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OpenTrials
Completed

NCT Number: NCT04702984

Clinical Characterization of an Investigational Frequent Replacement Daily Wear Silicone Hydrogel Sphere Contact Lens

The primary objective of this study is to evaluate the overall clinical performance of an investigational silicone hydrogel contact lens over 7 days of daily wear.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigator 6565, Maitland, Florida, United States

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About this study

Participants will attend a Screening visit, a Dispense visit, and a Week 1 Follow-up/exit visit.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Understand and sign an Informed Consent that has been approved by an Institutional Review Board.
  • Successful wear of spherical daily wear frequent replacement soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
  • Willing to stop wearing habitual contact lenses for the duration of study participation.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Any condition that contraindicates contact lens wear, as determined by the Investigator.
  • Any use of systemic or ocular medications that contraindicates contact lens wear, as determined by the Investigator.
  • History of refractive surgery or plan to have refractive surgery during the study.
  • Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear.
  • Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

LID021201 contact lenses

Device

Investigational silicone hydrogel sphere contact lenses for frequent replacement daily wear

OPTI-FREE multipurpose solution

Device

Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses

Other names: OPTI-FREE® RepleniSH®

Primary outcomes

  1. Front Surface Wettability, by Category

    Time frame: Dispense; Week 1 Follow-up

    Front surface wettability (i.e., assessment of the disruption of the front surface wettability of the contact lens) was assessed by the investigator for each eye individually. Front surface wettability was collected on a 5-point scale, where where Grade 0 = a smooth uniformly reflecting surface, Grade 1 = a coarse hazy surface which seems resolved momentarily with each blink and becomes exacerbated with staring, Grade 2 = one stable dry (non-wetting) area of some magnitude, Grade 3 = more than one stable dry (non-wetting) area of some magnitude, and Grade 4 = non-wettable lens surface. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 11, 2021
Registry last updated
Mar 16, 2022

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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