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

Refractive Errors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04702984
• Other study ID #: CLL949-E003
• Status: Completed
• Phase: N/A
• Start date: January 21, 2021
• Est. completion date: February 26, 2021

Study information

• Verified date: March 2022
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: February 26, 2021
• Est. primary completion date: February 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• LID021201 contact lenses
Investigational silicone hydrogel sphere contact lenses for frequent replacement daily wear
• OPTI-FREE multipurpose solution
Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses

Locations

Country	Name	City	State
United States	Alcon Investigator 6565	Maitland	Florida
United States	Alcon Investigator 6353	Memphis	Tennessee
United States	Alcon Investigator 8028	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Front Surface Wettability, by Category	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.	Dispense; Week 1 Follow-up