NCT03951610

Brief Summary

The purpose of this study is to compare the dispensing performance of somofilcon A test 1 day contact lens against somofilcon A control 1 day contact lens.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 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

February 21, 2019

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2019

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 15, 2019

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2019

Completed
1 year until next milestone

Results Posted

Study results publicly available

June 18, 2020

Completed
Last Updated

June 18, 2020

Status Verified

May 1, 2020

Enrollment Period

1 month

First QC Date

March 11, 2019

Results QC Date

May 15, 2020

Last Update Submit

June 5, 2020

Conditions

Myopia

Outcome Measures

Primary Outcomes (14)

  • Number of Participants With Lens Centration

    Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (\<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (\>0.5mm N T S I)

    Baseline

  • Number of Participants With Lens Centration

    Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (\<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (\>0.5mm N T S I)

    1 week

  • Post Blink Movement

    Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink)

    Baseline

  • Post Blink Movement

    Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink)

    1 week

  • Primary Gaze Lag

    Primary Gaze Lag (measured in mm at 0.1mm steps)

    baseline

  • Primary Gaze Lag

    Primary Gaze Lag (measured in mm at 0.1mm steps)

    1 week

  • Up Gaze Lag

    Up Gaze Lag (measured in mm at 0.1mm steps)

    Baseline

  • Up Gaze Lag

    Up Gaze Lag (measured in mm at 0.1mm steps)

    1 week

  • Push-Up Tightness

    Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement)

    baseline

  • Push-Up Tightness

    Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement)

    1 week

  • Overall Fit Acceptance

    Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum

    Baseline

  • Overall Fit Acceptance

    Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum

    1 week

  • Number of Participants With Overall Lens Fit Impression

    Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable

    Baseline

  • Number of Participants With Overall Lens Fit Impression

    Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable

    1 week

Secondary Outcomes (2)

  • Subjective Comfort Rating

    Baseline

  • Subjective Comfort Rating

    1-week

Study Arms (2)

Test lens

EXPERIMENTAL

Subjects wearing the test lens for one week, either randomized as the first or second pair.

Device: Test lensDevice: Control lens

Control lens

ACTIVE COMPARATOR

Subjects wearing the control lens for one week, either randomized as the first or second pair.

Device: Test lensDevice: Control lens

Interventions

Test lensDEVICE

contact lens

Also known as: Invigor I DD lens, Somofilcon A 1 day Test
Control lensTest lens
Control lensDEVICE

contact lens

Also known as: Clariti 1-day, Somofilcon A 1 day control
Control lensTest lens

Eligibility Criteria

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

You may qualify if:

  • Has had a self-reported oculo-visual examination in the last two years.
  • Is at least 18 years of age and has full legal capacity to volunteer.
  • Has read and understood the information consent letter.
  • Is willing and able to follow instructions and maintain the appointment schedule.
  • Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
  • Currently wears soft contact lenses (average wearing of 8 hours/day and 5 days/week) without the need of using rewetting drops
  • Requires spectacle lens spherical powers between -1.00 to -5.75 diopters sphere (0.25D steps).
  • Has no more than 0.75 diopters of refractive astigmatism.
  • Has clear corneas and no active ocular disease.
  • Has not worn lenses for at least 12 hours before the examination.
  • Has a usable pair of spectacle lenses if required for transportation to the site for the initial visit

You may not qualify if:

  • Is presently participating in any other clinical or research study including eye related clinical or research study.
  • Has never worn contact lenses before.
  • Has any systemic disease affecting ocular health.
  • Has any active ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
  • Is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health.
  • Has any known sensitivity to fluorescein dye or products to be used in the study.
  • Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
  • Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
  • Is aphakic.
  • Has undergone corneal refractive surgery.
  • Is pregnant, lactating, or planning a pregnancy at the time of enrollment (by verbal confirmation at the screening visit).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Eye Center at Ketchum Health

Anaheim, California, 92807, United States

Location

Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University

Bloomington, Indiana, 47405, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Myhanh Nguyen
Organization
CooperVision, Inc.
mnguyen@coopervision.com
925-730-6716

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
Masking Details
Double (participant and investigator)
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: This will be a, prospective, double-masked, randomized, bilateral, 1 week cross-over, dispensing study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2019

First Posted

May 15, 2019

Study Start

February 21, 2019

Primary Completion

April 5, 2019

Study Completion

June 4, 2019

Last Updated

June 18, 2020

Results First Posted

June 18, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)