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

Not Applicable

Completed

• Conditions: Refractive Errors
• Interventions: Device: LID021201 contact lenses; Device: OPTI-FREE multipurpose solution

• Registration Number: NCT04702984
• Lead Sponsor: Alcon Research

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2021-01-08
• Study First Submitted QC: 2021-01-08
• Study First Posted: 2021-01-11
• Study Start: 2021-01-21
• Primary Completion: 2021-02-26
• Study Completion: 2021-02-26
• Results First Submitted: 2022-02-10
• Results First Submitted QC: 2022-02-10
• Status Verified: 2022-03
• Results First Posted: 2022-03-08
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LID021201	OPTI-FREE multipurpose solution	LID021201 contact lenses worn in both eyes for 7 days. Lenses will be removed nightly for cleaning and disinfection with OPTI-FREE multipurpose solution.
LID021201	LID021201 contact lenses	LID021201 contact lenses worn in both eyes for 7 days. Lenses will be removed nightly for cleaning and disinfection with OPTI-FREE multipurpose solution.

Primary Outcome Measures

Name	Time	Method
Front Surface Wettability, by Category	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.

Trial Locations

Locations (3)

Alcon Investigator 6353; 🇺🇸 Memphis, Tennessee, United States

Alcon Investigator 6565; 🇺🇸 Maitland, Florida, United States

Alcon Investigator 8028; 🇺🇸 Wichita Falls, Texas, United States