Trial Outcomes & Findings for Clinical Comparison of Two Daily Disposable Toric Lenses (NCT NCT01362894)

NCT ID: NCT01362894

Last Updated: 2012-08-09

Results Overview

As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 240 participants
• Primary outcome timeframe: 1 week, replacing lenses daily
• Results posted on: 2012-08-09

Participant Flow

Participants were recruited and enrolled from 19 German study sites.

Two participants were enrolled, but not dispensed, due to unacceptable objective vision (1) and biomicroscopy findings (1). Baseline characteristics are presented on all enrolled and dispensed participants: 238.

Participant milestones

Measure	Nelfilcon A / Etafilcon A Nelfilcon A lenses worn first, with etafilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.	Etafilcon A / Nelfilcon A Etafilcon A lenses worn first, with nelfilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Period One, 1 Week STARTED	119	117
Period One, 1 Week COMPLETED	119	117
Period One, 1 Week NOT COMPLETED	0	0
Period Two, 1 Week STARTED	118	115
Period Two, 1 Week COMPLETED	118	115
Period Two, 1 Week NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Comparison of Two Daily Disposable Toric Lenses

Baseline characteristics by cohort

Measure	Overall n=238 Participants All enrolled and dispensed participants.
Age Continuous	31.4 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	159 Participants n=5 Participants
Sex: Female, Male Male	79 Participants n=5 Participants
Region of Enrollment Germany	238 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week, replacing lenses daily

Population: The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.

As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Measure	Nelfilcon A n=226 Participants Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.	Etafilcon A n=228 Participants Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Overall Vision	8.2 Units on a scale Standard Deviation 1.7	7.5 Units on a scale Standard Deviation 2.1

PRIMARY outcome

Timeframe: 1 week, replacing lenses daily

Population: The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.

As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was rated on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Measure	Nelfilcon A n=227 Participants Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.	Etafilcon A n=229 Participants Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Overall Comfort	7.8 Units on a scale Standard Deviation 1.8	7.2 Units on a scale Standard Deviation 2.0

PRIMARY outcome

Timeframe: 1 week, replacing lenses daily

Population: The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.

As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was rated on a 10-point scale, with 1 being difficult and 10 being easy.

Outcome measures

Measure	Nelfilcon A n=227 Participants Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.	Etafilcon A n=229 Participants Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Overall Handling	8.2 Units on a scale Standard Deviation 1.8	6.8 Units on a scale Standard Deviation 2.2

PRIMARY outcome

Timeframe: 1 week, replacing lenses daily

Population: The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.

As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Measure	Nelfilcon A n=227 Participants Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.	Etafilcon A n=229 Participants Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Overall Satisfaction	7.7 Units on a scale Standard Deviation 1.9	6.9 Units on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: Day 0

Population: The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.

As interpreted by the investigator at time of lens fitting and recorded on a questionnaire. Ease of selecting final lens power was rated on a 10-point scale, with 1 being difficult and 10 being easy.

Outcome measures

Measure	Nelfilcon A n=228 Participants Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.	Etafilcon A n=229 Participants Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Ease of Selecting Final Lens Power	8.4 Units on a scale Standard Deviation 1.5	8.8 Units on a scale Standard Deviation 1.2

Adverse Events

Nelfilcon A

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Etafilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Nelfilcon A n=234 participants at risk Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.	Etafilcon A n=235 participants at risk Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Surgical and medical procedures Appendicitis	0.43% 1/234 • Number of events 1 • Adverse events were collected for the duration of the study: 20-May-2011 to 15-AUG-2011. The safety population included all enrolled and dispensed participants.	0.00% 0/235 • Adverse events were collected for the duration of the study: 20-May-2011 to 15-AUG-2011. The safety population included all enrolled and dispensed participants.
Musculoskeletal and connective tissue disorders Foot injury requiring hospitalization	0.43% 1/234 • Number of events 1 • Adverse events were collected for the duration of the study: 20-May-2011 to 15-AUG-2011. The safety population included all enrolled and dispensed participants.	0.00% 0/235 • Adverse events were collected for the duration of the study: 20-May-2011 to 15-AUG-2011. The safety population included all enrolled and dispensed participants.

Other adverse events

Adverse event data not reported

Additional Information

Stacie Cummings, O.D.

Alcon Research, Ltd.

Phone: 1-800-241-7629

Results disclosure agreements

• Principal investigator is a sponsor employee For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.
• Publication restrictions are in place

Restriction type: OTHER