Adaptation To and Satisfaction With Contact Lens Wear In Myopic Young Adults

CooperVision, Inc.29 enrolled

Overview

The purpose of this study was to assess whether young adults could adapt to and achieve satisfaction with a daily disposable contact lens.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myopia

Interventions

daily disposable contact lensDEVICE

Daily disposable contact lens for 3 months

Eligibility

Sex: ALLMin age: 17 YearsMax age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Is between 17 and 25 years of age (inclusive) and has full legal capacity to volunteer; * Has read and signed an information consent letter; * Is willing and able to follow instructions and maintain the appointment schedule; * Has a vertex corrected spherical equivalent distance refraction that ranges between - 0.75D to -6.00D in each eye; * Has astigmatism ≤ -0.75 DC in either eye, by refraction; * Be correctable to better than 0.20 logMAR in each eye by refraction; * Has habitually worn spherical soft contact lenses to correct for distance vision (i.e. no multifocal or monovision) for the past 3 months; * Is willing to wear contact lenses for at least 10 hours a day, 6 days a week while in the study; * Demonstrates an acceptable fit with the study lenses; * Has ocular health findings considered to be "normal" and which would not prevent the participant from safely wearing contact lenses. Exclusion Criteria: * Is participating in any concurrent clinical or research study; * Has a history of amblyopia; * Has TNO Stereoacuity worse than 120" arc / or Titmus worse than 100" arc; * Has any known active ocular disease and/or infection; * Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; * Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; * Has known sensitivity to the diagnostic pharmaceutical (sodium fluorescein) to be used in the study; * Is pregnant, lactating or planning a pregnancy at the time of enrolment (verbal confirmation at the screening visit); * Is pseudophakic; * Has undergone refractive error surgery; * Has one of following experiences with MiSight lenses: * Is currently wearing MiSight lenses or * Has worn MiSight lenses for more than one week at any given time or * Has worn MiSight lenses for any more than 30 minutes in the past 30 days; * Has had orthokeratology treatment within the last 3 months.

Locations (1)

Centre for Ocular Research & Education

Waterloo, Ontario, Canada

Outcomes

Primary Outcomes

Subjective Quality of Vision (QoV)

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

Secondary Outcomes

Contact Lens Impact on Quality of Life (CLIQ)

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.

Time frame: 3 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.