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OpenTrials
Completed

NCT Number: NCT04631796

Clinical Characterization of an Investigational Soft Silicone Hydrogel Contact Lens

The primary objective of this study is to evaluate the overall clinical performance of an investigational silicone hydrogel contact lens over 2 weeks 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 Investigative Site, Orlando, Florida, United States

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About this study

Participants will attend a Screening visit, a Dispense visit (0 to 4 days later), and a follow-up visit approximately 2 weeks after the Dispense 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 weekly/monthly 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.
  • Habitual contact lenses worn in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
  • Any use of topical ocular medications or artificial tear or rewetting drops that would require instillation during contact lens wear.
  • Monovision or multifocal contact lens wear.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Lehfilcon A contact lenses

Device

Silicone hydrogel contact lenses with investigational coating

Other names: LID020098

Multipurpose disinfection 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 2 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 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
2020
Primary completion
2020
Study completion
2020
First posted
Nov 17, 2020
Registry last updated
Jan 12, 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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