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Clinical Evaluation of Two Daily Wear Silicon Hydrogel Contact Lens

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02354924
Recruitment Status : Completed
First Posted : February 3, 2015
Results First Posted : April 14, 2017
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
Visco Vision Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Condition Myopia
Interventions Device: Biofinity soft contact lens
Device: Visco soft contact lens
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Visco Soft Contact Lens Biofinity Soft Contact Lens
Hide Arm/Group Description

Olifilcon A, Daily wear, monthly disposable soft contact lens

Visco soft contact lens: Viso soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.

Comfilcon A, Daily wear, monthly disposable soft contact lens

Biofinity soft contact lens: Biofinity soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.

Period Title: Overall Study
Started 40 20
Completed 40 20
Not Completed 0 0
Arm/Group Title Visco Soft Contact Lens Biofinity Soft Contact Lens Total
Hide Arm/Group Description

Olifilcon A, Daily wear, monthly disposable soft contact lens

Visco soft contact lens: Viso soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.

Comfilcon A, Daily wear, monthly disposable soft contact lens

Biofinity soft contact lens: Biofinity soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.

Total of all reporting groups
Overall Number of Baseline Participants 40 20 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 20 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
40
 100.0%
20
 100.0%
60
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 20 participants 60 participants
34.15  (6.44) 36.30  (5.53) 34.87  (6.13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 20 participants 60 participants
Female
35
  87.5%
17
  85.0%
52
  86.7%
Male
5
  12.5%
3
  15.0%
8
  13.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Taiwan Number Analyzed 40 participants 20 participants 60 participants
40
 100.0%
20
 100.0%
60
 100.0%
1.Primary Outcome
Title Visual Acuity
Hide Description Visual acuity correctable to snellen 20/25 or better
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Visco Soft Contact Lens Biofinity Soft Contact Lens
Hide Arm/Group Description:

Olifilcon A, Daily wear, monthly disposable soft contact lens

Visco soft contact lens: Viso soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.

Comfilcon A, Daily wear, monthly disposable soft contact lens

Biofinity soft contact lens: Biofinity soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.

Overall Number of Participants Analyzed 40 20
Overall Number of Units Analyzed
Type of Units Analyzed: Eye
80 40
Count of Units
Unit of Measure: eye
80
 100.0%
40
 100.0%
2.Secondary Outcome
Title Slit Lamp Findings
Hide Description Any slit lamp finding > Grade 2; Measured on a scale of 0-4 with 0=no findings and 4=severe findings
Time Frame 3 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Visco Soft Contact Lens Biofinity Soft Contact Lens
Hide Arm/Group Description:

Olifilcon A, Daily wear, monthly disposable soft contact lens

Visco soft contact lens: Viso soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.

Comfilcon A, Daily wear, monthly disposable soft contact lens

Biofinity soft contact lens: Biofinity soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.

Overall Number of Participants Analyzed 40 20
Overall Number of Units Analyzed
Type of Units Analyzed: Eye
80 40
Count of Units
Unit of Measure: eye
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Symptoms, Problems and Complaints and Incidence Rate
Hide Description Subjective Responses to comfort/symptoms/complaints were measured at every visit. 1=Severe Burning to 10=No Burning for each eye
Time Frame 3 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Visco Soft Contact Lens Biofinity Soft Contact Lens
Hide Arm/Group Description:

Olifilcon A, Daily wear, monthly disposable soft contact lens

Visco soft contact lens: Viso soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.

Comfilcon A, Daily wear, monthly disposable soft contact lens

Biofinity soft contact lens: Biofinity soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.

Overall Number of Participants Analyzed 40 20
Overall Number of Units Analyzed
Type of Units Analyzed: Eye
80 40
Count of Units
Unit of Measure: eye
0
   0.0%
0
   0.0%
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Visco Soft Contact Lens Biofinity Soft Contact Lens
Hide Arm/Group Description

Olifilcon A, Daily wear, monthly disposable soft contact lens

Visco soft contact lens: Viso soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.

Comfilcon A, Daily wear, monthly disposable soft contact lens

Biofinity soft contact lens: Biofinity soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.

All-Cause Mortality
Visco Soft Contact Lens Biofinity Soft Contact Lens
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/20 (0.00%) 
Hide Serious Adverse Events
Visco Soft Contact Lens Biofinity Soft Contact Lens
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/20 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Visco Soft Contact Lens Biofinity Soft Contact Lens
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/20 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Huey-Chuan Cheng
Organization: Mackay Memorial Hospital_Taipei
Phone: 886-2-25433535
EMail: hccheng@ms2.mmh.org.tw
Layout table for additonal information
Responsible Party: Visco Vision Inc.
ClinicalTrials.gov Identifier: NCT02354924    
Other Study ID Numbers: 1000601M
First Submitted: January 29, 2015
First Posted: February 3, 2015
Results First Submitted: November 1, 2016
Results First Posted: April 14, 2017
Last Update Posted: April 14, 2017