Trial Outcomes & Findings for Clinical Evaluation of Two Multifocal Contact Lenses (NCT NCT05457608)

Last Updated: 2023-12-20

Results Overview

Subjective comfort ratings on insertion were measured on a scale from 0 - 10, where 0= extremely uncomfortable and 10= can't feel.

Recruitment status

COMPLETED

Study phase

Target enrollment

42 participants

Primary outcome timeframe

At insertion

Results posted on

2023-12-20

Participant Flow

Forty-two participants were screened. All participants wore Lens A first for 15 minutes and then wore Lens B for 15 minutes. All the participants who were in the study were included in the analysis. (n=42)

Participant milestones

Participant milestones
Measure	Lens A All participants wore Lens A for 15 minutes. (Period 1)	Lens B All participants wore Lens B for 15 minutes. (Period 2)
Period 1: Lens A (15 Minutes) STARTED	42	0
Period 1: Lens A (15 Minutes) COMPLETED	42	0
Period 1: Lens A (15 Minutes) NOT COMPLETED	0	0
Period 2: Lens B (15 Minutes) STARTED	0	42
Period 2: Lens B (15 Minutes) COMPLETED	0	42
Period 2: Lens B (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=42 Participants Includes all study participants.
Age, Categorical Lens A · <=18 years	0 Participants n=42 Participants
Age, Categorical Lens A · Between 18 and 65 years	42 Participants n=42 Participants
Age, Categorical Lens A · >=65 years	0 Participants n=42 Participants
Age, Categorical Lens B · <=18 years	0 Participants n=42 Participants
Age, Categorical Lens B · Between 18 and 65 years	42 Participants n=42 Participants
Age, Categorical Lens B · >=65 years	0 Participants n=42 Participants
Sex: Female, Male Female	31 Participants n=42 Participants
Sex: Female, Male Male	11 Participants n=42 Participants

PRIMARY outcome

Timeframe: At insertion

Population: \[Not Specified\]

Subjective comfort ratings on insertion were measured on a scale from 0 - 10, where 0= extremely uncomfortable and 10= can't feel.

Outcome measures

Outcome measures
Measure	Lens A n=42 Participants Participants that received Lens A.	Lens B n=42 Participants Participants that received Lens B.
Subjective Comfort Ratings on Insertion	9.19 Units on scale Standard Deviation 0.86	9.47 Units on scale Standard Deviation 0.67

Adverse Events

Lens A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lens B

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

Jose A. Vega,OD,MSc,FAAO

CooperVision

Phone: 9256213761

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place