NCT02410824

Brief Summary

Bilateral dispensing clinical trial of stenfilcon A against etafilcon A for astigmatism.

Trial Health

90
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 Apr 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

First Submitted

Initial submission to the registry

March 31, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

March 8, 2017

Completed
Last Updated

August 21, 2017

Status Verified

July 1, 2017

Enrollment Period

2 months

First QC Date

March 31, 2015

Results QC Date

January 18, 2017

Last Update Submit

July 20, 2017

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (12)

  • Comfort

    Subjective ratings of lens performance for comfort assessed at baseline and 1 week. Comfort Scale 0-100, 0=extremely uncomfortable/cannot tolerate, 100=extremely comfortable/cannot be felt.

    Baseline and 1 Week

  • Handling

    Subjective ratings of lens performance for handling assessed at baseline and 1 week. Handling Scale 0-100, 0=very difficult to handle, 100=very easy to handle.

    Baseline and 1 Week

  • Vision

    Subjective ratings of lens performance for vision assessed at baseline and 1 week. Scale 0-100, 0=extremely poor vision all of the time, cannot function, 100=excellent.

    Baseline and 1 Week

  • High Visual Acuity

    High illumination high contrast (HIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR.

    Baseline and 1 Week

  • Low Visual Acuity

    Low illumination high contrast (LIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR.

    Baseline and 1 Week

  • Lens Surface - Wettability

    Lens surface of wettability for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=severely reduced, 4=excellent wettability.

    Baseline and 1 Week

  • Lens Surface - Deposits

    Lens surface of wettability for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=no deposits, 4=severe deposits.

    Baseline and 1 Week

  • Corneal Staining, Type

    Ocular health of corneal staining, type for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=No staining, 4=Severe staining Five quadrants: C - Central, N - Nasal, T - Temporal, S - Superior, I - Inferior

    Baseline and 1 week

  • Corneal Staining, Extent

    Ocular health of corneal staining (extent) for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=No staining 1=1-15% of area 2=16-30% of area 3=31-45% of area 4=\>45% of area Five quadrants: C - Central, N - Nasal, T - Temporal, S - Superior, I - Inferior

    Baseline and 1 week

  • Conjunctival Staining

    Ocular health of conjunctival staining for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Measured in 0.50 steps, scale 0-4, 0=None, 1=Minimal diffuse punctate, 2=Coalescent punctate, 3=Confluent, 4= Deep confluent N - Nasal, T - Temporal, S - Superior, I - Inferior

    Baseline and 1 week

  • Lens Durability

    Lens durability (lens tearing) between stenfilcon A toric lens or etafilcon A toric lens assessed at 1 week. (The number of lens tear or lens nicks found during the one week study).

    1 Week

  • Lens Fit Acceptance

    Lens fit acceptance (on eye stability) for stenfilcon A and etafilcon A assessed at baseline and 1 week. Scale 0-4, 0=Can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.

    Baseline and 1 Week

Secondary Outcomes (2)

  • Dryness

    1 Week

  • Overall Satisfaction

    Baseline and 1 week

Study Arms (2)

stenfilcon A toric lens

EXPERIMENTAL

Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.

Device: stenfilcon A toric lens

etafilcon A toric lens

ACTIVE COMPARATOR

Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.

Device: etafilcon A toric lens

Interventions

stenfilcon A toric lensDEVICE

toric contact lens

stenfilcon A toric lens
etafilcon A toric lensDEVICE

toric contact lens

etafilcon A toric lens

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 a spherical contact lens prescription between -1.00 to -6.00 inclusive in each eye
  • Has spectacle astigmatism: -0.50 to -1.50D (Diopter) cylinder (Axis: 90±20, 180±20 in both eyes);
  • Willing to wear contact lens in both eyes for at least 8 hours per day, 7 days per week;
  • 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 (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

Astigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Sr. Manager Clinical Research
Organization
CooperVision Inc.
pchamberlain@coopervision.com
925-730-6754

Study Officials

  • Meng C Lin, OD PhD

    UC Berkeley Clinical Research Center

    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
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2015

First Posted

April 8, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

August 21, 2017

Results First Posted

March 8, 2017

Record last verified: 2017-07

Locations

US(1)CA(1)