Trial Outcomes & Findings for The Clinical Evaluation of Two Daily Disposable Contact Lenses (NCT NCT00762996)

NCT ID: NCT00762996

Last Updated: 2018-06-19

Results Overview

logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 65 participants
• Primary outcome timeframe: 1 week
• Results posted on: 2018-06-19

Participant Flow

Participant milestones

Measure	Etafilcon A / Etafilcon A Period 1: etafilcon A, Period 2: etafilcon A	Etafilcon A / Omafilcon A Period 1: etafilcon A, Period 2: omafilcon A	Omafilcon A / Etafilcon A Period 1: omafilcon A, Period 2: etafilcon A	Omafilcon A / Omafilcon A Period 1: omafilcon A, Period 2: omafilcon A
Period One STARTED	15	16	17	17
Period One COMPLETED	15	16	13	16
Period One NOT COMPLETED	0	0	4	1
Period Two STARTED	15	16	13	16
Period Two COMPLETED	15	16	13	16
Period Two NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Measure	Etafilcon A / Etafilcon A Period 1: etafilcon A, Period 2: etafilcon A	Etafilcon A / Omafilcon A Period 1: etafilcon A, Period 2: omafilcon A	Omafilcon A / Etafilcon A Period 1: omafilcon A, Period 2: etafilcon A	Omafilcon A / Omafilcon A Period 1: omafilcon A, Period 2: omafilcon A
Period One Protocol Violation	0	0	1	0
Period One ineligible	0	0	1	1
Period One Adverse Event	0	0	1	0
Period One Withdrawal by Subject	0	0	1	0

Baseline Characteristics

The Clinical Evaluation of Two Daily Disposable Contact Lenses

Baseline characteristics by cohort

Measure	Entire Population n=65 Participants
Age, Continuous	28.9 years STANDARD_DEVIATION 5.3 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.

Outcome measures

Measure	Etafilcon A n=44 Participants	Omafilcon A n=45 Participants
Distance Visual Acuity	0.03460 logMar Standard Error 0.007129	0.02931 logMar Standard Error 0.006666

SECONDARY outcome

Timeframe: 1 week

A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control.>0 = comfortable, <0 = uncomfortable

Outcome measures

Measure	Etafilcon A n=15 Participants	Omafilcon A n=16 Participants
Lens Comfort	0.3113 Units on a scale Standard Error 0.1765	-0.1645 Units on a scale Standard Error 0.2075

Adverse Events

Etafilcon A / Etafilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Etafilcon A / Omafilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Omafilcon A / Etafilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Omafilcon A / Omafilcon 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, FAAO

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