NCT02510820

Brief Summary

This will be a controlled and randomized, single-masked, crossover study in which 48 subjects will use the Biofinity Contact Lens (comfilcon A) with each of the two lens care products ('solutions'), (Synergi and Biotrue Multi-purpose Solution) for one month each. Follow-up visits for each solution will take place at one week, two weeks and four weeks: with a one-week 'wash-out' period between the solutions. Key outcome measures for this study include biomicroscopic and subjective responses to the lens/solution combinations.

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 May 2015

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

May 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 29, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

February 1, 2017

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

4 months

First QC Date

July 16, 2015

Results QC Date

January 30, 2017

Last Update Submit

January 30, 2017

Conditions

Myopia

Outcome Measures

Primary Outcomes (17)

  • Conjunctival Hyperaemia

    Conjunctival hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.

    Baseline, 1 week, 2 weeks, 4 weeks

  • Limbal Hyperaemia

    Limbal hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.

    Baseline, 1 week, 2 weeks, 4 weeks

  • Corneal Staining

    Corneal staining of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=none, 4=patch.

    Baseline, 1 week, 2 weeks, 4 weeks

  • Papillary Conjunctivitis

    Papillary conjunctivitis of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.

    Baseline, 1 week, 2 weeks, 4 weeks

  • Comfort

    Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 1 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.

    1 week

  • Comfort

    Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 2 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.

    2 weeks

  • Comfort

    Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 4 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.

    4 weeks

  • Vision

    Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.

    1 week

  • Vision

    Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 2 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.

    2 weeks

  • Vision

    Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 4 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.

    4 weeks

  • Dryness

    Subjective assessment of dryness for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=extremely dry 100=not dry at all.

    1 week, 2 weeks, 4 weeks

  • Burning/Stinging

    Subjective assessment of burning/stinging for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=Extreme stinging / burning, 100=No stinging / burning sensation.

    1 week, 2 weeks, 4 weeks

  • Ocular Redness

    Subjective ocular redness of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=extremely poor. intolerable levels of redness, 100=excellent, no redness.

    1 week, 2 weeks, 4 weeks

  • Ease of Lens Insertion

    Subjective assessment of insertionfor Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to insert, 100=excellent. no problem with lens insertion.

    1 week, 2 weeks, 4 weeks

  • Ease of Lens Removal

    Subjective assessment of removal for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to remove, 100=excellent. no problem with lens remove.

    1 week, 2 weeks, 4 weeks

  • Ease of Use of Solution

    Subjective ease of use for Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=very difficult, 100=very easy

    1 week, 2 weeks, 4 weeks

  • Overall Score

    Subjective overall scores Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=extremely poor, 100=excellent, highly impressed.

    1 week, 2 weeks, 4 weeks

Study Arms (2)

Synergi / comfilcon A

ACTIVE COMPARATOR

Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.

Device: comfilcon ADevice: SynergiOther: stenfilcon A

Biotrue / comfilcon A

ACTIVE COMPARATOR

Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.

Device: comfilcon ADevice: BiotrueOther: stenfilcon A

Interventions

comfilcon ADEVICE

soft contact lens

Also known as: Biofinity
Biotrue / comfilcon ASynergi / comfilcon A
SynergiDEVICE

Multipurpose solution

Synergi / comfilcon A
BiotrueDEVICE

Multipurpose solution

Biotrue / comfilcon A
stenfilcon AOTHER

daily disposable contact lenses for washout period

Biotrue / comfilcon ASynergi / comfilcon A

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • They are of legal age 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 - 0.50 to - 6.00 (inclusive)
  • They have a spectacle cylindrical correction of -1.00D (Diopters) 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 silicone hydrogel soft contact lenses.
  • They are willing to comply with the wear schedule (at least 5 days per week, ≥8 hours/day).

You may not qualify 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 lactating.
  • 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

Manchester, M13 9PL, United Kingdom

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Sr. Manager Global Medical Scientific Affairs
Organization
CooperVision
javega@coopervision.com
(925) 621-3761

Study Officials

  • Carole Maldonado-Codina

    University of Manchester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

July 16, 2015

First Posted

July 29, 2015

Study Start

May 1, 2015

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

February 1, 2017

Results First Posted

February 1, 2017

Record last verified: 2017-01

Locations

GB(1)