Trial Outcomes & Findings for Multi-center Clinical Evaluation of PC 1-Day vs 1-Day Acuvue Moist (NCT NCT02024698)

Results Overview

Subjective Assessment of comfort on insertion at baseline for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very uncomfortable, 10=cannot feel)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

43 participants

Primary outcome timeframe

Baseline

Results posted on

2020-07-30

Participant Flow

Participant milestones

Participant milestones
Measure	Etafilcon A First, Then Omafilcon A Study participants are randomized to wear etafilcon A pair of study lenses then crossover to the alternate pair.	Omafilcon A First, Then Etafilcon A Study participants are randomized to wear omafilcon A pair of study lenses then crossover to the alternate pair.
First Intervention (7 Days) STARTED	16	27
First Intervention (7 Days) COMPLETED	16	26
First Intervention (7 Days) NOT COMPLETED	0	1
Second Intervention (7 Days) STARTED	16	26
Second Intervention (7 Days) Received Etafilcon A Twice	1	0
Second Intervention (7 Days) COMPLETED	16	26
Second Intervention (7 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Etafilcon A First, Then Omafilcon A Study participants are randomized to wear etafilcon A pair of study lenses then crossover to the alternate pair.	Omafilcon A First, Then Etafilcon A Study participants are randomized to wear omafilcon A pair of study lenses then crossover to the alternate pair.
First Intervention (7 Days) Withdrawal by Subject	0	1

Baseline Characteristics

Multi-center Clinical Evaluation of PC 1-Day vs 1-Day Acuvue Moist

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study Group n=43 Participants Study participants are randomized to wear omafilcon A or etafilcon A pair of study lenses then crossover to the alternate pair.
Age, Continuous	28.1 years STANDARD_DEVIATION 5.03 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Subjective Assessment of comfort on insertion at baseline for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very uncomfortable, 10=cannot feel)

Outcome measures

Outcome measures
Measure	Omafilcon A n=42 Participants Study participants are randomized to wear omafilcon A lenses. Omafilcon A: contact lens	Etafilcon A n=43 Participants Study participants are randomized to wear etafilcon A lenses. Etafilcon A: contact lens
Comfort (Subjective Assessment)	9.12 units on a scale Standard Deviation 1.17	9.16 units on a scale Standard Deviation 1.17

PRIMARY outcome

Timeframe: 1 Week

Population: One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.

Subjective Assessment: Insertion Comfort, Comfort During Day, Comfort Prior to Removal, Comfort Overall for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very uncomfortable, 10=cannot feel)

Outcome measures

Outcome measures
Measure	Omafilcon A n=41 Participants Study participants are randomized to wear omafilcon A lenses. Omafilcon A: contact lens	Etafilcon A n=43 Participants Study participants are randomized to wear etafilcon A lenses. Etafilcon A: contact lens
Comfort (Subjective Assessment) Insertion Comfort	9.15 units on a scale Standard Deviation 1.24	8.65 units on a scale Standard Deviation 1.77
Comfort (Subjective Assessment) Comfort During Day	8.12 units on a scale Standard Deviation 2.00	8.63 units on a scale Standard Deviation 1.50
Comfort (Subjective Assessment) Comfort Prior to Removal	7.20 units on a scale Standard Deviation 2.63	7.70 units on a scale Standard Deviation 1.95
Comfort (Subjective Assessment) Comfort Overall	7.84 units on a scale Standard Deviation 1.75	8.28 units on a scale Standard Deviation 1.58

PRIMARY outcome

Timeframe: Baseline

Subjective Assessment of hydration on insertion at baseline for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dehydrated, not hydrophilic, very dry, 10=very hydrated, ultra hydrophilic)

Outcome measures

Outcome measures
Measure	Omafilcon A n=42 Participants Study participants are randomized to wear omafilcon A lenses. Omafilcon A: contact lens	Etafilcon A n=43 Participants Study participants are randomized to wear etafilcon A lenses. Etafilcon A: contact lens
Hydration (Subjective Assessment)	9.21 units on a scale Standard Deviation 1.02	9.35 units on a scale Standard Deviation 1.09

PRIMARY outcome

Timeframe: 1 Week

Population: One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.

Subjective Assessment: Initial Hydration, Hydration During Day, Hydration Prior to Removal for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dehydrated, not hydrophilic, very dry, 10=very hydrated, ultra hydrophilic)

Outcome measures

Outcome measures
Measure	Omafilcon A n=41 Participants Study participants are randomized to wear omafilcon A lenses. Omafilcon A: contact lens	Etafilcon A n=43 Participants Study participants are randomized to wear etafilcon A lenses. Etafilcon A: contact lens
Hydration (Subjective Assessment) Initial Hydration	9.41 units on a scale Standard Deviation 1.00	8.84 units on a scale Standard Deviation 1.41
Hydration (Subjective Assessment) Hydration During Day	8.02 units on a scale Standard Deviation 1.88	8.47 units on a scale Standard Deviation 1.37
Hydration (Subjective Assessment) Hydration Prior to Removal	7.32 units on a scale Standard Deviation 2.44	7.53 units on a scale Standard Deviation 1.91

PRIMARY outcome

Timeframe: Baseline

Subjective Assessment: Visual quality on insertion at baseline for each pair using questionnaire and rated on subjective response scale (0-10; 0= clear vision, 10=perfectly sharp)

Outcome measures

Outcome measures
Measure	Omafilcon A n=42 Participants Study participants are randomized to wear omafilcon A lenses. Omafilcon A: contact lens	Etafilcon A n=43 Participants Study participants are randomized to wear etafilcon A lenses. Etafilcon A: contact lens
Vision Quality (Subjective Assessment)	9.33 units on a scale Standard Deviation 1.59	9.16 units on a scale Standard Deviation 1.79

PRIMARY outcome

Timeframe: 1 Week

Population: One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.

