Trial Outcomes & Findings for Clinical Validation of the Apollo Daily Disposable Soft Contact Lenses (NCT NCT05035017)

Results Overview

Participants rated their overall comfort once after 2 days of wear a 0-100 integer scale, where 0=Cannot be tolerated and 100=Excellent comfort.

Recruitment status

COMPLETED

Target enrollment

35 participants

Primary outcome timeframe

2 days

Results posted on

2024-08-12

Participant Flow

Participant milestones

Participant milestones
Measure	Test Lens, Then Control Lens Participants wore Test Lens for 2 days (Period 1), and then Control Lens for 2 days (Period 2)	Control Lens, Then Test Lens Participants wore Control Lens for 2 days (Period 1), and then Test Lens for 2 days (Period 2)
Period 1 (2 Days) STARTED	18	17
Period 1 (2 Days) COMPLETED	18	17
Period 1 (2 Days) NOT COMPLETED	0	0
Period 2 (2 Days) STARTED	18	17
Period 2 (2 Days) COMPLETED	18	17
Period 2 (2 Days) 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	Overall Study n=35 Participants All participants who were dispensed lenses and successfully completed the study
Age, Continuous	25.4 years STANDARD_DEVIATION 4.2 • n=35 Participants
Sex: Female, Male Female	27 Participants n=35 Participants
Sex: Female, Male Male	8 Participants n=35 Participants

PRIMARY outcome

Timeframe: 2 days

Participants rated their overall comfort once after 2 days of wear a 0-100 integer scale, where 0=Cannot be tolerated and 100=Excellent comfort.

Outcome measures

Outcome measures
Measure	Test Lens n=35 Participants Participants that received Test lens during either the first or second period of the study.	Control Lens n=35 Participants Participants that received Control lens during either the first or second period of the study.
Overall Comfort With Lens	86 score on a scale Standard Deviation 15	72 score on a scale Standard Deviation 26

SECONDARY outcome

Timeframe: 2 days

Participant response measured once after 2 days of wear on a 0-100 integer scale, where 0= Unacceptable, 100=Excellent Vision.

Outcome measures

Outcome measures
Measure	Test Lens n=35 Participants Participants that received Test lens during either the first or second period of the study.	Control Lens n=35 Participants Participants that received Control lens during either the first or second period of the study.
Overall Vision Quality	90 score on a scale Standard Deviation 11	91 score on a scale Standard Deviation 11

SECONDARY outcome

Timeframe: 2 days

Measured once after 2 days of wear by investigator on lens fit alone (excludes comfort, vision, orientation) on a 0-4 scale, 0.25 steps, where 0=Can't be worn and 4=Optimum

Outcome measures

Outcome measures
Measure	Test Lens n=35 Participants Participants that received Test lens during either the first or second period of the study.	Control Lens n=35 Participants Participants that received Control lens during either the first or second period of the study.
Overall Lens Fit Acceptance	3.11 score on a scale Standard Deviation 0.66	3.09 score on a scale Standard Deviation 0.70

SECONDARY outcome

Timeframe: 2 days

Participant response on overall handling (insertion, removal, and holding) of contact lenses assessed once after 2 days of wear, on the third day. Measured on a 0-100 integer scale, where 0=Cannot be managed, 100=Excellent handling.

Outcome measures

Outcome measures
Measure	Test Lens n=35 Participants Participants that received Test lens during either the first or second period of the study.	Control Lens n=35 Participants Participants that received Control lens during either the first or second period of the study.
Overall Lens Handling	88 score on a scale Standard Deviation 15	87 score on a scale Standard Deviation 14

SECONDARY outcome

Timeframe: 2 days

Assessed once after 2 days of wear with slit lamp biomicroscopy and graded on a 0-4 integer scale, where 0=No Staining and 4=\>45% of area. Lower values represented a better outcome, e.g., a grading value of 1 would represent less corneal staining than a grade of 4. Locations (central, nasal, temporal, superior, inferior) were graded separately.

Outcome measures

Outcome measures
Measure	Test Lens n=35 Participants Participants that received Test lens during either the first or second period of the study.	Control Lens n=35 Participants Participants that received Control lens during either the first or second period of the study.
Anterior Ocular Health - Corneal Staining Extent Central	0.10 score on a scale Standard Deviation 0.30	0.16 score on a scale Standard Deviation 0.44
Anterior Ocular Health - Corneal Staining Extent Nasal	0.11 score on a scale Standard Deviation 0.32	0.14 score on a scale Standard Deviation 0.39
Anterior Ocular Health - Corneal Staining Extent Temporal	0.10 score on a scale Standard Deviation 0.30	0.13 score on a scale Standard Deviation 0.34
Anterior Ocular Health - Corneal Staining Extent Superior	0.04 score on a scale Standard Deviation 0.20	0.06 score on a scale Standard Deviation 0.23
Anterior Ocular Health - Corneal Staining Extent Inferior	0.39 score on a scale Standard Deviation 0.52	0.41 score on a scale Standard Deviation 0.55

Adverse Events

Test Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Lens

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

Lee Hall BSc PhD MCOptom, FBCLA

CooperVision Inc.

Phone: 925-251-6884

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place