Trial Outcomes & Findings for A Clinical Performance of Two Soft Toric Contact Lenses (NCT NCT05633082)

NCT ID: NCT05633082

Last Updated: 2023-11-07

Results Overview

The subjective overall impression of the contact lens (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Extremely poor, 100=Excellent.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: 15 minutes
• Results posted on: 2023-11-07

Participant Flow

Participant milestones

Measure	Lens 1 (Omafilcon B) All participants wore Lens 1 for 15 minutes (Period 1)	Lens 2 (Fanfilcon A) All participants wore Lens 2 for 15 minutes (Period 2)
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

Measure	All Study Participants n=40 Participants Includes all study participants.
Age, Continuous	40.9 years STANDARD_DEVIATION 14.1 • n=40 Participants
Sex: Female, Male Female	25 Participants n=40 Participants
Sex: Female, Male Male	15 Participants n=40 Participants

PRIMARY outcome

Timeframe: 15 minutes

The subjective overall impression of the contact lens (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Extremely poor, 100=Excellent.

Outcome measures

Measure	Lens 1 n=40 Participants Participants that received Lens 1	Lens 2 n=40 Participants Participants that received Lens 2
Subjective Overall Score	71.6 score on a scale Standard Deviation 20.2	78.9 score on a scale Standard Deviation 16.2

SECONDARY outcome

Timeframe: 15 minutes

Subjective comfort (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Causes pain,100=Excellent.

Outcome measures

Measure	Lens 1 n=40 Participants Participants that received Lens 1	Lens 2 n=40 Participants Participants that received Lens 2
Subjective Comfort	74.6 score on a scale Standard Deviation 19.5	85.0 score on a scale Standard Deviation 15.0

SECONDARY outcome

Timeframe: 15 minutes

Subjective vision (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Unacceptable,100=Excellent.

Outcome measures

Measure	Lens 1 n=40 Participants Participants that received Lens 1	Lens 2 n=40 Participants Participants that received Lens 2
Subjective Vision	76.6 score on a scale Standard Deviation 19.4	78.8 score on a scale Standard Deviation 16.6

Adverse Events

Lens 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lens 2

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

José A. Vega OD, MSc, FAAO

CooperVision Inc.

Phone: +19256213761

Email: jvega2@coopervision.com

Results disclosure agreements

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