NCT02920983

Brief Summary

This study aims to compare the clinical performance of the somfilcon A, nelfilcon A II 2 and omafilcon A II 2 daily disposable contact lenses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

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

Study Start

First participant enrolled

September 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

June 26, 2019

Completed
Last Updated

October 17, 2019

Status Verified

October 1, 2019

Enrollment Period

2 months

First QC Date

September 29, 2016

Results QC Date

October 17, 2017

Last Update Submit

October 15, 2019

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • Ocular Physiology

    Ocular physiology assessment of by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

    1 week

Secondary Outcomes (7)

  • Lens Fit - Horizontal Centration

    1 week

  • Lens Fit - Vertical Centration

    1 week

  • Lens Fit - Corneal Coverage

    1 week

  • Lens Fit - Movement

    1 week

  • Lens Surface - Deposition

    1 week

  • +2 more secondary outcomes

Study Arms (3)

somofilcon A

ACTIVE COMPARATOR

Subjects are randomized to wear somofilcon A for one week during the cross over study.

Device: somofilcon A

nelfilcon A II 2

ACTIVE COMPARATOR

Subjects are randomized to wear nelfilcon A II 2 for one week during the cross over study.

Device: nelfilcon A II 2

omafilcon A ll 2

ACTIVE COMPARATOR

Subjects are randomized to wear omafilcon A ll 2 for one week during the cross over study.

Device: omafilcon A ll 2

Interventions

somofilcon ADEVICE

contact lens

somofilcon A
nelfilcon A II 2DEVICE

contact lens

nelfilcon A II 2
omafilcon A ll 2DEVICE

contact lens

omafilcon A ll 2

Eligibility Criteria

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

You may qualify if:

  • Subjects will only be eligible for the study if:
  • They are of legal age (18) and capacity to volunteer.
  • They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
  • They are willing and able to follow the protocol.
  • They agree not to participate in other clinical research for the duration of this study.
  • They have a contact lens spherical prescription between -1.00 to - 6.00D (Diopters) (inclusive)
  • They have a spectacle cylindrical correction of -0.75D or less in each eye.
  • At dispensing, they can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
  • They currently use soft contact lenses or have done so in the previous six months.
  • They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).

You may not qualify if:

  • Subjects will not be eligible to take part in the study if:
  • They have an ocular disorder which would normally contra-indicate contact lens wear.
  • They have a systemic disorder which would normally contra-indicate contact lens wear.
  • They are using any topical medication such as eye drops or ointment.
  • They have had cataract surgery.
  • They have had corneal refractive surgery.
  • They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
  • They are pregnant or breast-feeding.
  • They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
  • They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
  • They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eurolens Research - The University of Manchester

Manchester, M13 9PL, United Kingdom

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Jose Vega, O.D., MSc., FAAO
Organization
CooperVision Inc.
jvega2@coopervision.com
9256213761

Study Officials

  • Carole Maldonado-Codinal, PhD, FAAO

    Eurolens Research, University of Manchester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

September 29, 2016

First Posted

September 30, 2016

Study Start

September 1, 2016

Primary Completion

November 1, 2016

Study Completion

February 1, 2017

Last Updated

October 17, 2019

Results First Posted

June 26, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)