population
n=88 Participants
Only participants that completed the study are included (n=88)
Age, Continuous
28.0 years
STANDARD_DEVIATION 5.96 • n=5 Participants
Sex: Female, Male
Female
52 Participants
n=5 Participants
Sex: Female, Male
Male
36 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 15-20 minutes

Population: Analysis includes participants who completed the study per protocol (n=88 subjects,176 eyes)

Number of eyes with Distance Visual Acuity 20/20 or better

Outcome measures

Outcome measures
Measure
Senofilcon A Toric
n=88 Participants
Alphafilcon A Toric
n=88 Participants
Etafilcon A Sphere
n=88 Participants
Visual Acuity
146 Eyes with Snellen VA 20/20 or better
136 Eyes with Snellen VA 20/20 or better
37 Eyes with Snellen VA 20/20 or better

PRIMARY outcome

Timeframe: 15-20 minutes

Population: Analysis includes participants who completed the study per protocol (n=88)

A weighted combined score calculated from individual confort-vision related questions asked on a 1-5 scale, 1=most negative resonse to 5=most positive response, was used to derive vision scores. The analysis shows the difference in outcome between test and control. \>0=greater vision, \<0=lesser vision.

Outcome measures

Outcome measures
Measure
Senofilcon A Toric
n=88 Participants
Alphafilcon A Toric
n=88 Participants
Etafilcon A Sphere
n=88 Participants
Patient Reported Vision
0.2845 Scores on a scale
Standard Error 0.098
0.1332 Scores on a scale
Standard Error 0.098
-0.4310 Scores on a scale
Standard Error 0.097

PRIMARY outcome

Timeframe: 1 minute

Population: Analysis includes participants who completed the study per protocol (n=88 subjects, 176 eyes)

Meaures in what position does the lens sit on the eye at insertion and is measured in degrees of rotation.

Outcome measures

Outcome measures
Measure
Senofilcon A Toric
n=88 Participants
Alphafilcon A Toric
n=88 Participants
Etafilcon A Sphere
Lens Orientation Within 5 Degrees
142 degrees
126 degrees
—

PRIMARY outcome

Timeframe: 1 minute

Population: Analysis includes participants who completed the study per protocol (n=88 subjects, 176 eyes)

Measures if the lens changes position on the eye as it is worn and is measured in degrees of rotation.

Outcome measures

Outcome measures
Measure
Senofilcon A Toric
n=88 Participants
Alphafilcon A Toric
n=88 Participants
Etafilcon A Sphere
Lens Stability Within 5 Degrees
156 degrees
140 degrees
—

PRIMARY outcome

Timeframe: 15-20 minutes

Population: Analysis includes participants who completed the study per protocol (n=88)

A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale, 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. \>0=comfortable, \<0=uncomfortable

Outcome measures

Outcome measures
Measure
Senofilcon A Toric
n=88 Participants
Alphafilcon A Toric
n=88 Participants
Etafilcon A Sphere
n=88 Participants
Patient Reported Comfort.
0.1425 Scores on a scale
Standard Error 0.1034
-0.3464 Scores on a scale
Standard Error 0.1035
0.2176 Scores on a scale
Standard Error 0.1028

PRIMARY outcome

Timeframe: end of study

Population: Analysis includes participants who completed the study per protocol (n=88)

This outcome measures which lens the subjects preferred to wear.

Outcome measures

Outcome measures
Measure
Senofilcon A Toric
n=88 Participants
Alphafilcon A Toric
n=88 Participants
Etafilcon A Sphere
n=88 Participants
Patient Preference
62 Number of participants
5 Number of participants
18 Number of participants

Adverse Events

Senofilcon A/Alphafilcon A/Etafilcon A

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

Alphafilcon A/Etafilcon A/Senofilcon A

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

Etafilcon A/Senofilcon A/Alphafilcon A

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

Senofilcon A/Etafilcon A/Alphafilcon A

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

Alphafilcon A/Senofilcon A/Etafilcon A

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

Etafilcon A/Alphafilcon A/Senofilcon 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

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