Clincosm LogoSign in Get a demo

Bilateral Dispensing Study of Fanfilcon A Toric Versus Enfilcon A Toric Lenses

Sponsor
Coopervision, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02423109
Collaborator
(none)
44
Enrollment
2
Locations
2
Arms
6
Duration (Months)
22
Patients Per Site
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Bilateral dispensing clinical trial of fanfilcon A toric lens verses enfilcon A toric lens over two weeks.

Condition or Disease Intervention/Treatment Phase
  • Device: fanfilcon A
  • Device: enfilcon A
 N/A

Detailed Description

Evaluation of the clinical performance of an investigational silicone-hydrogel lens called fanfilcon A (test) compared to a FDA-cleared commercially available contact lens called enfilcon A toric lens (control) when worn on a daily wear basis over 2 weeks in a randomized, bilateral, cross-over, dispensing study.

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Bilateral Dispensing Study of Fanfilcon A Toric Versus Enfilcon A Toric Lenses
Study Start Date :
Sep 1, 2015
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: fanfilcon A

Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.

Device: fanfilcon A
contact lens

Device: enfilcon A
contact lens
Active Comparator: enfilcon A

Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.

Device: fanfilcon A
contact lens

Device: enfilcon A
contact lens

Outcome Measures

Primary Outcome Measures

  1. Comfort (Subjective Rating Scale) [Dispensing (Baseline) and 2 weeks]

    Participant rating for comfort at dispense visit and at the 2 week follow-up on a subjective rating scale (0-100, 0=cannot be worn. Causes pain,100=Cannot be felt ever)

  2. Comfort Preference [Dispensing (Baseline) and 2 weeks]

    Subjective assessment for comfort preference for each lens pair. Choices: fanfilcon A lens, enfilcon A lens, No preference.

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Are at least 17 years of age for Canada and 18 years of age for the USA and have full legal capacity to volunteer;

  • Have read and signed an information consent letter;

  • Are willing and able to follow instructions and maintain the appointment schedule;

  • Are an adapted soft contact lens wearer;

  • Require spectacle lens powers in both eyes;

  • Sphere: between -0.50 to -6.00 diopters and

  • Astigmatism: between -1.25 to -2.00 and

  • Axis: 180 ± 20 degrees

  • Are willing to wear contact lens in both eyes;

  • Have 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 including toric orientation as acceptable;

Exclusion Criteria:

  • Are participating in any concurrent clinical or research study;

  • Have any known active* ocular disease and/or infection;

  • Have a systemic condition that in the opinion of the investigator may affect a study outcome variable;

  • Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;

  • Have known sensitivity to the diagnostic pharmaceuticals to be used in the study;

  • Are pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);

  • Are aphakic;

  • Have undergone refractive error surgery;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinical Research Center, University of California, Berkeley Berkeley California United States 94704
2 Center for Contact Lens Research, University of Waterloo Waterloo Ontario Canada N2L 3G1

Sponsors and Collaborators

  • Coopervision, Inc.

Investigators

  • Principal Investigator: Meng Lin, OD PhD, Clinical Research Center, University of California, Berkeley
  • Principal Investigator: Lyndon Jones, PhD FCO, Center for Contact Lens Research, University of Waterloo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT02423109
Other Study ID Numbers:
  • CV-15-13
First Posted:
Apr 22, 2015
Last Update Posted:
Jan 10, 2018
Last Verified:
Jan 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Astigmatism
Hyperopia

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail 44 subjects were enrolled (assigned an ID per protocol), but 11 were not assigned to any group due to screen failure.
Arm/Group Title Randomized for Fanfilcon A Lens First, Then Enfilcon A Lens Randomized for Enfilcon A Lens First, Then Fanfilcon A Lens
Arm/Group Description Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair. fanfilcon A: toric contact lens enfilcon A: toric contact lens Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair. fanfilcon A: toric contact lens enfilcon A: toric contact lens
Period Title: Lens 1
STARTED 19 14
COMPLETED 18 14
NOT COMPLETED 1 0
Period Title: Lens 1
STARTED 18 14
COMPLETED 18 14
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title Overall Study
Arm/Group Description All subjects were wore both fanfilcon A and enfilcon A toric lenses as either the first or second intervention.
Overall Participants 44
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
24
(5)
Sex: Female, Male (Count of Participants)
Female
34
77.3%
Male
10
22.7%

Outcome Measures

1. Primary Outcome
Title Comfort (Subjective Rating Scale)
Description Participant rating for comfort at dispense visit and at the 2 week follow-up on a subjective rating scale (0-100, 0=cannot be worn. Causes pain,100=Cannot be felt ever)
Time Frame Dispensing (Baseline) and 2 weeks

Outcome Measure Data

Analysis Population Description
Analysis population differs slightly due to 1 participant who was excluded from analysis due to a protocol deviation.
Arm/Group Title Fanfilcon A Enfilcon A
Arm/Group Description All participants who wore fanfilcon A lens pair randomly assigned as first or second pair. fanfilcon A: contact lens All participants who wore enfilcon A lens pair randomly assigned as first or second pair. enfilcon A: contact lens
Measure Participants 15 16
Dispensing
87
(17)
88
(10)
2 week
79
(15)
76
(18)
2. Primary Outcome
Title Comfort Preference
Description Subjective assessment for comfort preference for each lens pair. Choices: fanfilcon A lens, enfilcon A lens, No preference.
Time Frame Dispensing (Baseline) and 2 weeks

Outcome Measure Data

Analysis Population Description
Analysis population differs slightly due to protocol deviation.
Arm/Group Title Overall Study - Dispense Overall Study - Follow Up
Arm/Group Description Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair. fanfilcon A: contact lens enfilcon A: contact lens Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair. fanfilcon A: contact lens enfilcon A: contact lens
Measure Participants 31 31
fanfilcon A
12
27.3%
14
NaN
enfilcon A
10
22.7%
12
NaN
No Preference
9
20.5%
5
NaN

Adverse Events

Time Frame Adverse event data were collected through the duration of the study (2 weeks for each lens).
Adverse Event Reporting Description Adverse events data was collected during the follow-up visits and until the subject exited the study.
Arm/Group Title Fanfilcon A Enfilcon A
Arm/Group Description Participants randomized to wear fanfilcon A either as the first or second lens during the cross over study. Participants randomized to wear enfilcon A either as the first or second lens during the cross over study.
All Cause Mortality
Fanfilcon A Enfilcon A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/33 (0%) 0/32 (0%)
Serious Adverse Events
Fanfilcon A Enfilcon A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/33 (0%) 0/32 (0%)
Other (Not Including Serious) Adverse Events
Fanfilcon A Enfilcon A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/33 (0%) 0/32 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Disclosure restriction on the PI is that the sponsor should be notified of any results communications and has ability to review.

Results Point of Contact

Name/Title Myhanh Nguyen, OD
Organization CooperVision
Phone 9257306716
Email mnguyen@coopervision.com
Responsible Party:
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT02423109
Other Study ID Numbers:
  • CV-15-13
First Posted:
Apr 22, 2015
Last Update Posted:
Jan 10, 2018
Last Verified:
Jan 1, 2018