Subjective Assessment: Vision Satisfaction for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very unsatisfied, 10=very satisfied)

Outcome measures

Outcome measures
Measure	Omafilcon A n=41 Participants Study participants are randomized to wear omafilcon A lenses. Omafilcon A: contact lens	Etafilcon A n=43 Participants Study participants are randomized to wear etafilcon A lenses. Etafilcon A: contact lens
Vision Satisfaction (Subjective Assessment)	9.07 units on a scale Standard Deviation 1.46	9.05 units on a scale Standard Deviation 1.34

PRIMARY outcome

Timeframe: 1 Week

Population: One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.

Subjective Assessment: Dryness During Day, Dryness Prior to Removal, Overall Dryness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dry, 10=no dryness)

Outcome measures

Outcome measures
Measure	Omafilcon A n=41 Participants Study participants are randomized to wear omafilcon A lenses. Omafilcon A: contact lens	Etafilcon A n=43 Participants Study participants are randomized to wear etafilcon A lenses. Etafilcon A: contact lens
Dryness (Subjective Assessment) Dryness During Day	8.05 units on a scale Standard Deviation 1.92	8.58 units on a scale Standard Deviation 1.48
Dryness (Subjective Assessment) Dryness Prior to Removal	7.24 units on a scale Standard Deviation 2.43	7.70 units on a scale Standard Deviation 1.78
Dryness (Subjective Assessment) Overall Dryness	7.71 units on a scale Standard Deviation 2.06	8.14 units on a scale Standard Deviation 1.71

PRIMARY outcome

Timeframe: 1 Week

Population: One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.

Subjective Assessment: Handling on Insertion and Removal, Overall Handling for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very difficult, 10=very easy)

Outcome measures

Outcome measures
Measure	Omafilcon A n=41 Participants Study participants are randomized to wear omafilcon A lenses. Omafilcon A: contact lens	Etafilcon A n=43 Participants Study participants are randomized to wear etafilcon A lenses. Etafilcon A: contact lens
Handling (Subjective Assessment) Insertion and Removal	8.85 units on a scale Standard Deviation 1.99	8.44 units on a scale Standard Deviation 1.79
Handling (Subjective Assessment) Overall	8.85 units on a scale Standard Deviation 1.99	8.51 units on a scale Standard Deviation 1.75

PRIMARY outcome

Timeframe: 1 Week

Population: One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.

Subjective Assessment: Eye Whiteness/Redness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= significant redness, 10=totally white)

Outcome measures

Outcome measures
Measure	Omafilcon A n=41 Participants Study participants are randomized to wear omafilcon A lenses. Omafilcon A: contact lens	Etafilcon A n=43 Participants Study participants are randomized to wear etafilcon A lenses. Etafilcon A: contact lens
Eye Whiteness/Redness (Subjective Assessment)	8.63 units on a scale Standard Deviation 1.65	9.26 units on a scale Standard Deviation 1.11

PRIMARY outcome

Timeframe: 1 Week

Population: One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.

Subjective Assessment: Overall sensation of smoothness at 1 week wear for each pair when asked "How would you rate the overall sensation of smoothness (deposit resistance) of the first study lenses, over the last week of wear?" (Likert 1-5; 1=excellent, 2=good, 3=average, 4=below average, 5=poor)

Outcome measures

Outcome measures
Measure	Omafilcon A n=41 Participants Study participants are randomized to wear omafilcon A lenses. Omafilcon A: contact lens	Etafilcon A n=43 Participants Study participants are randomized to wear etafilcon A lenses. Etafilcon A: contact lens
Overall Sensation of Smoothness (Subjective Assessment) Excellent	25 participants	24 participants
Overall Sensation of Smoothness (Subjective Assessment) Good	11 participants	7 participants
Overall Sensation of Smoothness (Subjective Assessment) Average	2 participants	9 participants
Overall Sensation of Smoothness (Subjective Assessment) Below Average	3 participants	3 participants
Overall Sensation of Smoothness (Subjective Assessment) Poor	0 participants	0 participants

PRIMARY outcome

Timeframe: 1 Week

Population: One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.

Subjective Assessment: Satisfaction overall at 1 Week wear for each pair when asked "Overall, how satisfied was the subject with the study lenses, during the last week, with regards to: Overall?" (Likert 1-4; 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied)

Outcome measures

Outcome measures
Measure	Omafilcon A n=41 Participants Study participants are randomized to wear omafilcon A lenses. Omafilcon A: contact lens	Etafilcon A n=43 Participants Study participants are randomized to wear etafilcon A lenses. Etafilcon A: contact lens
Overall Satisfaction for Lens Completely Satisfied	17 participants	21 participants
Overall Satisfaction for Lens Somewhat Satisfied	18 participants	14 participants
Overall Satisfaction for Lens Somewhat Dissatisfied	5 participants	7 participants
Overall Satisfaction for Lens Completely Dissatisfied	1 participants	1 participants

Adverse Events

Omafilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Etafilcon 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

Manager Global Medical/Scientific Affairs

CooperVision, Inc.

Phone: 925-621-3761

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.
Publication restrictions are in place

Restriction type: OTHER