N/A Completed N=32 Treatment

Evaluating the Performance of Precision1 Daily Disposable Contact Lens in a Group of Heavy Digital Device Users

Myopia

Source: ClinicalTrials.gov NCT04201639 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2023

Primary outcomePrimary: Subjective Comfort After Contact Lens Insertion — 95 score on a scale

Summary

The purpose of this study is to evaluate the performance of Precision1 DD CLs with regard to subjective symptoms (dryness, comfort, vision), lens fit and time to haze in CL wearers who identify themselves as heavy digital devices users (at least 6 hours of digital device use per day).

Outcome Measures

Outcome	Result	p-value
PRIMARY Subjective Comfort After Contact Lens Insertion	90	—
PRIMARY Subjective Dryness After Contact Lens Insertion	90	—
PRIMARY Subjective Rating of Clarity of Vision After Contact Lens Insertion	91	—
PRIMARY Subjective Comfort After Contact Lens Insertion	90	—
PRIMARY Subjective Dryness After Contact Lens Insertion	90	—
PRIMARY Subjective Rating of Clarity of Vision After Contact Lens Insertion	91	—
PRIMARY Subjective Comfort After Contact Lens Insertion	90	—
PRIMARY Subjective Dryness After Contact Lens Insertion	90	—
PRIMARY Subjective Rating of Clarity of Vision After Contact Lens Insertion	91	—
PRIMARY Subjective Comfort After Contact Lens Insertion	90	—
PRIMARY Subjective Dryness After Contact Lens Insertion	90	—
PRIMARY Subjective Rating of Clarity of Vision After Contact Lens Insertion	91	—
PRIMARY Subjective Comfort After Contact Lens Insertion	90	—
PRIMARY Subjective Dryness After Contact Lens Insertion	90	—
PRIMARY Subjective Rating of Clarity of Vision After Contact Lens Insertion	91	—
PRIMARY Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use	90	—
PRIMARY Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use	90	—
PRIMARY Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use	90	—
PRIMARY Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use	90	—
PRIMARY Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use	90	—
PRIMARY Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use	90	—
PRIMARY Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use	90	—
PRIMARY Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use	90	—
PRIMARY Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use	90	—
PRIMARY Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use	90	—
PRIMARY Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use	90	—
PRIMARY Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use	90	—
PRIMARY Subjective Comfort at End of Day With Contact Lens Wear	90	—
PRIMARY Subjective Dryness at End of Day With Contact Lens Wear	88	—
PRIMARY Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear	90	—
PRIMARY Subjective Comfort at End of Day With Contact Lens Wear	90	—
PRIMARY Subjective Dryness at End of Day With Contact Lens Wear	88	—
PRIMARY Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear	90	—
PRIMARY Subjective Comfort at End of Day With Contact Lens Wear	90	—
PRIMARY Subjective Dryness at End of Day With Contact Lens Wear	88	—
PRIMARY Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear	90	—
PRIMARY Subjective Comfort at End of Day With Contact Lens Wear	90	—
PRIMARY Subjective Dryness at End of Day With Contact Lens Wear	88	—
PRIMARY Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear	90	—

Eligibility Criteria

Inclusion Criteria

Is between 18 and 40 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;
Is a heavy digital device user (at least 6 hours on a typical day using any combination of digital devices such as PC, laptop, smartphone, or tablet);
Is a habitual wearer of daily, spherical, soft contact lenses (no bifocal or multifocal contact lenses, no extended wear or monovision, not a current wearer of Precision1 lenses) for at least 5 days/week and at least 10 hours/day during the month prior to enrollment;
Has a vertex corrected spherical equivalent distance refraction that ranges between -0.50D to -6.00D in each eye;
Has a vertex corrected refractive cylinder of no more than -1.00D cylindrical correction in each eye after vertexing to the corneal plane;
Demonstrates an acceptable fit and achieves best corrected visual acuity of at least 0.20 log MAR in each eye with Precision1 contact lenses;
Is willing to wear Precision1 CLs at least 5 days per week and 10 hours per day throughout the study;

Exclusion Criteria

Is participating in any concurrent clinical or research study;
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 pharmaceuticals to be used in the study;
Is pregnant, lactating or planning a pregnancy at the time of enrolment;
Is aphakic;
Has undergone refractive error surgery;
For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04201639). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.