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

Refractive Errors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04254003
• Other study ID #: CLO870-C003
• Status: Completed
• Phase: N/A
• Start date: February 5, 2020
• Est. completion date: March 2, 2020

Study information

• Verified date: March 2020
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 2, 2020
• Est. primary completion date: March 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• DT1 Toric contact lenses
Delefilcon A contact lenses for the optical correction of astigmatism in people with healthy eyes with or without refractive ametropia (myopia or hyperopia)
• AO1DfA contact lenses
Senofilcon A contact lenses for the optical correction of astigmatism in people with healthy eyes with or without refractive ametropia (myopia or hyperopia)

Locations

Country	Name	City	State
United States	Alcon Investigative Site CT-27	Eden Prairie	Minnesota
United States	Alcon Investigative Site CT-11	Maitland	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

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