Trial Outcomes & Findings for Adaptation To and Satisfaction With Contact Lens Wear In Myopic Young Adults (NCT NCT04857723)

Results Overview

The Subjective Quality of Vision (QoV) questionnaire consisted of 30 items assessing 10 visual symptoms. Each symptom was evaluated using three sub-questions: frequency, severity, and bothersomeness. All subquestions were rated on a 4-point scale from 0 to 3, where higher values represent a higher severity, frequency, or bothersomeness. For analysis, each dimension-frequency, severity, and bothersomeness-was treated independently. Scores for each were calculated by summing the responses across all 10 symptoms, resulting in separate total scores for each dimension. Each total score ranged from 0 to 30. Thus, the Overall Frequency of Symptoms, Overall Severity, and Overall Bothersomeness scores each represent the sum of the respective ratings across all visual symptoms.

Recruitment status

COMPLETED

Target enrollment

29 participants

Primary outcome timeframe

3 months

Results posted on

2025-07-14

Participant Flow

Participant milestones

Participant milestones
Measure	Daily Disposable Contact Lens Participants wore a daily disposable contact lens for 3 months.
Overall Study STARTED	29
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Daily Disposable Contact Lens Participants wore a daily disposable contact lens for 3 months.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Daily Disposable Contact Lens n=29 Participants Participants wore a daily disposable contact lens for 3 months.
Age, Continuous	22.5 years STANDARD_DEVIATION 1.7 • n=29 Participants
Sex: Female, Male Female	25 Participants n=29 Participants
Sex: Female, Male Male	4 Participants n=29 Participants

PRIMARY outcome

Timeframe: 3 months

Population: The 2 discontinuations occurred after lens dispensing but prior to the first follow up visit. These participants were excluded from the data analysis population.

The Subjective Quality of Vision (QoV) questionnaire consisted of 30 items assessing 10 visual symptoms. Each symptom was evaluated using three sub-questions: frequency, severity, and bothersomeness. All subquestions were rated on a 4-point scale from 0 to 3, where higher values represent a higher severity, frequency, or bothersomeness. For analysis, each dimension-frequency, severity, and bothersomeness-was treated independently. Scores for each were calculated by summing the responses across all 10 symptoms, resulting in separate total scores for each dimension. Each total score ranged from 0 to 30. Thus, the Overall Frequency of Symptoms, Overall Severity, and Overall Bothersomeness scores each represent the sum of the respective ratings across all visual symptoms.

Outcome measures

Outcome measures
Measure	Daily Disposable Contact Lens n=27 Participants Participants wore a daily disposable contact lens for 3 months.
Subjective Quality of Vision (QoV) Overall Frequency	6.1 score on a scale Standard Deviation 3.6
Subjective Quality of Vision (QoV) Overall Severity	5.3 score on a scale Standard Deviation 3.5
Subjective Quality of Vision (QoV) Overall Bothersomeness	4.7 score on a scale Standard Deviation 4.1

SECONDARY outcome

Timeframe: 3 months

Population: The 2 discontinuations occurred after lens dispensing but prior to the first follow up visit. These participants were excluded from the data analysis population.

Participant quality of life was measured after 3 months of lens wear using a CLIQ 28-item questionnaire. Each question was scored on a 1-5 integer scale, where 1=never and 5=always. As written, scores were not consistently associated with a better or worse outcome. An algorithm was later applied for consistency (i.e., for categories \[1,2,3,4,5\], for the first 20 questions \[5,4,3,3,3\] are assigned and for 21-28 \[2,2,3,4,5\]). After the conversion, the average of all scores was used to measure the CLIQ. The CLIQ score ranged from a minimum of 2.71 to a maximum of 5, with 5 representing the best score.

Outcome measures

Outcome measures
Measure	Daily Disposable Contact Lens n=27 Participants Participants wore a daily disposable contact lens for 3 months.
Contact Lens Impact on Quality of Life (CLIQ)	4.1 score on a scale Standard Deviation 0.5

Adverse Events

Daily Disposable Contact Lens

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Daily Disposable Contact Lens n=27 participants at risk Participants wore a daily disposable contact lens for 3 months.
Eye disorders Corneal infiltrates	3.7% 1/27 • Number of events 1 • The duration of the study, approximately 3 months.
General disorders Burn	3.7% 1/27 • Number of events 1 • The duration of the study, approximately 3 months.
Eye disorders Corneal staining	3.7% 1/27 • Number of events 1 • The duration of the study, approximately 3 months.
Infections and infestations COVID-19	3.7% 1/27 • Number of events 1 • The duration of the study, approximately 3 months.

Additional Information

Paul Chamberlain

CooperVision Inc.

Phone: +19257306754

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place