Pilot Clinical Performance of a Silicone Hydrogel Lens for Up to Six Nights of Extended Wear

Myopia Clinical Trial

Official title:

Pilot Clinical Performance of a Silicone Hydrogel Lens for Up to Six Nights of Extended Wear

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04403542
• Other study ID #: CLY935-C008
• Status: Completed
• Phase: N/A
• Start date: August 3, 2020
• Est. completion date: August 31, 2020

Study information

• Verified date: August 2023
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn continuously for up to 1 week.

Description:

Subjects will be randomized to wear the investigational contact lens in 1 eye and the commercially available contact lens in the other eye. Subjects will be expected to attend 3 scheduled study visits: Day 1 Screening/Baseline/Dispense; Day 2 Follow-up within 4 hours of awakening (after the first night of sleeping); and Week 1 Follow-up/Exit. The expected duration of exposure to each of the study lenses for all randomized, completed subjects was approximately 7 days / 6 nights of wear.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Able to understand and sign an IRB/IEC approved Informed Consent form.

• Successful wear of spherical soft contact lenses in both eyes during the past 3 months for a minimum of 5 days/week and in an extended wear modality at least 1 night/week.

• Best corrected visual acuity of 20/25 or better in each eye.

• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Any condition, use of medications, or surgery that could contraindicate contact lens wear, as determined by the Investigator.

• Any habitual wear of Biofinity contact lenses.

• Pregnant or breast-feeding.

• Other protocol specified exclusion criteria may apply.

Related Conditions & MeSH terms

• Hyperopia
• Myopia
• Refractive Errors

Intervention

Device:
• Lehfilcon A contact lens
Investigational silicone hydrogel contact lens
• Comfilcon A contact lens
Commercially available silicone hydrogel contact lens

Locations

Country	Name	City	State
United States	Alcon Investigator 8046	Granville	Ohio
United States	Alcon Investigator 6402	Medina	Minnesota
United States	Alcon Investigator 2786	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance Visual Acuity (VA) With Study Lenses	Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.	Day 1 Dispense; Day 2 Follow-up (within 4 hours of awakening); Week 1 Follow-up/Exit