ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of 8.5 vs 9.0 Base Curve for 1-DAY ACUVUE(r) TruEye(r) Brand Contact Lenses

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: NCT02537522
Recruitment Status : Completed
First Posted : September 1, 2015
Results First Posted : January 10, 2017
Last Update Posted : July 11, 2017
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: Other
Condition Contact Lens Base Curve (BC) Fit and Comfort
Interventions Device: Contact Lenses with 8.5 BC
Device: Contact Lenses with 9.0 BC
Enrollment 72
Recruitment Details  
Pre-assignment Details A total of 72 subjects were enrolled into this study. Of the enrolled subjects 1 did not meet the eligibility criteria and 71 were dispensed lenses. Of the dispensed subjects 45 completed both Phase I and II while 26 subjects were discontinued.
Arm/Group Title Test/Control - Phase 1 Control/Test - Phase 1 Test/Control - Phase 2 Control/Test - Phase 2
Hide Arm/Group Description Subjects randomized to this sequence in Phase I wore the test lens narafilcon A with 8.5 Base Curve in their left eye and then wore the narafilcon A with 9.0 Base Curve in their right eye. Subjects randomized to this sequence in Phase I wore the test lens narafilcon A with 9.0 Base Curve in their left eye and then wore the narafilcon A with 8.5 Base Curve in their right eye. Subjects randomized to this sequence in Phase II wore the narafilcon A lens with 8.5 Base Curve in both eyes and then wore narafilcon A lens with 9.0 Base Curve in both eyes. Subjects randomized to this sequence in Phase II wore the narafilcon A lens with 9.0 Base Curve in both eyes and then wore narafilcon A lens with 8.5 Base Curve in both eyes.
Period Title: Phase I - Contralateral
Started 34 37 0 0
Completed 19 27 0 0
Not Completed 15 10 0 0
Reason Not Completed
Subject no longer eligible             15             7             0             0
Withdrawal by Subject             0             1             0             0
incorrect randomization             0             1             0             0
unsatisfactory lens fitting             0             1             0             0
Period Title: Phase II - Period 1 Bilateral
Started 0 0 23 23
Completed 0 0 23 22
Not Completed 0 0 0 1
Reason Not Completed
Adverse Event             0             0             0             1
Period Title: Phase II - Period 2 Bilateral
Started 0 0 23 22
Completed 0 0 23 22
Not Completed 0 0 0 0
Arm/Group Title Dispensed Subjects
Hide Arm/Group Description All subjects that were dispensed at least one study lens throughout the course of the study.
Overall Number of Baseline Participants 71
Hide Baseline Analysis Population Description
All subjects that were dispensed at least one study lens.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 71 participants
28.7  (6.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants
Female
43
  60.6%
Male
28
  39.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 71 participants
71
1.Primary Outcome
Title Correlation Between Subjective CLUE Comfort and Keratometry
Hide Description CLUE- The Contact Lens User Evaluation (CLUE)™ questionnaire is 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. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ. Et al. August 2016). Keratometry measurements of major keratometric meridians (diopter [DK]) and their location (degrees) was collected at baseline for both eyes. The correlation between CLUE comfort and maximum Keratometry measurements of the two eyes within each subject and the correlation between CLUE comfort and the minimum Keratometry measurements of the two eyes within each subject were reported.
Time Frame 3-day follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects that completed all study visits without a major protocol deviation.
Arm/Group Title Narafilcon A- 8.5 Base Curve Narafilcon A- 9.0 Base Curve
Hide Arm/Group Description:
Subjects that wore the narafilcon A lens with 8.5 Base Curve in either the 1st or 2nd period of the study during either Phase II.
Subjects that wore the narafilcon A lens with 9.0 Base Curve in either the 1st or 2nd period of the study during either Phase II.
Overall Number of Participants Analyzed 43 43
Measure Type: Number
Unit of Measure: Pearson Correlation
Minimum Keratometry measurements 0.042 0.004
Maximum Keratometry measurements -0.001 -0.002
2.Primary Outcome
Title Correlation Between Subjective CLUE Comfort and Corneal Diameter
Hide Description Assessment The Contact Lens User Evaluation (CLUE)™ questionnaire is 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. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ Et al. August 2016). Corneal diameter (horizontal visible iris diameter [HVID]) was collected at baseline for both eyes using a slit lamp reticle, measuring to the nearest 0.05 mm.The maximum (or minimum) measurements of HVID between the two eyes of each subject were used for correlation analyses between subjective CLUE comfort score and corneal diameter.
Time Frame 3-day follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects that completed all study visits without a major protocol deviation.
Arm/Group Title Narafilcon A- 8.5 Base Curve Narafilcon A- 9.0 Base Curve
Hide Arm/Group Description:
Subjects that wore the narafilcon A lens with 8.5 Base Curve in either the 1st or 2nd period of the study during either Phase II.
Subjects that wore the narafilcon A lens with 9.0 Base Curve in either the 1st or 2nd period of the study during either Phase II.
Overall Number of Participants Analyzed 43 43
Measure Type: Number
Unit of Measure: Pearson Correlation
Minimum Corneal diameter 0.011 -0.086
Maximum Corneal diameter 0.021 -0.119
Time Frame Throughout the duration of the study. Approximately 1-week per subject.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Narafilcon A- 8.5 Base Curve Narafilcon A- 9.0 Base Curve
Hide Arm/Group Description Subjects that wore the narafilcon A lens with 8.5 Base Curve in either the 1st or 2nd period of the study during either Phase II. Subjects that wore the narafilcon A lens with 9.0 Base Curve in either the 1st or 2nd period of the study during either Phase II.
All-Cause Mortality
Narafilcon A- 8.5 Base Curve Narafilcon A- 9.0 Base Curve
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Narafilcon A- 8.5 Base Curve Narafilcon A- 9.0 Base Curve
Affected / at Risk (%) Affected / at Risk (%)
Total   0/71 (0.00%)   0/71 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Narafilcon A- 8.5 Base Curve Narafilcon A- 9.0 Base Curve
Affected / at Risk (%) Affected / at Risk (%)
Total   0/71 (0.00%)   0/71 (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.
Results Point of Contact
Name/Title: Andrea Le, OD -Manager Global Medical Affairs
Organization: Johnson & Johnson Vision Care Inc.
Phone: 904 4431866
Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT02537522     History of Changes
Other Study ID Numbers: CR-5730
First Submitted: August 28, 2015
First Posted: September 1, 2015
Results First Submitted: November 11, 2016
Results First Posted: January 10, 2017
Last Update Posted: July 11, 2017