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OpenTrials
Completed

NCT Number: NCT03459131

Clinical Evaluation of Two Monthly Contact Lenses

The purpose of this study is to explore overall vision with BIOFINITY® ENERGYS™ contact lenses as compared to BIOFINITY® contact lenses after one week of wear.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigative Site

Maitland, Florida, 32751, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to understand and sign an approved informed consent form (ICF);
  • Successful wear of BIOFINITY® (spherical) (or private label) contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
  • Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
  • Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes (OU) and be willing to wear them (as needed);
  • Currently using digital devices (computer, tablet, and/or smart phone) for a minimum of 5 days per week and 4 hours per day;
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Any anterior segment infection, inflammation, abnormality or disease that contraindicates contact lens wear;
  • Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
  • Refractive, ocular, or intraocular surgery, as specified in the protocol;
  • Current or history of eye injury or disorders, as specified in the protocol;
  • Current or history of intolerance, hypersensitivity or allergy to any component of the study products;
  • Habitual contact lens wear in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
  • Use of topical ocular medications that would require instillation during contact lens wear;
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

Comfilcon A with Digital Zone Optics™ contact lenses

Device

Silicone hydrogel spherical contact lenses with Digital Zone Optics™

Other names: BIOFINITY® ENERGYS™

Comfilcon A contact lenses

Device

Silicone hydrogel spherical contact lenses

Other names: BIOFINITY®

Primary outcomes

  1. Subjective Rating of Overall Vision

    Time frame: Day 7, each product

    Overall vision was assessed binocularly (both eyes together) by the subject on a 10-point scale, where 1=poor and 10=excellent. Inferential testing was not planned for this primary effectiveness endpoint.

Secondary outcomes

  1. Over-refraction

    Time frame: Day 1 (Dispense), each product

    Over-refraction (amount of additional correction needed to improve visual acuity (VA)) was collected for each eye and measured in diopters (D). Inferential testing was not planned for this endpoint.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 8, 2018
Registry last updated
Mar 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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