Trial Outcomes & Findings for Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Lens Wearers (NCT NCT00953407)

Results Overview

Lens awareness, as interpreted by the subject, was reported by the subject as a single, retrospective evaluation of 4 week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being all the time. Four-week ratings were compared to baseline ratings, and a negative difference (4-week minus baseline) represented an improvement.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

128 participants

Primary outcome timeframe

4 weeks of wear

Results posted on

2012-07-10

Participant Flow

Two participants were enrolled but not dispensed due to failing inclusion/exclusion criteria. These participants were included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.

Participant milestones

Participant milestones
Measure	Nelfilcon A Nelfilcon A contact lens	Narafilcon A Narafilcon A contact lens	Etafilcon A Etafilcon A contact lens	Omafilcon A Omafilcon A contact lens	Hilafilcon B Hilafilcon B contact lens
Overall Study STARTED	26	25	26	25	24
Overall Study COMPLETED	25	24	25	23	23
Overall Study NOT COMPLETED	1	1	1	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Nelfilcon A Nelfilcon A contact lens	Narafilcon A Narafilcon A contact lens	Etafilcon A Etafilcon A contact lens	Omafilcon A Omafilcon A contact lens	Hilafilcon B Hilafilcon B contact lens
Overall Study Failed inclusion criteria	1	1	1	1	1
Overall Study Lost to Follow-up	0	0	0	1	0

Baseline Characteristics

Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Lens Wearers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nelfilcon A n=26 Participants Nelfilcon A spherical contact lens worn on a daily wear, daily disposable basis	Narafilcon A n=25 Participants Narafilcon A spherical contact lens worn on a daily wear, daily disposable basis	Etafilcon A n=26 Participants Etafilcon A spherical contact lens worn on a daily wear, daily disposable basis	Omafilcon A n=25 Participants Omafilcon A spherical contact lens worn on a daily wear, daily disposable basis	Hilafilcon B n=24 Participants Hilafilcon B spherical contact lens worn on a daily wear, daily disposable basis	Total n=126 Participants Total of all reporting groups
Age Continuous	29.5 years STANDARD_DEVIATION 7.0 • n=93 Participants	31.5 years STANDARD_DEVIATION 11.9 • n=4 Participants	29.9 years STANDARD_DEVIATION 10.1 • n=27 Participants	28.3 years STANDARD_DEVIATION 7.7 • n=483 Participants	30.5 years STANDARD_DEVIATION 9.6 • n=36 Participants	29.9 years STANDARD_DEVIATION 9.3 • n=10 Participants
Sex: Female, Male Female	18 Participants n=93 Participants	15 Participants n=4 Participants	20 Participants n=27 Participants	19 Participants n=483 Participants	17 Participants n=36 Participants	89 Participants n=10 Participants
Sex: Female, Male Male	8 Participants n=93 Participants	10 Participants n=4 Participants	6 Participants n=27 Participants	6 Participants n=483 Participants	7 Participants n=36 Participants	37 Participants n=10 Participants

PRIMARY outcome

Timeframe: 4 weeks of wear

Population: Per protocol. Analysis excluded major protocol deviations as determined by masked review.

Lens awareness, as interpreted by the subject, was reported by the subject as a single, retrospective evaluation of 4 week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being all the time. Four-week ratings were compared to baseline ratings, and a negative difference (4-week minus baseline) represented an improvement.