NCT02345811

Brief Summary

To evaluate the clinical performance of an investigational silicone-hydrogel lens when worn on a daily wear modality over two weeks of lens wear.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
2 countries

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

January 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

September 16, 2020

Completed
Last Updated

September 16, 2020

Status Verified

July 1, 2020

Enrollment Period

2 months

First QC Date

January 14, 2015

Results QC Date

August 25, 2020

Last Update Submit

August 25, 2020

Conditions

MyopiaHyperopia

Outcome Measures

Primary Outcomes (14)

  • Vision Quality

    Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)

    Baseline (10 minutes post lens settling at dispense)

  • Vision Quality

    Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)

    2 weeks - During the Day

  • Vision Quality

    Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)

    2 weeks - End of Day

  • Subjective Rating for Comfort.

    Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever

    Baseline - 10 minutes post lens settling

  • Subjective Rating for Comfort.

    Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever

    2-weeks - During the Day

  • Subjective Rating for Comfort.

    Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever

    2-weeks - End of Day

  • Lens Surface Wettability

    Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent)

    Baseline (10 minutes post lens settling)

  • Lens Surface Wettability

    Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent)

    2 weeks

  • Surface Deposits

    Surface deposits is assessed. (Scale 0-4,0.25 steps) (0=no deposits; 1 = \<5 deposits; 2 = \>5 deposits or film 25-50% of surface; 3 = deposits 0.1 - 0.5mm or film 50-75% of surface; 4 = deposits \>0.5mm or film \> 75% of surface)

    Baseline (10 minutes post lens settling)

  • Surface Deposits

    Surface deposits is assessed. (Scale 0-4,0.25 steps) (0=no deposits; 1 = \<5 deposits; 2 = \>5 deposits or film 25-50% of surface; 3 = deposits 0.1 - 0.5mm or film 50-75% of surface; 4 = deposits \>0.5mm or film \> 75% of surface)

    2-weeks

  • Lens Handling (Ease of Insertion)

    Lens handling - ease of insertion of the lenses. Scale 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye.

    2 weeks

  • Lens Handling (Ease of Removal)

    Lens handling - ease of removal of the lenses. Scale 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye.

    2 weeks

  • Subjective Preference for Comfort.

    Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever

    Baseline - 10 minutes post lens settling

  • Subjective Preference for Comfort.

    Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever

    2 weeks

Study Arms (2)

Sapphire

EXPERIMENTAL

Participants were randomized to wear the Sapphire lens pair for two weeks during the cross over study.

Device: Sapphire

senofilcon A

ACTIVE COMPARATOR

Participants were randomized to wear the senofilcon A lens pair for two weeks during the cross over study.

Device: senofilcon A

Interventions

SapphireDEVICE

silicone-hydrogel contact lens

Sapphire
senofilcon ADEVICE

contact lens

senofilcon A

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Is at least 17 years of age for Canada and 18 years of age for the USA and has full legal capacity to volunteer
  • Has read and signed an information consent letter
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Is an adapted soft contact lens wearer
  • Requires spectacle lens powers between -0.50 to -6.00 diopters sphere (0.25D steps) or +1.00 to +8.00 diopters sphere (1.00D steps)
  • Has no more than 0.75 diopters of refractive astigmatism
  • Willing to wear contact lens in both eyes
  • Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye
  • To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit as acceptable

You may not qualify if:

  • Is participating in any concurrent clinical or research study
  • Has any known active\* ocular disease and/or infection
  • 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 a study outcome variable
  • Has known sensitivity to the diagnostic pharmaceuticals to be used in the study
  • Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit)
  • Is aphakic
  • Has undergone refractive error surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinical Research Center, University of California, Berkeley

Berkeley, California, 94704, United States

Location

Center for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

MyopiaHyperopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

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

Study Officials

  • Meng Lin, OD PhD

    University of California, Berkeley

    PRINCIPAL INVESTIGATOR

  • Lyndon Jones, PhD FCO

    University of Waterloo CCLR

    PRINCIPAL INVESTIGATOR

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, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2015

First Posted

January 26, 2015

Study Start

January 1, 2015

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

September 16, 2020

Results First Posted

September 16, 2020

Record last verified: 2020-07

Locations

CA(1)US(1)