Trial Outcomes & Findings for A Comparison of Two Daily Disposable Contact Lenses. (NCT NCT00721500)

Last Updated: 2015-05-21

Results Overview

Overall lens fit acceptance was assessed by the Investigator based on lens fit alone in a 6-level scale; 0=should not be worn, 1=should not be dispensed although no immediate danger, 2=borderline but unacceptable, 3=minimal acceptable, early review, 4=not perfect but OK to dispense and 5=perfect. Lens fitting responses \>2 were considered 'successful fit' while the rest of responses were considered 'unsuccessful fit'.

Recruitment status

COMPLETED

Study phase

Target enrollment

25 participants

Primary outcome timeframe

Within 20 minutes of lens insertion

Results posted on

2015-05-21

Participant Flow

There were 25 subjects enrolled to the study.

Subjects were enrolled per inclusion/exclusion criteria and randomized to a study arm.

Participant milestones

Participant milestones
Measure	Narafilcon A/Etafilcon A - Etafilcon A - Narafilcon A First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A contact lenses worn in both eyes.	Narafilcon A/Etafilcon A - Narafilcon A - Etafilcon A First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, narafilcon A contact lenses worn in both eyes. Third, etafilcon A contact lenses worn in both eyes.	Narafilcon A - Etafilcon A - Narafilcon A/Etafilcon A First, narafilcon A contact lenses worn in both eyes. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.	Etafilcon A - Narafilcon A - Narafilcon A/Etafilcon A First, etafilcon A contact lenses worn in both eyes. Second, narafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.
Period One STARTED	6	7	6	6
Period One COMPLETED	6	7	6	6
Period One NOT COMPLETED	0	0	0	0
Period Two STARTED	6	7	6	6
Period Two COMPLETED	6	7	6	6
Period Two NOT COMPLETED	0	0	0	0
Period Three STARTED	6	7	6	6
Period Three COMPLETED	6	7	6	6
Period Three NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comparison of Two Daily Disposable Contact Lenses.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=25 Participants All subjects who enrolled and completed study.
Age, Continuous	44.9 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United Kingdom	25 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 20 minutes of lens insertion

Population: Participants who were enrolled and completed the study.

Outcome measures

Outcome measures
Measure	Narafilcon A (Bilateral) n=50 eyes narafilcon A contact lens worn in both eyes.	Narafilcon A (Contralateral) n=25 eyes Narafilcon A worn in either eye.	Etafilcon A (Bilateral) n=50 eyes Etafilcon A contact lens worn in both eyes.	Etafilcon A (Contralateral) n=25 eyes Etafilcon A worn in either eye.
Proportion of Eyes Successfully Fit	0.98 proportion of participant eyes	0.96 proportion of participant eyes	0.96 proportion of participant eyes	0.96 proportion of participant eyes

PRIMARY outcome

Timeframe: Within 20 minutes of lens insertion

Population: Participants who were enrolled and completed the study.

Lens centration was assessed in primary gaze, diffuse white light, low-medium magnification, with graticule. Lens fit decentration with respect to visible cornea was measured to nearest 0.1mm.

Outcome measures

Outcome measures
Measure	Narafilcon A (Bilateral) n=50 eye narafilcon A contact lens worn in both eyes.	Narafilcon A (Contralateral) n=25 eye Narafilcon A worn in either eye.	Etafilcon A (Bilateral) n=50 eye Etafilcon A contact lens worn in both eyes.	Etafilcon A (Contralateral) n=25 eye Etafilcon A worn in either eye.
Lens Fit Decentration	0.25 mm Standard Deviation 0.14	0.22 mm Standard Deviation 0.16	0.27 mm Standard Deviation 0.17	0.27 mm Standard Deviation 0.15

PRIMARY outcome

Timeframe: Within 20 minutes of lens insertion

Population: Participants who were enrolled and completed the study.

Lens tightness on push-up assessed by digital push-up test (gentle push of the lens upward using the lower lid) with eye in primary gaze position and observing ease of push-up and speed of return to original position. Tightness is measured on a 0%-100% continuous scale where 0%=falls from cornea without lid support, 50%=optimum and 100%=no movement.

Outcome measures

Outcome measures
Measure	Narafilcon A (Bilateral) n=50 eye narafilcon A contact lens worn in both eyes.	Narafilcon A (Contralateral) n=25 eye Narafilcon A worn in either eye.	Etafilcon A (Bilateral) n=50 eye Etafilcon A contact lens worn in both eyes.	Etafilcon A (Contralateral) n=25 eye Etafilcon A worn in either eye.
Lens Tightness on Cornea With Manual Digit Push Up	44.6 percentage Standard Deviation 6.3	46.9 percentage Standard Deviation 5.5	56.3 percentage Standard Deviation 8.6	58.1 percentage Standard Deviation 7.8

Adverse Events

Narafilcon A/Etafilcon A - Etafilcon A - Narafilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Narafilcon A/Etafilcon A - Narafilcon A - Etafilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Narafilcon A - Etafilcon A - Narafilcon A/Etafilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Etafilcon A - Narafilcon A - Narafilcon A/Etafilcon 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 FAOO / Director

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