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

Alcon

Status: Completed

Conditions: Refractive Errors

Treatments: Device: AO1DfA contact lenses; Device: DT1 Toric contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT04254003

CLO870-C003

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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48 participants in 2 patient groups

Test, then Control

Other group

Description:

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.

Treatment:

Device: DT1 Toric contact lenses

Device: AO1DfA contact lenses

Control, then Test

Other group

Description:

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.

Treatment:

Device: DT1 Toric contact lenses

Device: AO1DfA contact lenses