NCT03518008

Brief Summary

The purpose of this study is to evaluate the overall performance of investigational contact lenses (DD T2) when compared to clariti® 1 day contact lenses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 8, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

May 23, 2018

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2018

Completed
10 months until next milestone

Results Posted

Study results publicly available

April 3, 2019

Completed
Last Updated

April 3, 2019

Status Verified

March 1, 2019

Enrollment Period

19 days

First QC Date

May 1, 2018

Results QC Date

March 14, 2019

Last Update Submit

March 14, 2019

Conditions

MyopiaRefractive Errors

Keywords

soft contact lensesvisioneyesight

Outcome Measures

Primary Outcomes (1)

  • Overall Quality of Vision

    Overall quality of vision was measured as a subjective rating, collected binocularly on a scale of 1 (Poor) to 10 (Excellent). No inferences were made; therefore, no hypotheses were formulated.

    Day 8, each product

Study Arms (2)

DD T2, then Clariti 1 Day

OTHER

Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable modality.

Device: verofilcon A contact lensesDevice: somofilcon A contact lenses

Clariti 1 Day, then DD T2

OTHER

Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second. Each product worn bilaterally for 1 week in a daily disposable modality.

Device: verofilcon A contact lensesDevice: somofilcon A contact lenses

Interventions

verofilcon A contact lensesDEVICE

Investigational daily disposable soft contact lenses

Also known as: DD T2
Clariti 1 Day, then DD T2DD T2, then Clariti 1 Day
somofilcon A contact lensesDEVICE

Commercially available daily disposable soft contact lenses

Also known as: clariti® 1 day, Clariti 1 Day
Clariti 1 Day, then DD T2DD T2, then Clariti 1 Day

Eligibility Criteria

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

You may qualify if:

  • Understand and sign an Informed Consent Form;
  • Successful wear of daily disposable spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
  • Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
  • Willing to stop wearing habitual contact lenses for the duration of study participation;

You may not qualify if:

  • Anterior segment infection, inflammation, or abnormality or disease that contraindicates contact lens wear, as determined by the Investigator;
  • Use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
  • Refractive, ocular, or intraocular surgery, as specified in the protocol;
  • Eye condition or injury, as specified in the protocol;
  • Current or history of intolerance, hypersensitivity, or allergy to any component of the study products;
  • Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
  • Use of topical ocular medications and artificial tear or rewetting drops requiring instillation during contact lens wear;
  • Currently wearing clariti® 1 day contact lenses;
  • Habitually wearing monovision or multifocal lenses during the last 3 months;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alcon Investigative Site

Maitland, Florida, 32751, United States

Location

MeSH Terms

Conditions

MyopiaRefractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

Title
Senior Clinical Project Lead, GCRA - Vision Care
Organization
Alcon Research
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Alcon Research

    Alcon Research

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2018

First Posted

May 8, 2018

Study Start

May 23, 2018

Primary Completion

June 11, 2018

Study Completion

June 11, 2018

Last Updated

April 3, 2019

Results First Posted

April 3, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)