Trial Outcomes & Findings for A Clinical Comparison of Two Soft Contact Lenses (C24-755) (NCT NCT06758076)

Results Overview

The primary outcome measure for this study is the subjective overall score on a scale of 0-100 (0= Extremely poor, unmanageable, cannot use lenses, 100= Excellent, highly impressed with these lenses overall).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

52 participants

Primary outcome timeframe

At the end of 15 minutes of daily wear

Results posted on

2026-07-08

Participant Flow

Fifty Two participants were screened. All the participants who were eligible (n=50) in the study were included in the analysis.

Participant milestones

Participant milestones
Measure	Lens 1 (Ocufilcon D) Then Lens 2 (Somofilcon A) All participants received Lens 1 (ocufilcon D) for 15 minutes in Period 1, followed by Lens 2 (somofilcon A) for 15 minutes in Period 2.
Period 1: Lens 1 (ocufilcon D) 15minutes STARTED	52
Period 1: Lens 1 (ocufilcon D) 15minutes COMPLETED	50
Period 1: Lens 1 (ocufilcon D) 15minutes NOT COMPLETED	2
Period 2: Lens 2 (somoflcon A) 15minutes STARTED	50
Period 2: Lens 2 (somoflcon A) 15minutes COMPLETED	50
Period 2: Lens 2 (somoflcon A) 15minutes NOT COMPLETED	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Lens 1 (Ocufilcon D) Then Lens 2 (Somofilcon A) All participants received Lens 1 (ocufilcon D) for 15 minutes in Period 1, followed by Lens 2 (somofilcon A) for 15 minutes in Period 2.
Period 1: Lens 1 (ocufilcon D) 15minutes Severe environmental allergies	1
Period 1: Lens 1 (ocufilcon D) 15minutes Eligibility Criteria	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=50 Participants Includes all study participants
Age, Continuous	41.3 Years STANDARD_DEVIATION 14.9 • n=50 Participants
Sex: Female, Male Female	34 Participants n=50 Participants
Sex: Female, Male Male	16 Participants n=50 Participants

PRIMARY outcome

Timeframe: At the end of 15 minutes of daily wear

The primary outcome measure for this study is the subjective overall score on a scale of 0-100 (0= Extremely poor, unmanageable, cannot use lenses, 100= Excellent, highly impressed with these lenses overall).

Outcome measures

Outcome measures
Measure	Lens 1 (Ocufilcon D) n=50 Participants All participants will wear lens 1 for 15 minutes (Period 1). Lens 1 (ocufilcon D): 15 minutes of daily wear	Lens 2 (Somofilcon A) n=50 Participants All participants will wear lens 2 for 15 minutes (Period 2). Lens 2 (somofilcon A): 15 minutes of daily wear
Subjective Overall Score	80.8 Units on Scale Standard Deviation 16.4	82.9 Units on Scale Standard Deviation 15.9

SECONDARY outcome

Timeframe: At the end of 15 minutes of daily wear

The secondary outcome measure for this study is the subjective vision on a scale of 0-100 (0= Extremely poor, intolerable, lenses cannot be worn, 100= Excellent, unaware of any visual loss).

Outcome measures

Outcome measures
Measure	Lens 1 (Ocufilcon D) n=50 Participants All participants will wear lens 1 for 15 minutes (Period 1). Lens 1 (ocufilcon D): 15 minutes of daily wear	Lens 2 (Somofilcon A) n=50 Participants All participants will wear lens 2 for 15 minutes (Period 2). Lens 2 (somofilcon A): 15 minutes of daily wear
Subjective Vision	80.9 units on a scale Standard Deviation 17.6	83.1 units on a scale Standard Deviation 15.9

SECONDARY outcome

Timeframe: At the end of 15 minutes of daily wear

The secondary outcome measure for this study is the subjective comfort on a scale of 0-100 (0= Extremely uncomfortable, causes pain, cannot be tolerated, 100= Excellent, cannot be felt).

Outcome measures

Outcome measures
Measure	Lens 1 (Ocufilcon D) n=50 Participants All participants will wear lens 1 for 15 minutes (Period 1). Lens 1 (ocufilcon D): 15 minutes of daily wear	Lens 2 (Somofilcon A) n=50 Participants All participants will wear lens 2 for 15 minutes (Period 2). Lens 2 (somofilcon A): 15 minutes of daily wear
Subjective Comfort	87.6 units on a scale Standard Deviation 15.5	84.5 units on a scale Standard Deviation 19.0

Adverse Events

Lens 1 (Ocufilcon D)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lens 2 (Somofilcon A)

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 Vega

CooperVision, Inc.

Phone: 9256213761

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place