Clinical Characterization of an Investigational Soft Silicone Hydrogel Contact Lens

Refractive Errors Clinical Trial

Official title:

Clinical Characterization of an Investigational Soft Silicone Hydrogel Contact Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04631796
• Other study ID #: CLY935-E006
• Status: Completed
• Phase: N/A
• Start date: December 3, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2021
• 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 2 weeks of daily wear.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• 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 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.

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• Lehfilcon A contact lenses
Silicone hydrogel contact lenses with investigational coating
• Multipurpose disinfection solution
Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses

Locations

Country	Name	City	State
United States	Alcon Investigative Site	Bloomington	Illinois
United States	Alcon Investigative Site	Orlando	Florida
United States	Alcon Investigative Site	Powell	Ohio

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 and Grade 4 = non-wettable lens surface. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed.	Dispense; Week 2 Follow-up