Assessing the Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Toric Contact Lenses

Not Applicable

Completed

• Conditions: Astigmatism; Refractive Errors; Presbyopia

• Registration Number: NCT05886907
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this clinical trial is to assess on-eye performance and overall fit of an investigational multifocal toric contact lens to aid in confirmation of the study lens design.

Detailed Description

Subjects will attend 3 study visits with a planned individual duration of participation of up to 10 days.

Study Timeline

• Study First Submitted: 2023-05-24
• Study First Submitted QC: 2023-05-24
• Study First Posted: 2023-06-02
• Study Start: 2023-06-14
• Primary Completion: 2023-07-17
• Study Completion: 2023-07-17
• Status Verified: 2024-07
• Results First Submitted: 2024-07-08
• Results First Submitted QC: 2024-07-08
• Last Update Submitted: 2024-07-08
• Results First Posted: 2024-07-31
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Requires ADD (additional power for near vision);
• Currently wears multifocal soft contact lenses in both eyes during the past 3 months;
• Manifest cylinder power between -0.75 diopter (D) and -1.00 D;
• Best Corrected Visual Acuity (BCVA) of logMAR 0.10 (Snellen 20/25) or better in each eye.
• Other protocol-specified inclusion criteria may apply.

Key

Exclusion Criteria

• Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator;
• Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
• Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
• Monovision contact lens wear.
• Other protocol-specified exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Mean Distance Visual Acuity (VA) With Study Lenses	Day 2, each wear period. A wear period was approximately 2 days.	Visual Acuity (VA) was assessed binocularly (both eyes together) with study lenses in place at a distance of 4 meters using letter charts. VA was recorded in logarithm minimum angle of resolution (logMAR), where 0.0 logMAR equates to 20/20 Snellen (normal distance eyesight). A lower number indicates better visual acuity. No hypothesis testing is pre-specified for this endpoint.

Trial Locations

Locations (1)

Johns Creek Research Clinic; 🇺🇸 Johns Creek, Georgia, United States