Trial Outcomes & Findings for A Clinical Comparison of Two Soft Multifocal Contact Lenses (NCT NCT05794126)

Results Overview

Subjective Overall Score was assessed using the 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

47 participants

Primary outcome timeframe

15 Minutes

Results posted on

2024-04-10

Participant Flow

Participant milestones

Participant milestones
Measure	Lens 1 All participants wore Lens 1 for 15 minutes (Period 1)	Lens 2 All participants wore Lens 2 for 15 minutes (Period 2)
Period 1: Lens 1, 15 Minutes STARTED	47	0
Period 1: Lens 1, 15 Minutes COMPLETED	47	0
Period 1: Lens 1, 15 Minutes NOT COMPLETED	0	0
Period 2: Lens 2, 15 Minutes STARTED	0	47
Period 2: Lens 2, 15 Minutes COMPLETED	0	47
Period 2: Lens 2, 15 Minutes NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=47 Participants Includes study participants that completed all study visits
Age, Continuous	55.0 years STANDARD_DEVIATION 6.7 • n=47 Participants
Sex: Female, Male Female	29 Participants n=47 Participants
Sex: Female, Male Male	18 Participants n=47 Participants

PRIMARY outcome

Timeframe: 15 Minutes

Subjective Overall Score was assessed using the 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=47 Participants Participants that received Lens 1	Lens 2 n=47 Participants Participants that received Lens 2
Subjective Overall Score	71.4 score on a scale Standard Deviation 18.0	80.3 score on a scale Standard Deviation 14.7

SECONDARY outcome

Timeframe: 15 Minutes

Subjective Comfort Score was assessed using the 0-100 visual analogue scale where 0=Extremely uncomfortable, causes pain, cannot be tolerated and 100=Excellent, cannot be felt

Outcome measures

Outcome measures
Measure	Lens 1 n=47 Participants Participants that received Lens 1	Lens 2 n=47 Participants Participants that received Lens 2
Subjective Comfort	75.0 score on a scale Standard Deviation 20.9	88.9 score on a scale Standard Deviation 12.2

SECONDARY outcome

Timeframe: 15 Minutes

Subjective Vision Score (distance and near) was assessed using the 0-100 visual analogue scale where 0=Unacceptable, cannot be worn and 100=Excellent, unaware of any visual loss

Outcome measures

Outcome measures
Measure	Lens 1 n=47 Participants Participants that received Lens 1	Lens 2 n=47 Participants Participants that received Lens 2
Subjective Vision Distance Vision	72.3 score on a scale Standard Deviation 17.1	78.4 score on a scale Standard Deviation 15.8
Subjective Vision Near Vision	77.4 score on a scale Standard Deviation 18.2	79.6 score on a scale Standard Deviation 15.7

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, PhD, MSc, FAAO

CooperVision Inc.

Phone: +19256213761

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place