Trial Outcomes & Findings for Clinical Study of Approved Contact Lenses (NCT NCT03351101)

Last Updated: 2021-01-08

Results Overview

The 100 point , take home questionnaire evaluated performance of the lenses based on subject responses. Possible scores were 0-100. Higher scores indicated greater comfort.

Recruitment status

COMPLETED

Study phase

Target enrollment

271 participants

Primary outcome timeframe

1 month

Results posted on

2021-01-08

Participant Flow

There were 271 participants enrolled, with 136 Senofilcon C participants dispensed lenses and 132 Samfilcon A participants dispensed lenses (268 participants total).

Participant milestones

Participant milestones
Measure	Senofilcon C Senofilcon C Contact Lens Senofilcon C: Senofilcon C Contact Lens	Samfilcon A Samfilcon A Contact Lens Samfilcon A: Samfilcon A Contact Lens
Overall Study STARTED	136	132
Overall Study COMPLETED	135	129
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Study of Approved Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Senofilcon C n=115 Participants Senofilcon C Contact Lens Senofilcon C: Senofilcon C Contact Lens	Samfilcon A n=106 Participants Samfilcon A Contact Lens Samfilcon A: Samfilcon A Contact Lens	Total n=221 Participants Total of all reporting groups
Age, Continuous	30.5 years STANDARD_DEVIATION 5.62 • n=5 Participants	30.4 years STANDARD_DEVIATION 5.72 • n=7 Participants	30.45 years STANDARD_DEVIATION 5.58 • n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants	68 Participants n=7 Participants	139 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants	38 Participants n=7 Participants	82 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	98 Participants n=5 Participants	90 Participants n=7 Participants	188 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Population: All participants that completed all study visits without a major protocol deviation.

The 100 point , take home questionnaire evaluated performance of the lenses based on subject responses. Possible scores were 0-100. Higher scores indicated greater comfort.

Outcome measures

Outcome measures
Measure	Senofilcon C n=115 Participants Senofilcon C Contact Lens Senofilcon C: Senofilcon C Contact Lens	Samfilcon A n=106 Participants Samfilcon A Contact Lens Samfilcon A: Samfilcon A Contact Lens
End of Day Comfort	80 score on a scale Standard Deviation 18.15	80 score on a scale Standard Deviation 20.46

PRIMARY outcome

Timeframe: 1 month

Population: All participants that completed all study visits without a major protocol deviation.

The 100 point , take home questionnaire evaluated performance of the lenses based on subject responses. Possible scores were 0-100. Higher scores indicated better overall vision.

Outcome measures

Outcome measures
Measure	Senofilcon C n=115 Participants Senofilcon C Contact Lens Senofilcon C: Senofilcon C Contact Lens	Samfilcon A n=106 Participants Samfilcon A Contact Lens Samfilcon A: Samfilcon A Contact Lens
Overall Vision	95 score on a scale Standard Deviation 9.68	95 score on a scale Standard Deviation 12.15

Adverse Events

Senofilcon C

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Samfilcon A

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Senofilcon C n=136 participants at risk Senofilcon C Contact Lens Senofilcon C: Senofilcon C Contact Lens	Samfilcon A n=132 participants at risk Samfilcon A Contact Lens Samfilcon A: Samfilcon A Contact Lens
Eye disorders Corneal infiltrates	0.00% 0/136 • 1 month	0.76% 1/132 • 1 month

Additional Information

Study Director

Bausch Health

Phone: +1 (585) 338-6399

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Contact sponsor directly for details.
Publication restrictions are in place

Restriction type: OTHER