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Trial Outcomes & Findings for Clinical Evaluation of Two Daily Disposable Lenses in Sphere Design (NCT NCT05516082)

NCT ID: NCT05516082

Last Updated: 2023-11-28

Results Overview

Measured on a scale of 0-4 (0 = Should not be worn, 1 = Borderline but unacceptable, 2 = Min. acceptable, early review, 3 = Not perfect but OK to dispense, 4 = Perfect) as assessed by an investigator.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

41 participants

Primary outcome timeframe

15 minutes

Results posted on

2023-11-28

Participant Flow

Participant milestones

Participant milestones
Measure
Lens A (DDH Contact Lens)
All participants wore Lens A for 15 minutes (Period 1)
Lens B (DDSH Contact Lens)
All participants wore Lens B for 15 minutes (Period 2)
Period 1: Lens A, 15 Minutes
STARTED
41
0
Period 1: Lens A, 15 Minutes
COMPLETED
41
0
Period 1: Lens A, 15 Minutes
NOT COMPLETED
0
0
Period 2: Lens B, 15 Minutes
STARTED
0
41
Period 2: Lens B, 15 Minutes
COMPLETED
0
41
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=41 Participants
Includes all study participants.
Age, Continuous
28.6 years
STANDARD_DEVIATION 9.9 • n=41 Participants
Sex: Female, Male
Female
33 Participants
n=41 Participants
Sex: Female, Male
Male
8 Participants
n=41 Participants

PRIMARY outcome

Timeframe: 15 minutes

Population: All participants wore Lens A and Lens B in sequential order.

Measured on a scale of 0-4 (0 = Should not be worn, 1 = Borderline but unacceptable, 2 = Min. acceptable, early review, 3 = Not perfect but OK to dispense, 4 = Perfect) as assessed by an investigator.

Outcome measures

Outcome measures
Measure
Lens A
n=41 Participants
Participants that received Lens A.
Lens B
n=41 Participants
Participants that received Lens B.
Lens Fit Acceptance
3.51 score on a scale
Standard Deviation 0.9
3.68 score on a scale
Standard Deviation 0.7

Adverse Events

Lens A

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

Lens B

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

Results disclosure agreements

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