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Trial Outcomes & Findings for Evaluating Two Multifocal Daily Disposable Contact Lenses (NCT NCT05579886)

NCT ID: NCT05579886

Last Updated: 2024-02-20

Results Overview

Subjective rating measured on a scale of 0-10, 0.5 steps, where 0=Painful, 10=Can't feel the lenses.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

2 weeks

Results posted on

2024-02-20

Participant Flow

Participant milestones

Participant milestones
Measure
Control Lens (2ADD)
All participants wore the Control Lens for 2 weeks (Period 1)
Test Lens (3ADD)
All participants wore the Test Lens for 2 weeks (Period 2)
Period 1: Control Lens, 2 Weeks
STARTED
60
0
Period 1: Control Lens, 2 Weeks
COMPLETED
60
0
Period 1: Control Lens, 2 Weeks
NOT COMPLETED
0
0
Period 2: Test Lens, 2 Weeks
STARTED
0
60
Period 2: Test Lens, 2 Weeks
COMPLETED
0
60
Period 2: Test Lens, 2 Weeks
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=60 Participants
Includes all study participants
Age, Continuous
52.9 years
STANDARD_DEVIATION 6.9 • n=60 Participants
Sex: Female, Male
Female
50 Participants
n=60 Participants
Sex: Female, Male
Male
10 Participants
n=60 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: All participants wore Control Lens and Test Lens in sequential order.

Subjective rating measured on a scale of 0-10, 0.5 steps, where 0=Painful, 10=Can't feel the lenses.

Outcome measures

Outcome measures
Measure
Control Lens (2ADD)
n=60 Participants
Participants that received Control Lens
Test Lens (3ADD)
n=60 Participants
Participants that received Test Lens
Comfort Just After Lens Insertion
9.1 score on a scale
Standard Deviation 1.4
9.2 score on a scale
Standard Deviation 1.1

Adverse Events

Control Lens (2ADD)

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Test Lens (3ADD)

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

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Control Lens (2ADD)
n=60 participants at risk
Participants that received Control Lens
Test Lens (3ADD)
n=60 participants at risk
Participants that received Test Lens
Infections and infestations
Influenza
1.7%
1/60 • Number of events 1 • From dispense to study exit, approximately 6-8 weeks.
0.00%
0/60 • From dispense to study exit, approximately 6-8 weeks.

Additional Information

José A. Vega OD, MSc, FAAO, PhD

CooperVision Inc.

Phone: 19256213761

Results disclosure agreements

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