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Trial Outcomes & Findings for Clinical Evaluation of Proclear Toric and Biofinity Toric (NCT NCT06431061)

NCT ID: NCT06431061

Last Updated: 2025-09-15

Results Overview

Overall fit acceptance will be measured on scale of (0-4) where (0=Should not be worn and 4=Perfect)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

37 participants

Primary outcome timeframe

After 15 minutes of continuous wear

Results posted on

2025-09-15

Participant Flow

Thirty-eight Participants were screened. One Participant was not eligible due to screening failure. All the participants who were eligible in the study were included in the analysis. (n=37)

Participant milestones

Participant milestones
Measure
Lens A (Omafilcon B)
All participants wore lens A for 15 minutes (Period 1). Lens A (omafilcon B): 15 minutes of daily wear.
Lens B (Comfilcon A)
All participants wore lens B for 15 minutes (Period 2). Lens B (comfilcon A): 15 minutes of daily wear.
Period 1: Lens A (15 Minutes)
STARTED
37
0
Period 1: Lens A (15 Minutes)
COMPLETED
37
0
Period 1: Lens A (15 Minutes)
NOT COMPLETED
0
0
Period 2: Lens B (15 Minutes)
STARTED
0
37
Period 2: Lens B (15 Minutes)
COMPLETED
0
37
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=37 Participants
Includes all Study Participants
Age, Continuous
29.6 years
STANDARD_DEVIATION 13.0 • n=37 Participants
Sex: Female, Male
Female
32 Participants
n=37 Participants
Sex: Female, Male
Male
5 Participants
n=37 Participants

PRIMARY outcome

Timeframe: After 15 minutes of continuous wear

Population: All the participants who were eligible in the study were included in the analysis. (n=37)

Overall fit acceptance will be measured on scale of (0-4) where (0=Should not be worn and 4=Perfect)

Outcome measures

Outcome measures
Measure
Lens A (Omafilcon B)
n=37 Participants
All participants wore lens A for 15 minutes (Period 1). Lens A (omafilcon B): 15 minutes of daily wear.
Lens B (Comfilcon A)
n=37 Participants
All participants wore lens B for 15 minutes (Period 2). Lens B (comfilcon A): 15 minutes of daily wear.
Overall Fit Acceptance
3.5 Units on Scale
Standard Deviation 0.7
3.8 Units on Scale
Standard Deviation 0.4

Adverse Events

Lens A (Omafilcon B)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Lens B (Comfilcon 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: 925-621-3761

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place