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Dispensing Evaluation of a Prototype Contact Lens and a Marketed Contact Lens

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ClinicalTrials.gov Identifier: NCT01094743
Recruitment Status : Completed
First Posted : March 29, 2010
Results First Posted : January 25, 2012
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Myopia
Interventions Device: galyfilcon A prototype lens
Device: lotrafilcon B lens
Enrollment 52
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Galyfilcon A Prototype Lens / Lotrafilcon B Lens
Hide Arm/Group Description All enrolled subjects were to wear both lenses through the course of the study.
Period Title: Period 1
Started 52
Completed 50
Not Completed 2
Reason Not Completed
Unsatisfactory comfort at lens fitting             2
Period Title: Period 2
Started 50
Completed 50
Not Completed 0
Arm/Group Title Galyfilcon A Prototype Lens / Lotrafilcon B Lens
Hide Arm/Group Description All enrolled subjects were to wear both lenses through the course of the study.
Overall Number of Baseline Participants 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants
28  (5.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
Female
17
  32.7%
Male
35
  67.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 52 participants
52
1.Primary Outcome
Title Visual Acuity Monocular
Hide Description Snellen monocular visual acuity measurement
Time Frame after 1 week of lens wear
Hide Outcome Measure Data
Hide Analysis Population Description
All completed subjects
Arm/Group Title Galyfilcon A Prototype Lotrafilcon B
Hide Arm/Group Description:
All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
Overall Number of Participants Analyzed 50 50
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
100 100
Measure Type: Number
Unit of Measure: eyes
20/15 monocular 59 64
20/20 monocular 40 30
20/25 monocular 1 5
20/30 monocular 0 1
2.Primary Outcome
Title Visual Acuity Binocular
Hide Description Snellen binocular visual acuity measurement
Time Frame after 1 week of lens wear
Hide Outcome Measure Data
Hide Analysis Population Description
All completed subjects
Arm/Group Title Galyfilcon A Prototype Lotrafilcon B
Hide Arm/Group Description:
All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
Overall Number of Participants Analyzed 50 50
Measure Type: Number
Unit of Measure: participants
20/15 binocular 40 42
20/20 binocular 10 8
3.Primary Outcome
Title Subjective Assessment of Lens Comfort
Hide Description Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
Time Frame after 1 week of lens wear
Hide Outcome Measure Data
Hide Analysis Population Description
Completed subjects
Arm/Group Title Galyfilcon A Prototype Lotrafilcon B
Hide Arm/Group Description:
All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
66.23  (24.112) 55  (21.844)
4.Primary Outcome
Title Subjective Assessment of Quality of Vision
Hide Description Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
Time Frame after 1 week of lens wear
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Galyfilcon A Prototype Lotrafilcon B
Hide Arm/Group Description:
All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
63.22  (25.345) 59.83  (20.036)
5.Secondary Outcome
Title Limbal Redness
Hide Description Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.
Time Frame after 1 week of lens wear
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Galyfilcon A Prototype Lotrafilcon B
Hide Arm/Group Description:
All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
Overall Number of Participants Analyzed 50 50
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
100 100
Measure Type: Number
Unit of Measure: eyes
Grade 0 None 37 35
Grade 1 Trace 61 61
Grade 2 Mild 2 4
6.Secondary Outcome
Title Bulbar Redness
Hide Description Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.
Time Frame after 1 week of lens wear
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Galyfilcon A Prototype Lotrafilcon B
Hide Arm/Group Description:
All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
Overall Number of Participants Analyzed 50 50
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
100 100
Measure Type: Number
Unit of Measure: eyes
Grade 0 None 44 34
Grade 1 Trace 50 64
Grade 2 Mild 6 2
7.Secondary Outcome
Title Subjective Assessment of Lens Comfort
Hide Description Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
Time Frame 10 minutes after lens insertion at time of initial lens fitting
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Galyfilcon A Prototype Lotrafilcon B
Hide Arm/Group Description:
All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
76.67  (18.487) 65  (19.842)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Galyfilcon A Prototype Lens / Lotrafilcon B Lens
Hide Arm/Group Description All enrolled subjects were to wear both lenses through the course of the study.
All-Cause Mortality
Galyfilcon A Prototype Lens / Lotrafilcon B Lens
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Galyfilcon A Prototype Lens / Lotrafilcon B Lens
Affected / at Risk (%)
Total   0/52 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Galyfilcon A Prototype Lens / Lotrafilcon B Lens
Affected / at Risk (%)
Total   0/52 (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.
Publication requires agreement and written consent from the Sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Huan Sheng, MD, PhD
Organization: Johnson & Johnson Vision Care
Phone: 1-904-443-3440
EMail: HSheng2@its.jnj.com
Layout table for additonal information
Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01094743     History of Changes
Other Study ID Numbers: CR-1636AZ
First Submitted: March 24, 2010
First Posted: March 29, 2010
Results First Submitted: November 7, 2011
Results First Posted: January 25, 2012
Last Update Posted: June 19, 2018