Trial Outcomes & Findings for A Clinical Comparison of Two Soft Contact Lenses (NCT NCT05741450)

Results Overview

Subjective overall score was assessed using 0-100 visual analogue scale, where 0=Extremely poor, cannot use lenses and 100=Excellent, highly impressed with these lenses overall

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

15 minutes

Results posted on

2024-01-10

Participant Flow

Participant milestones

Participant milestones
Measure	Lens 1 (Monthly Replacement) All participants wore Lens 1 for 15 minutes (Period 1)	Lens 2 (Daily Disposable) All participants wore Lens 2 for 15 minutes (Period 2)
Period 1: Lens 1, 15 Minutes STARTED	45	0
Period 1: Lens 1, 15 Minutes COMPLETED	45	0
Period 1: Lens 1, 15 Minutes NOT COMPLETED	0	0
Period 2: Lens 2, 15 Minutes STARTED	0	45
Period 2: Lens 2, 15 Minutes COMPLETED	0	45
Period 2: Lens 2, 15 Minutes NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age data is presented as stratified by the sex of the participant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=45 Participants All participants who participated in the clinical trial.
Age, Continuous Female	32.4 years STANDARD_DEVIATION 11.9 • n=28 Participants • Age data is presented as stratified by the sex of the participant
Age, Continuous Male	37.3 years STANDARD_DEVIATION 15.0 • n=17 Participants • Age data is presented as stratified by the sex of the participant
Sex: Female, Male Female	28 Participants n=45 Participants
Sex: Female, Male Male	17 Participants n=45 Participants

PRIMARY outcome

Timeframe: 15 minutes

Population: One participant was excluded from data analysis due to issues during lens application

Subjective overall score was assessed using 0-100 visual analogue scale, where 0=Extremely poor, cannot use lenses and 100=Excellent, highly impressed with these lenses overall

Outcome measures

Outcome measures
Measure	Lens 1 n=44 Participants All participants that received Lens 1	Lens 2 n=44 Participants All participants that received Lens 2
Subjective Overall Score	84.7 score on a scale Standard Deviation 15.5	82.5 score on a scale Standard Deviation 14.6

SECONDARY outcome

Timeframe: 15 minutes

Population: One participant was excluded from data analysis due to issues during lens application

Subjective comfort score was assessed using 0-100 visual analogue scale, where 0=Causes pain, cannot be tolerated and 100=Excellent, cannot be felt

Outcome measures

Outcome measures
Measure	Lens 1 n=44 Participants All participants that received Lens 1	Lens 2 n=44 Participants All participants that received Lens 2
Subjective Comfort	86.4 score on a scale Standard Deviation 16.4	86.6 score on a scale Standard Deviation 13.5

SECONDARY outcome

Timeframe: 15 minutes

Population: One participant was excluded from data analysis due to issues during lens application

Subjective vision score was assessed using a 0-100 visual analogue scale, where 0=Unacceptable, lens cannot be worn and 100=Excellent, unaware of any visual loss

Outcome measures

Outcome measures
Measure	Lens 1 n=44 Participants All participants that received Lens 1	Lens 2 n=44 Participants All participants that received Lens 2
Subjective Vision	85.8 score on a scale Standard Deviation 14.9	82.7 score on a scale Standard Deviation 15.9

Adverse Events

Lens 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lens 2

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

José A. Vega OD, MSc, FAAO

CooperVision, Inc.

Phone: +19256213761

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place