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

Clinical Biocompatibility of 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.

Study Overview

• Status: Completed
• Conditions: Refractive Errors
• Intervention / Treatment: Device: LID018869+RepleniSH; Device: LID018869+Biotrue; Device: Biofinity+RepleniSH; Device: PV+Biotrue

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Maitland, Florida, United States, 32751
      • Alcon Investigator 6565

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Sequence 1; LID018869+RepleniSH in the right eye and Biofinity+RepleniSH in the left eye (first wear period), followed by PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (second wear period). Each wear period will be 2 hours.	Device: LID018869+RepleniSH; Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH); Device: LID018869+Biotrue; Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue); Device: Biofinity+RepleniSH; Comfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH); Device: PV+Biotrue; Balafilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue)
Other: Sequence 2; Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (first wear period), followed by LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (second wear period). Each wear period will be 2 hours.	Device: LID018869+RepleniSH; Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH); Device: LID018869+Biotrue; Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue); Device: Biofinity+RepleniSH; Comfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH); Device: PV+Biotrue; Balafilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue)
Other: Sequence 3; LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (first wear period), followed by Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (second wear period). Each wear period will be 2 hours.	Device: LID018869+RepleniSH; Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH); Device: LID018869+Biotrue; Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue); Device: Biofinity+RepleniSH; Comfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH); Device: PV+Biotrue; Balafilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue)
Other: Sequence 4; PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (first wear period), followed by LID018869+RepleniSH in the right eye and Biofinity+RepleniSH the left eye (second wear period). Each wear period will be 2 hours.	Device: LID018869+RepleniSH; Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH); Device: LID018869+Biotrue; Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue); Device: Biofinity+RepleniSH; Comfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH); Device: PV+Biotrue; Balafilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Percent Area of Corneal Staining	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.	Hour 2 (each wear period)

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2021
• Primary Completion (Actual): May 7, 2021
• Study Completion (Actual): May 7, 2021

Study Registration Dates

• First Submitted: March 5, 2021
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: contact lens; contact lens solution
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLY935-E007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No