NCT04831515

Brief Summary

The objective of the study is to compare the clinical performance of two different daily disposable, SiHy toric contact lens types, Lens A and Lens B, in existing soft lens wearers when worn for one week each.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

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

Study Start

First participant enrolled

March 29, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2021

Completed
7 months until next milestone

Results Posted

Study results publicly available

February 11, 2022

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

3 months

First QC Date

April 1, 2021

Results QC Date

January 20, 2022

Last Update Submit

February 11, 2022

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (1)

  • Overall Ease of Lens Handling

    Ease of overall lens handling for putting on eyes, removing from eyes, and opening packaging will be measured on a 0-10 integer scale (0=Very difficult, 10-Very easy)

    1 week

Secondary Outcomes (2)

  • Visual Acuity

    Baseline - after lenses have settled for 10 minutes

  • Visual Acuity

    1 week

Study Arms (2)

Lens A

EXPERIMENTAL

daily disposable soft contact lens - test lens Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week.

Device: Lens ADevice: Lens B

Lens B

ACTIVE COMPARATOR

daily disposable soft contact lens - control lens Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week.

Device: Lens ADevice: Lens B

Interventions

Lens ADEVICE

daily disposable soft contact lens - test lens

Lens ALens B
Lens BDEVICE

daily disposable soft contact lens - control lens

Lens ALens B

Eligibility Criteria

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

You may qualify if:

  • Is at least 18 years of age and has full legal capacity to volunteer;
  • Has read and signed an information consent letter;
  • Self reports having a full eye examination in the previous two years;
  • Anticipates being able to wear the study lenses for at least 12 hours a day, 7 days a week;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Habitually wears toric soft contact lenses binocularly, of any replacement frequency, for the past 3 months minimum;
  • Has refractive astigmatism at least -0.75DC in each eye, maximum -2.25DC;
  • Has refractive cylinder axis either between 155 to 25 or between 65 and 115 degrees;
  • Is myopic and requires a spectacle spherical component of -1.00D to -6.50D inclusively;
  • Can be fit and achieve binocular distance vision of at least 20/30 Snellen with the available lens parameters

You may not qualify if:

  • Is participating in any concurrent clinical or research study;
  • Habitually wears one of the study contact lenses;
  • Has any known active ocular disease and/or infection that contraindicates contact lens wear;
  • Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  • Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
  • Has known sensitivity to the diagnostic sodium fluorescein used in the study;
  • Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
  • Has undergone refractive error surgery or intraocular surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Golden Optometric Group

Whittier, California, 90606, United States

Location

Golden Vision

Sarasota, Florida, 34237, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

Athens Eye Care

Athens, Ohio, 45701, United States

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Jose A. Vega, O.D., MSc, FAAO
Organization
Coopervision
JVega2@coopervision.com
9256213761

Study Officials

  • Lyndon Jones, PhD, FCOptom

    Centre for Ocular Research and Education

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

April 1, 2021

First Posted

April 5, 2021

Study Start

March 29, 2021

Primary Completion

July 2, 2021

Study Completion

July 2, 2021

Last Updated

February 15, 2022

Results First Posted

February 11, 2022

Record last verified: 2022-02

Locations

US(4)