Trial Outcomes & Findings for Clinical Performance Comparison of Several Different Contact Lenses (NCT NCT00912028)

Results Overview

Subject distribution according to limbal hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

71 participants

Primary outcome timeframe

2 weeks

Results posted on

2018-06-19

Participant Flow

Participant milestones

Participant milestones
Measure	Senofilcon A contact lens senofilcon A: contact lens	Lotrafilcon B contact lens lotrafilcon B: contact lens	Balafilcon A contact lens balafilcon A: contact lens	Methafilcon A contact lens methafilcon A: contact lens	Vifilcon A contact lens vifilcon A: contact lens
Overall Study STARTED	35	3	13	17	3
Overall Study COMPLETED	30	0	13	16	0
Overall Study NOT COMPLETED	5	3	0	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Senofilcon A contact lens senofilcon A: contact lens	Lotrafilcon B contact lens lotrafilcon B: contact lens	Balafilcon A contact lens balafilcon A: contact lens	Methafilcon A contact lens methafilcon A: contact lens	Vifilcon A contact lens vifilcon A: contact lens
Overall Study Lost to Follow-up	2	3	0	1	3
Overall Study Withdrawal by Subject	3	0	0	0	0

Baseline Characteristics

Clinical Performance Comparison of Several Different Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Senofilcon A n=30 Participants contact lens senofilcon A: contact lens	Balafilcon A n=13 Participants contact lens balafilcon A: contact lens	Methafilcon A n=16 Participants contact lens methafilcon A: contact lens	Total n=59 Participants Total of all reporting groups
Age, Continuous	23.9 years STANDARD_DEVIATION 3.9 • n=93 Participants	22.7 years STANDARD_DEVIATION 3.5 • n=4 Participants	27.0 years STANDARD_DEVIATION 4.2 • n=27 Participants	24.5 years STANDARD_DEVIATION 4.2 • n=483 Participants
Sex: Female, Male Female	26 Participants n=93 Participants	7 Participants n=4 Participants	13 Participants n=27 Participants	46 Participants n=483 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	6 Participants n=4 Participants	3 Participants n=27 Participants	13 Participants n=483 Participants
Region of Enrollment Brazil	30 participants n=93 Participants	13 participants n=4 Participants	16 participants n=27 Participants	59 participants n=483 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: Analysis is on those subjects who were enrolled, randomized, and completed the study.

Subject distribution according to limbal hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.

Outcome measures

Outcome measures
Measure	Senofilcon A n=60 eyes contact lens senofilcon A: contact lens	Balafilcon A n=26 eyes contact lens balafilcon A: contact lens	Methafilcon A n=32 eyes contact lens methafilcon A: contact lens
Limbal Hyperemia (Redness) Grade 0	40 eyes	14 eyes	24 eyes
Limbal Hyperemia (Redness) Grade 1	12 eyes	4 eyes	4 eyes
Limbal Hyperemia (Redness) Grade 2	8 eyes	8 eyes	4 eyes
Limbal Hyperemia (Redness) Grade 3	0 eyes	0 eyes	0 eyes
Limbal Hyperemia (Redness) Grade 4	0 eyes	0 eyes	0 eyes

PRIMARY outcome

Timeframe: 4 weeks

Population: Analysis is on those subjects who are enrolled, randomized to a study arm, and who completed the study.

Subject distribution according to limbal hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.

Outcome measures

Outcome measures
Measure	Senofilcon A n=60 eyes contact lens senofilcon A: contact lens	Balafilcon A n=26 eyes contact lens balafilcon A: contact lens	Methafilcon A n=32 eyes contact lens methafilcon A: contact lens
Limbal Hyperemia (Redness) Grade 0	46 eyes	16 eyes	18 eyes
Limbal Hyperemia (Redness) Grade 1	10 eyes	4 eyes	12 eyes
Limbal Hyperemia (Redness) Grade 2	6 eyes	4 eyes	2 eyes
Limbal Hyperemia (Redness) Grade 3	0 eyes	0 eyes	0 eyes
Limbal Hyperemia (Redness) Grade 4	0 eyes	0 eyes	0 eyes

PRIMARY outcome

Timeframe: 2 weeks

Subject distribution according to bulbar hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.

Outcome measures

Outcome measures
Measure	Senofilcon A n=60 eyes contact lens senofilcon A: contact lens	Balafilcon A n=26 eyes contact lens balafilcon A: contact lens	Methafilcon A n=32 eyes contact lens methafilcon A: contact lens
Bulbar Hyperemia (Redness) Grade 0	43 eyes	12 eyes	20 eyes
Bulbar Hyperemia (Redness) Grade 1	12 eyes	12 eyes	8 eyes
Bulbar Hyperemia (Redness) Grade 2	5 eyes	2 eyes	4 eyes
Bulbar Hyperemia (Redness) Grade 3	0 eyes	0 eyes	0 eyes
Bulbar Hyperemia (Redness) Grade 4	0 eyes	0 eyes	0 eyes

PRIMARY outcome

Timeframe: 4 weeks

Population: Analysis is on those who are enrolled, randomized to a study arm, and completed the study.

Subject distribution according to bulbar hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.

Outcome measures

Outcome measures
Measure	Senofilcon A n=60 eyes contact lens senofilcon A: contact lens	Balafilcon A n=26 eyes contact lens balafilcon A: contact lens	Methafilcon A n=32 eyes contact lens methafilcon A: contact lens
Bulbar Hyperemia (Redness) Grade 0	45 eyes	11 eyes	23 eyes
Bulbar Hyperemia (Redness) Grade 1	12 eyes	13 eyes	9 eyes
Bulbar Hyperemia (Redness) Grade 2	3 eyes	0 eyes	0 eyes
Bulbar Hyperemia (Redness) Grade 3	0 eyes	0 eyes	0 eyes
Bulbar Hyperemia (Redness) Grade 4	0 eyes	0 eyes	0 eyes

PRIMARY outcome

Timeframe: 2 weeks

Population: Analysis was on those subjects who were enrolled, randomized to a study arm, and completed the study.

Subject distribution according to corneal staining with fluorescein scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.

Outcome measures

Outcome measures
Measure	Senofilcon A n=60 eyes contact lens senofilcon A: contact lens	Balafilcon A n=26 eyes contact lens balafilcon A: contact lens	Methafilcon A n=32 eyes contact lens methafilcon A: contact lens
Corneal Staining Grade 0	27 eyes	8 eyes	10 eyes
Corneal Staining Grade 1	27 eyes	16 eyes	19 eyes
Corneal Staining Grade 2	6 eyes	2 eyes	3 eyes
Corneal Staining Grade 3	0 eyes	0 eyes	0 eyes
Corneal Staining Grade 4	0 eyes	0 eyes	0 eyes

PRIMARY outcome

Timeframe: 4 weeks

Population: Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.

Subject distribution according to corneal staining with fluorescein scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.