Trial Outcomes & Findings for A Clinical Comparison of Two Soft Toric Contact Lenses (NCT NCT06758089)

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

42 participants

Primary outcome timeframe

At the end of 15 minutes of daily wear

Results posted on

2026-02-18

Participant Flow

Forty-two participants were screened. Two participants were not eligible due to screening failure. All the participants who were eligible in the study were included in the analysis. (n=40)

Participant milestones

Participant milestones
Measure	Lens 1 (Ocufilcon D) All participants wore Lens 1 for 15 minutes (Period 1). Lens 1 (ocufilcon D): 15 minutes of daily wear	Lens 2 (Somofilcon A) All participants wore Lens 2 for 15 minutes (Period 2). Lens 2 (somofilcon A): 15 minutes of daily wear
Period 1: Lens 1 (15 Minutes) STARTED	40	0
Period 1: Lens 1 (15 Minutes) COMPLETED	40	0
Period 1: Lens 1 (15 Minutes) NOT COMPLETED	0	0
Period 2: Lens 2 (15 Minutes) STARTED	0	40
Period 2: Lens 2 (15 Minutes) COMPLETED	0	40
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=40 Participants Includes all eligible Study Participants
Age, Continuous	37.2 Years STANDARD_DEVIATION 13.4 • n=40 Participants
Sex: Female, Male Female	26 Participants n=40 Participants
Sex: Female, Male Male	14 Participants n=40 Participants

PRIMARY outcome

Timeframe: At the end of 15 minutes of daily wear

Population: All the participants who were eligible in the study were included in the analysis. (n=40)

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=40 Participants All participants wore Lens 1 for 15 minutes (Period 1). Lens 1 (ocufilcon D): 15 minutes of daily wear	Lens 2 (Somofilcon A) n=40 Participants All participants wore Lens 2 for 15 minutes (Period 2). Lens 2 (somofilcon A): 15 minutes of daily wear
Subjective Overall Score	76.5 units on a scale Standard Deviation 17.9	75.5 units on a scale Standard Deviation 16.3

SECONDARY outcome

Timeframe: At the end of 15 minutes of daily wear

Population: All the participants who were eligible in the study were included in the analysis. (n=40)

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=40 Participants All participants wore Lens 1 for 15 minutes (Period 1). Lens 1 (ocufilcon D): 15 minutes of daily wear	Lens 2 (Somofilcon A) n=40 Participants All participants wore Lens 2 for 15 minutes (Period 2). Lens 2 (somofilcon A): 15 minutes of daily wear
Subjective Vision	78.9 units on a scale Standard Deviation 16.9	73.8 units on a scale Standard Deviation 16.8

SECONDARY outcome

Timeframe: At the end of 15 minutes of daily wear

Population: All the participants who were eligible in the study were included in the analysis. (n=40)

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=40 Participants All participants wore Lens 1 for 15 minutes (Period 1). Lens 1 (ocufilcon D): 15 minutes of daily wear	Lens 2 (Somofilcon A) n=40 Participants All participants wore Lens 2 for 15 minutes (Period 2). Lens 2 (somofilcon A): 15 minutes of daily wear
Subjective Comfort	80.1 units on a scale Standard Deviation 16.3	82.3 units on a scale Standard Deviation 13.7

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 A Vega, OD, MSc, PhD

CooperVision Inc.

Phone: 9256213761

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place