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Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses

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ClinicalTrials.gov Identifier: NCT02956460
Recruitment Status : Completed
First Posted : November 7, 2016
Results First Posted : December 8, 2017
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Myopia
Interventions Device: fanfilcon A
Device: senofilcon A
Enrollment 64
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fanfilcon A First Then Senofilcon A Senofilcon A First Then Fanfilcon A
Hide Arm/Group Description Participants are randomized to wear fanfilcon A for two weeks then senofilcon A Participants are randomized to wear senofilcon A for two weeks then fanfilcon A
Period Title: Lens 1
Started 30 34
Completed 29 34
Not Completed 1 0
Reason Not Completed
Lost to Follow-up             1             0
Period Title: Lens 2
Started 29 34
Completed 29 34
Not Completed 0 0
Arm/Group Title Fanfilcon A First Then Senofilcon A Senofilcon A First Then Fanfilcon A Total
Hide Arm/Group Description Participants are randomized to wear fanfilcon A for two weeks then senofilcon A Participants are randomized to wear senofilcon A for two weeks then fanfilcon A Total of all reporting groups
Overall Number of Baseline Participants 30 34 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 34 participants 64 participants
31.6  (6.1) 29.6  (5.6) 30.5  (5.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 34 participants 64 participants
Female
24
  80.0%
28
  82.4%
52
  81.3%
Male
6
  20.0%
6
  17.6%
12
  18.8%
1.Primary Outcome
Title Overall Comfort
Hide Description Subjective assessment for comfort is assessed. Scale 0-10, 0=painful, 10=can't feel
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fanfilcon A Senofilcon A
Hide Arm/Group Description:
Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.
Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
Overall Number of Participants Analyzed 63 63
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.4  (1.9) 8.7  (1.5)
2.Primary Outcome
Title Overall Dryness
Hide Description Subjective ratings for dryness is assessed on a scale of 0-10, 0=extremely dry, 10=no dryness
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fanfilcon A Senofilcon A
Hide Arm/Group Description:
Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.
Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
Overall Number of Participants Analyzed 63 63
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.2  (1.9) 8.2  (1.9)
3.Primary Outcome
Title Vision Quality
Hide Description Subjective ratings of vision quality is assessed on a scale 0-10, 0=not sharp/not clear, 10=sharp/clear
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fanfilcon A Senofilcon A
Hide Arm/Group Description:
Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.
Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
Overall Number of Participants Analyzed 63 63
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.0  (1.5) 8.9  (1.6)
4.Primary Outcome
Title Lens Handling
Hide Description Subjective ratings of lens handling - insertion and removal - is assessed using scale 0-10, 0=difficult to handle, 10=very easy to handle
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fanfilcon A Senofilcon A
Hide Arm/Group Description:
Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.
Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
Overall Number of Participants Analyzed 63 63
Mean (Standard Deviation)
Unit of Measure: units on a scale
Insertion 9.3  (1.3) 9.4  (1.2)
Removal 8.4  (2.0) 9.3  (1.3)
5.Primary Outcome
Title Vision Satisfaction
Hide Description Subjective ratings of vision satisfaction is assessed on a scale 0-10, 0=completely dissatisfied, 10=completely satisfied.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fanfilcon A Senofilcon A
Hide Arm/Group Description:
Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.
Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
Overall Number of Participants Analyzed 63 63
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.7  (2.1) 8.6  (1.7)
6.Primary Outcome
Title Lens Centration
Hide Description Lens centration will be recorded by degree and direction in the primary position. (Optimum, decentration acceptable, decentration unacceptable).
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fanfilcon A Senofilcon A
Hide Arm/Group Description:
Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.
Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
Overall Number of Participants Analyzed 63 63
Measure Type: Count of Participants
Unit of Measure: Participants
Optimum
62
  98.4%
63
 100.0%
Acceptable
1
   1.6%
0
   0.0%
Unacceptable
0
   0.0%
0
   0.0%
7.Primary Outcome
Title Conjunctival Staining
Hide Description

Assessed using slit lamp with blue light and sodium fluorescein, low medium magnification.

0=None, no staining present

  1. Very slight
  2. Slight
  3. Moderate
  4. Severe
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fanfilcon A Senofilcon A
Hide Arm/Group Description:
Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.
Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
Overall Number of Participants Analyzed 63 63
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.4  (0.7) 0.6  (0.8)
8.Primary Outcome
Title Smoothness
Hide Description Subjective ratings for lens sensation of smoothness is assessed on a scale 0-10, 0=not smooth at all, 10=totally smooth
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fanfilcon A Senofilcon A
Hide Arm/Group Description:
Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.
Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
Overall Number of Participants Analyzed 63 63
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.7  (1.7) 9.1  (1.4)
9.Primary Outcome
Title Clean Feeling
Hide Description Subjective ratings for lens clean feeling is assessed on a scale 0-10, 0=not clean at all, 10=lenses feel perfectly clean
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fanfilcon A Senofilcon A
Hide Arm/Group Description:
Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.
Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
Overall Number of Participants Analyzed 63 63
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.7  (1.7) 8.9  (1.4)
10.Primary Outcome
Title Lens Hydrated
Hide Description Subjective ratings for lens sensation is assessed on a scale 0-10, 0=totally dehydrated, 10=totally hydrated
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fanfilcon A Senofilcon A
Hide Arm/Group Description:
Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.
Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
Overall Number of Participants Analyzed 63 63
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.3  (2.0) 8.5  (1.6)
11.Primary Outcome
Title Lens Wettability
Hide Description Subjective ratings for lens wettability is assessed on a scale 0-10, 0=non-wettable, 10=highly wettable
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fanfilcon A Senofilcon A
Hide Arm/Group Description:
Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.
Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
Overall Number of Participants Analyzed 63 63
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.4  (1.9) 8.5  (1.6)
Time Frame Adverse event data was collected over the 2 week period for each lens
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fanfilcon A Senofilcon A
Hide Arm/Group Description Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study
All-Cause Mortality
Fanfilcon A Senofilcon A
Affected / at Risk (%) Affected / at Risk (%)
Total   0/63 (0.00%)   0/63 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Fanfilcon A Senofilcon A
Affected / at Risk (%) Affected / at Risk (%)
Total   0/63 (0.00%)   0/63 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fanfilcon A Senofilcon A
Affected / at Risk (%) Affected / at Risk (%)
Total   0/63 (0.00%)   0/63 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Disclosure restriction on the PI is that the sponsor should be notified of any use of study data for results communication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jose Vega, O.D., MSc., FAAO
Organization: CooperVision
Phone: 925-621-3761
EMail: JVega2@coopervision.com
Layout table for additonal information
Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT02956460     History of Changes
Other Study ID Numbers: EX-MKTG-73
First Submitted: November 3, 2016
First Posted: November 7, 2016
Results First Submitted: November 10, 2017
Results First Posted: December 8, 2017
Last Update Posted: April 2, 2018