NCT04464044

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

July 20, 2020

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2020

Completed
Last Updated

August 19, 2020

Status Verified

August 1, 2020

Enrollment Period

17 days

First QC Date

July 7, 2020

Last Update Submit

August 18, 2020

Conditions

Astigmatism

Keywords

Toric contact lensDaily disposableSilicone hydrogel contact lensAxis orientationAstigmatism

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

DDT2 Toric

EXPERIMENTAL

Verofilcon A toric contact lenses worn in both eyes

Device: verofilcon A toric contact lenses

Interventions

verofilcon A toric contact lensesDEVICE

Daily disposable toric soft contact lenses

Also known as: DDT2 Toric
DDT2 Toric

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Clinical Trial Lead, Vision Care

    Alcon Research, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2020

First Posted

July 9, 2020

Study Start

July 20, 2020

Primary Completion

August 6, 2020

Study Completion

August 6, 2020

Last Updated

August 19, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)