Clinical Performance of a Silicone Hydrogel Contact Lens Following Six Nights of Extended Wear

Refractive Errors Clinical Trial

Official title:

Clinical Performance of a Silicone Hydrogel Following Six Nights of Extended Wear

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03614130
• Other study ID #: CLL949-C005
• Status: Completed
• Phase: N/A
• Start date: August 23, 2018
• Est. completion date: September 11, 2018

Study information

• Verified date: September 2021
• 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 following 1 week of extended wear.

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 Baseline/Dispense; Day 2 Follow-up; 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: 22
• Est. completion date: September 11, 2018
• Est. primary completion date: September 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Able to understand and sign an Institutional Review Board/Ethics Committee-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 per week and in an extended wear modality a minimum of 1 night per week.

• Best Corrected Visual Acuity (BCVA) 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.

• Current Biofinity© lens wearer.

• Pregnant or breast-feeding.

• Other protocol-specified exclusion criteria may apply.

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• LID011121 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 Investigative Site	Brentwood	Tennessee
United States	Alcon Investigative Site	Johns Creek	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity (VA) With Study Lenses, Collected by Eye	Visual acuity (VA) was assessed for each eye individually with study lenses in place 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 (ideally within 4 hours of awakening); Week 1 Follow-up/Exit