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Completed

NCT Number: NCT04789382

Three Daily Wear Monthly Replacement Silicone Hydrogel Contact Lenses With Two Multi-purpose Disinfecting Solution Combinations

The purpose of this study is to evaluate corneal staining observed after 2 hours of wear with an investigational contact lens against both PureVision contact lenses pre-cycled with Biotrue and Biofinity contact lenses pre-cycled with RepleniSH.

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Key information

Conditions

Refractive Errors Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigator 6565

Maitland, Florida, 32751, United States

About this study

Subjects will be randomized in a 1:1:1:1 manner to receive one of 4 regimen sequences with lens and multipurpose disinfection solution (MPDS) combinations. The expected duration of subject participation in the study is approximately 1 week with 2 study visit days.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Understand and sign an Informed Consent;
  • Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
  • Manifest cylinder of less than or equal to 1.50 diopter (D) in each eye;
  • Best corrected visual acuity (BCVA) better than or equal to 20/25 Snellen in each eye;
  • Willing to stop wearing habitual contact lenses for the duration of study lens exposure and during the washout period.
  • Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

  • Any eye condition or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator;
  • Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
  • Eye surgery, as specified in the protocol;
  • Dry eye; use of artificial tears, as specified in the protocol;
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

LID018869+RepleniSH

Device

Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH)

LID018869+Biotrue

Device

Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue)

Biofinity+RepleniSH

Device

Comfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH)

PV+Biotrue

Device

Balafilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue)

Primary outcomes

  1. Average Percent Area of Corneal Staining

    Time frame: Hour 2 (each wear period)

    A slit lamp examination was performed by the investigator to assess corneal staining. Percent of solution-related corneal staining area was assessed first in each of the 5 corneal regions: central, superior, nasal, inferior, and temporal. The average of corneal staining area was then calculated as the average over all 5 regions. Each eye was treated differently and was graded separately. No hypotheses were formulated; no inferences were made, and only descriptive statistics were used in the reporting.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Clinical Biocompatibility of Three Daily Wear Monthly Replacement Silicone Hydrogel Contact Lenses With Two Multi-purpose Disinfecting Solution Combinations

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 9, 2021
Registry last updated
May 25, 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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