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Trial Outcomes & Findings for Clinical Performance Comparison of Two Contact Lenses (NCT NCT00975585)

NCT ID: NCT00975585

Last Updated: 2018-06-19

Results Overview

The overall score is the average of the total scores of each of five regions of the cornea. The minimum average score is 0 and the maximum average score is 3. Corneal surface abnormality as indicated by the severity of staining over five regions of the cornea (central, superior, inferior, nasal and temporal) was assessed by the investigator using the following scale: 0=none, 1=slight, 2=moderate, 3=severe.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

379 participants

Primary outcome timeframe

2 weeks

Results posted on

2018-06-19

Participant Flow

Participant milestones

Participant milestones
Measure
Senofilcon A
contact lens
Lotrafilcon B
contact lens
Overall Study
STARTED
184
195
Overall Study
COMPLETED
177
183
Overall Study
NOT COMPLETED
7
12

Reasons for withdrawal

Reasons for withdrawal
Measure
Senofilcon A
contact lens
Lotrafilcon B
contact lens
Overall Study
Adverse Event
0
4
Overall Study
Lost to Follow-up
3
5
Overall Study
Withdrawal by Subject
2
1
Overall Study
Lens issue
2
2

Baseline Characteristics

Clinical Performance Comparison of Two Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Senofilcon A
n=184 Participants
contact lens
Lotrafilcon B
n=195 Participants
contact lens
Total
n=379 Participants
Total of all reporting groups
Age, Continuous
29.7 years
STANDARD_DEVIATION 7.0 • n=5 Participants
29.3 years
STANDARD_DEVIATION 6.9 • n=7 Participants
29.5 years
STANDARD_DEVIATION 6.9 • n=5 Participants
Sex: Female, Male
Female
125 Participants
n=5 Participants
136 Participants
n=7 Participants
261 Participants
n=5 Participants
Sex: Female, Male
Male
59 Participants
n=5 Participants
59 Participants
n=7 Participants
118 Participants
n=5 Participants
Region of Enrollment
United States
184 participants
n=5 Participants
195 participants
n=7 Participants
379 participants
n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: Analysis included all subjects that completed the study.

The overall score is the average of the total scores of each of five regions of the cornea. The minimum average score is 0 and the maximum average score is 3. Corneal surface abnormality as indicated by the severity of staining over five regions of the cornea (central, superior, inferior, nasal and temporal) was assessed by the investigator using the following scale: 0=none, 1=slight, 2=moderate, 3=severe.

Outcome measures

Outcome measures
Measure
Senofilcon A
n=177 Participants
contact lens
Lotrafilcon B
n=183 Participants
contact lens
Average Corneal Staining
0.157 units on a scale
Standard Error 0.018
0.170 units on a scale
Standard Error 0.018

PRIMARY outcome

Timeframe: 2 weeks

Visual acuity was assessed by the investigator using the Snellen chart and converted to the logarithm of the minimum angle of resolution (logMAR). logMAR ideal is 0.0 and represents 20/20 Snellen visual acuity. logMAR values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.

Outcome measures

Outcome measures
Measure
Senofilcon A
n=177 Participants
contact lens
Lotrafilcon B
n=183 Participants
contact lens
Visual Acuity
-0.012 logMAR units
Standard Error 0.003
-0.002 logMAR units
Standard Error 0.003

PRIMARY outcome

Timeframe: 2 weeks

Population: Analysis includes subjects that completed the study.

After two weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (senofilcon A and lotrafilcon B) using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.

Outcome measures

Outcome measures
Measure
Senofilcon A
n=177 Participants
contact lens
Lotrafilcon B
n=183 Participants
contact lens
Overall Comfort
3.938 units on a scale
Standard Error 0.090
3.536 units on a scale
Standard Error 0.091

PRIMARY outcome

Timeframe: 2 weeks and 4 weeks

Population: Analysis includes all subjects that completed the study.

After four weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (lotrafilcon B)using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.

Outcome measures

Outcome measures
Measure
Senofilcon A
n=183 Participants
contact lens
Lotrafilcon B
n=183 Participants
contact lens
Overall Comfort
3.534 units on a scale
Standard Error 0.111
3.436 units on a scale
Standard Error 0.118

SECONDARY outcome

Timeframe: 2 weeks

Population: Analysis includes subjects that completed the study.

The investigator assessed limbal redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe

Outcome measures

Outcome measures
Measure
Senofilcon A
n=177 Participants
contact lens
Lotrafilcon B
n=183 Participants
contact lens
Limbal Redness
0.376 units on a scale
Standard Error 0.031
0.499 units on a scale
Standard Error 0.030

SECONDARY outcome

Timeframe: 2 weeks

Population: Analysis includes subjects that completed the study.

The investigator assessed bulbar redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe

Outcome measures

Outcome measures
Measure
Senofilcon A
n=177 Participants
contact lens
Lotrafilcon B
n=183 Participants
contact lens
Bulbar Redness
0.465 units on a scale
Standard Error 0.031
0.532 units on a scale
Standard Error 0.030

SECONDARY outcome

Timeframe: 2 weeks

Population: Analysis includes subjects that completed the study.

Subjects responded to a phone survey question regarding the frequency of the sensation of dryness while wearing the study contact lenses using the following scale: 1=Extreme, 2=Moderate, 3=Slight, 4=None

Outcome measures

Outcome measures
Measure
Senofilcon A
n=177 Participants
contact lens
Lotrafilcon B
n=183 Participants
contact lens
Symptoms of Dryness
2.003 units on a scale
Standard Error 0.087
2.414 units on a scale
Standard Error 0.088

Adverse Events

Senofilcon A

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

Lotrafilcon B

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

Sheila Hickson-Curran, MCOptom/ Director, Medical Affairs

Vistakon

Phone: 904-443-1754

Results disclosure agreements

  • Principal investigator is a sponsor employee Prior to submission for publication or presentation, the PI will provide SPONSOR with at least sixty (60) days for review of a manuscript. Notwithstanding the foregoing, no paper that incorporates SPONSOR Confidential Information will be submitted for publication without SPONSOR's prior written consent. If requested in writing, the PI will withhold such publication for up to an additional sixty (60) days to allow for filing of a patent application.
  • Publication restrictions are in place

Restriction type: OTHER