Clinical Assessment of Two Daily Wear Reusable Soft Silicone Hydrogel Contact Lenses

Refractive Errors Clinical Trial

Official title:

Clinical Assessment of Two Daily Wear Reusable Soft Silicone Hydrogel Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05056987
• Other study ID #: CLY935-C018
• Status: Completed
• Phase: N/A
• Start date: January 12, 2022
• Est. completion date: June 14, 2022

Study information

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

Clinical Trial Summary

The overall objective of this clinical study is to describe the clinical performance of the TOTAL30® soft contact lens compared to the ACUVUE® OASYS® with HYDRACLEAR PLUS (AOHP) soft contact lens in a daily wear modality.

Description:

Subjects will be expected to attend 3 visits and wear the study contact lenses at least 5 days per week and at least 8 hours per day. On Visits 2 and 3, subjects will be expected to wear the study lenses at least 6 hours prior to the study visit. The expected total duration of subject participation in the study will be approximately 1.5 months. This study will be conducted in the United Kingdom (UK).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 14, 2022
• Est. primary completion date: June 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Currently wearing any commercial spherical soft contact lenses with at least 3 months wearing experience.

• Willing to wear the study lenses for a minimum of 5 days per week and 8 hours per day.

• Willing to NOT use rewetting/lubricating drops at any time during the study.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Participation in a clinical trial within the previous 14 days or currently enrolled in any clinical trial.

• Habitual AOHP contact lens wearers (in the past 3 months).

• Monovision wear during the study.

• Other protocol-defined exclusion criteria may apply.

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• Lehfilcon A contact lenses
CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use
• Senofilcon A contact lenses
CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use
• AOSEPT PLUS with HydraGlyde
Hydrogen peroxide-based cleaning and disinfecting solution

Locations

Country	Name	City	State
United Kingdom	Eurolens Research	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance VA (logMAR) With Study Lenses	Distance visual acuity (VA) was assessed for each eye individually with study lenses in place using letter charts. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. The follow-up visit for TOTAL 30 occurred approximately 28 days after the baseline visit. The follow-up visit for AOHP occurred approximately 14 days after the baseline visit. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.	Dispense (Day 0) and Follow-Up (Day 28 for TOTAL30, Day 14 for AOHP) (each wear period)