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

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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Test/Control - Phase 1 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.
Control/Test - Phase 1 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.
Test/Control - Phase 2 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.
Control/Test - Phase 2 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.

Participant Flow for 3 periods

Period 1:   Phase I - Contralateral
    Test/Control - Phase 1   Control/Test - Phase 1   Test/Control - Phase 2   Control/Test - Phase 2
STARTED   34   37   0   0 
COMPLETED   19   27   0   0 
NOT COMPLETED   15   10   0   0 
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 2:   Phase II - Period 1 Bilateral
    Test/Control - Phase 1   Control/Test - Phase 1   Test/Control - Phase 2   Control/Test - Phase 2
STARTED   0   0   23   23 
COMPLETED   0   0   23   22 
NOT COMPLETED   0   0   0   1 
Adverse Event                0                0                0                1 

Period 3:   Phase II - Period 2 Bilateral
    Test/Control - Phase 1   Control/Test - Phase 1   Test/Control - Phase 2   Control/Test - Phase 2
STARTED   0   0   23   22 
COMPLETED   0   0   23   22 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects that were dispensed at least one study lens.

Reporting Groups
  Description
Dispensed Subjects All subjects that were dispensed at least one study lens throughout the course of the study.

Baseline Measures
   Dispensed Subjects 
Overall Participants Analyzed 
[Units: Participants]
 71 
Age 
[Units: Years]
Mean (Standard Deviation)
 28.7  (6.24) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      43  60.6% 
Male      28  39.4% 
Region of Enrollment 
[Units: Participants]
 
United States   71 


  Outcome Measures

1.  Primary:   Correlation Between Subjective CLUE Comfort and Keratometry   [ Time Frame: 3-day follow-up ]

2.  Primary:   Correlation Between Subjective CLUE Comfort and Corneal Diameter   [ Time Frame: 3-day follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: ale3@ITS.JNJ.com



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