Clinical Performance Evaluation of Two Daily Disposable Silicone Hydrogel Toric Contact Lenses

Not Applicable

Completed

• Conditions: Refractive Errors
• Interventions: Device: DT1 Toric contact lenses; Device: AO1DfA contact lenses

• Registration Number: NCT04254003
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to evaluate the rotational behavior of DT1 Toric contact lenses.

Detailed Description

This is a single visit, non-dispense study where subjects will be exposed to the test and control lenses for approximately 1 hour each.

Study Timeline

• Study First Submitted: 2020-01-31
• Study First Submitted QC: 2020-02-03
• Study Start: 2020-02-05
• Study First Posted: 2020-02-05
• Status Verified: 2020-03
• Primary Completion: 2020-03-02
• Study Completion: 2020-03-02
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Current wearer of any commercial soft daily wear contact lens with at least 3 months of wearing experience with a minimum wearing time of 5 days per week and 8 hours per day.
• Requiring contact lens (manifest refraction) of a cylindrical power of -0.75 to -2.50 diopter cylinder (DC).
• Best corrected distance visual acuity 20/25 or better Snellen in each eye (as determined by manifest refraction at screening).
• Willing to NOT use rewetting/lubricating drops at any time during the study. Other protocol-defined inclusion criteria may apply.

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.
• History of refractive surgery or plan to have refractive surgery during the study or irregular cornea in either eye.
• Eye injury in either eye within 12 weeks immediately prior to enrollment for this trial.

Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control, then Test	DT1 Toric contact lenses	AO1DfA contact lenses worn first, followed by DT1 Toric contact lenses, as randomized. Each product will be worn in both eyes for approximately 1 hour.
Test, then Control	AO1DfA contact lenses	DT1 Toric contact lenses worn first, followed by AO1DfA contact lenses, as randomized. Each product will be worn in both eyes for approximately 1 hour.
Control, then Test	AO1DfA contact lenses	AO1DfA contact lenses worn first, followed by DT1 Toric contact lenses, as randomized. Each product will be worn in both eyes for approximately 1 hour.
Test, then Control	DT1 Toric contact lenses	DT1 Toric contact lenses worn first, followed by AO1DfA contact lenses, as randomized. Each product will be worn in both eyes for approximately 1 hour.

Primary Outcome Measures

Name	Time	Method
Percent of DT1 toric lenses with axis orientation within ±30° from the intended axis, 10 min after lens insertion	Day 1, 10 minutes after lens insertion, each product	A slit lamp will be used to observe axis orientation.

Trial Locations

Locations (2)

Alcon Investigative Site CT-27; 🇺🇸 Eden Prairie, Minnesota, United States

Alcon Investigative Site CT-11; 🇺🇸 Maitland, Florida, United States