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Trial Outcomes & Findings for Clinical Evaluation of Biomedics Monthly Sphere and Avaira Vitality Sphere (NCT NCT06400914)

NCT ID: NCT06400914

Last Updated: 2025-08-15

Results Overview

Overall lens fit acceptance was measured on a scale from 0-4 (0=Should not be worn and 4= Perfect)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

At the end of 15 Minutes of wear

Results posted on

2025-08-15

Participant Flow

Forty-four participants were screened and dispensed lenses. All participants who were dispensed with lenses completed the study. (n=44)

Participant milestones

Participant milestones
Measure
Lens A (Ocufilcon D)
All participants wore lens A for 15 minutes (Period 1). Lens A (ocufilcon D): 15 minutes of daily wear.
Lens B (Fanfilcon A)
All participants wore lens B for 15 minutes (Period 2). Lens B (fanfilcon A): 15 minutes of daily wear.
Period 1: Lens A (15 Minutes)
STARTED
44
0
Period 1: Lens A (15 Minutes)
COMPLETED
44
0
Period 1: Lens A (15 Minutes)
NOT COMPLETED
0
0
Period 2: Lens B (15 Minutes)
STARTED
0
44
Period 2: Lens B (15 Minutes)
COMPLETED
0
44
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=44 Participants
Includes all study participants
Age, Continuous
27.7 years
STANDARD_DEVIATION 9.0 • n=44 Participants
Sex: Female, Male
Female
36 Participants
n=44 Participants
Sex: Female, Male
Male
8 Participants
n=44 Participants

PRIMARY outcome

Timeframe: At the end of 15 Minutes of wear

Population: All the forty-four participants who started the study, completed the study.

Overall lens fit acceptance was measured on a scale from 0-4 (0=Should not be worn and 4= Perfect)

Outcome measures

Outcome measures
Measure
Lens A (Ocufilcon D)
n=44 Participants
All participants wore lens A for 15 minutes (Period 1). Lens A (ocufilcon D): 15 minutes of daily wear.
Lens B (Fanfilcon A)
n=44 Participants
All participants wore lens B for 15 minutes (Period 2). Lens B (fanfilcon A): 15 minutes of daily wear.
Lens Fit Acceptance Ratings
3.3 Units on Scale
Standard Deviation 1.1
3.7 Units on Scale
Standard Deviation 0.8

Adverse Events

Lens A (Ocufilcon D)

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

Lens B (Fanfilcon 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, FAAO

CooperVision, Inc.

Phone: 925-621-3761

Results disclosure agreements

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