Clinical Performance of a Daily Disposable Toric Silicone Hydrogel Contact Lens

Astigmatism Clinical Trial

Official title:

Clinical Performance of a Daily Disposable Toric Silicone Hydrogel Contact Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04464044
• Other study ID #: CLA306-C003
• Status: Completed
• Phase: N/A
• Start date: July 20, 2020
• Est. completion date: August 6, 2020

Study information

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

Clinical Trial Summary

The purpose of this study is to obtain on-eye clinical performance data to evaluate the stability of axis orientation of DDT2 toric contact lenses in the intended population.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 6, 2020
• Est. primary completion date: August 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to understand and sign an informed consent form;

• Successful wear of spherical or toric soft contact lenses in both eyes, as specified in the protocol;

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

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Any eye condition that would contraindicate contact lens wear, as determined by the Investigator;

• History of eye surgery within the previous 12 months, as specified in the protocol;

• Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;

• Other protocol-specified exclusion criteria may apply.

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• verofilcon A toric contact lenses
Daily disposable toric soft contact lenses

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

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 lenses with axis orientation within ±30° from the intended axis, 10 minutes after lens insertion	Axis orientation (orientation of the scribe mark) will be assessed by slit lamp examination and recorded as deviations from intended axis.	Day 1, 10 minutes after lens insertion