Trial Outcomes & Findings for Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses (NCT NCT05656885)

Results Overview

Measured on lens fit alone on a scale of 0-4 (0=Should not be used; 1=Limit, but unacceptable; 2=Minimum acceptable, early review; 3=Not perfect, but OK to dispense; 4=Perfect) as assessed by an investigator.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

15 minutes

Results posted on

2023-12-27

Participant Flow

Participant milestones

Participant milestones
Measure	Lens A (Hydrogel Contact Lens) All participants wore Lens A for 15 minutes (Period 1)	Lens B (Silicone Hydrogel Contact Lens) All participants wore Lens B for 15 minutes (Period 2)
Period 1: Lens A, 15 Minutes STARTED	40	0
Period 1: Lens A, 15 Minutes COMPLETED	40	0
Period 1: Lens A, 15 Minutes NOT COMPLETED	0	0
Period 2: Lens B, 15 Minutes STARTED	0	40
Period 2: Lens B, 15 Minutes COMPLETED	0	40
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 Participants n=40 Participants All participants who enrolled and completed all study visits.
Age, Continuous	24.68 years STANDARD_DEVIATION 4.57 • n=40 Participants
Sex: Female, Male Female	31 Participants n=40 Participants
Sex: Female, Male Male	9 Participants n=40 Participants

PRIMARY outcome

Timeframe: 15 minutes

Population: All participants received Lens A and Lens B in sequential order.

Measured on lens fit alone on a scale of 0-4 (0=Should not be used; 1=Limit, but unacceptable; 2=Minimum acceptable, early review; 3=Not perfect, but OK to dispense; 4=Perfect) as assessed by an investigator.

Outcome measures

Outcome measures
Measure	Lens A n=40 Participants All participants that wore Lens A	Lens B n=40 Participants All participants that wore Lens B
Lens Fit Acceptance Rating	3.28 score on a scale Standard Deviation 0.60	3.48 score on a scale Standard Deviation 0.60

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

Dr. Jose 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