Centre for Ocular Research & Education
Waterloo, Ontario, N2L 3G1, Canada
NCT Number: NCT04857723
The purpose of this study was to assess whether young adults could adapt to and achieve satisfaction with a daily disposable contact lens.
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Notify Me17 year–25 year
All sexes
Interventional
Waterloo, Ontario, N2L 3G1, Canada
This was a prospective, single group, dispensing clinical trial to determine subjective and objective visual performance measures, patient satisfaction and adaptability to a commercially available daily disposable contact lens in myopic young adults over 3 months of daily lens wear.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Daily disposable contact lens for 3 months
Time frame: 3 months
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.
Time frame: 3 months
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.
CooperVision, Inc.
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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