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Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process

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ClinicalTrials.gov Identifier: NCT03605303
Recruitment Status : Terminated (This study was terminated due to the released lenses not representing what will be made commercially available and thus the objectives could not be met)
First Posted : July 30, 2018
Results First Posted : July 24, 2019
Last Update Posted : August 28, 2019
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 Refractive Error Correction
Interventions Device: Test/Control
Device: Control/Test
Enrollment 3
Recruitment Details On July 06, 2018 Johnson & Johnson Vision terminated this study prematurely after lens testing revealed that the lens thickness in the mid-periphery of the lens were thinner than the lens design targets. As of this date only 3 subjects were enrolled at 1 site.
Pre-assignment Details  
Arm/Group Title Test/Control Control/Test
Hide Arm/Group Description Subjects that were radnomized to wear the Test lens during the period and the Control lens during the second period. Both study lens was was to be worn bilaterally for a period of 1-week each. Subjects that were radnomized to wear the Control lens during the period and the Test lens during the second period. Both study lens was was to be worn bilaterally for a period of 1-week each.
Period Title: Period 1
Started 2 1
Completed 0 0
Not Completed 2 1
Reason Not Completed
Study Terminated             2             1
Period Title: Period 2
Started 0 0
Completed 0 0
Not Completed 0 0
Arm/Group Title All Enrolled Subjects
Hide Arm/Group Description All subjects enrolled into th study
Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
2
  66.7%
Male
1
  33.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants
Black or African American 1
White 1
Native Hawaiian or Other Pacfic Islander 1
1.Primary Outcome
Title Overall Comfort Scores
Hide Description Subjective assessment of comfort will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.
Time Frame 1-Week Follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early. No data was analyzed.
Arm/Group Title Test Control
Hide Arm/Group Description:
subjects that were randomized to receive the Test lens in either period of the study.
All subject that were randomized to the Control lens during either period of the study.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Overall Vision Score
Hide Description Subjective assessment of vision will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.
Time Frame 1-Week Follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early. No data was analyzed.
Arm/Group Title Test Control
Hide Arm/Group Description:
subjects that were randomized to receive the Test lens in either period of the study.
All subject that were randomized to the Control lens during either period of the study.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Throughout the entire duration of the study. Approxmiately 3 days per subject.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Test Control
Hide Arm/Group Description Subjects that wore the Test lens during any time throughout the duration of the study. Subjects that wore the Control lens during any time throughout the duration of the study.
All-Cause Mortality
Test Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Test Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Test Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%) 
This study was terminated after additional lens metrology testing revealed that the lens thickness of the contact lenses were thinner than the lens design targets. This reduction in thickness may have altered the handling of the contact lenses.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Brian Pall OD, MS, FAAO - Director of Clinical Sciences
Organization: Johnson & Johnson Vision Care Inc.
Phone: 9044431290
EMail: BPALL@its.jnj.com
Layout table for additonal information
Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT03605303     History of Changes
Other Study ID Numbers: CR-6270
First Submitted: July 20, 2018
First Posted: July 30, 2018
Results First Submitted: July 3, 2019
Results First Posted: July 24, 2019
Last Update Posted: August 28, 2019