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Clinical Trials/NCT04528017
NCT04528017
Completed
Not Applicable

Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 2

Alcon Research4 sites in 1 country56 target enrollmentSeptember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Refractive Errors
Sponsor
Alcon Research
Enrollment
56
Locations
4
Primary Endpoint
Distance Visual Acuity (VA) With Study Lenses
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The primary objective of this study is to evaluate the overall performance of PRECISION1 contact lenses when compared to Clariti 1-Day contact lenses.

Detailed Description

Subjects are expected to attend 3 study visits and wear the PRECISION1 and Clariti 1-Day study lenses in a crossover design for approximately 8 days of exposure to each study lens type. The expected duration of subject participation is up to 22 days.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
October 16, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Any ocular condition that contraindicates contact lens wear.
  • Previous or current habitual wearer of PRECISION1, Clariti 1-Day, or DAILIES TOTAL1 contact lenses.
  • Other protocol-specified exclusion criteria may apply.

Outcomes

Primary Outcomes

Distance Visual Acuity (VA) With Study Lenses

Time Frame: Day 8 (-0/+3 days) after 10 (-2/+6) hours of wear, each study lens type

Distance VA was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed.

Study Sites (4)

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