Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Clinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population.

This study has been completed.
Sponsor:
Collaborator:
University of Manchester
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT00708032
First received: June 27, 2008
Last updated: July 17, 2014
Last verified: July 2014
Results First Received: November 3, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Refractive Error
Myopia
Interventions: Device: spectacles
Device: narafilcon A soft contact lenses

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
There were 74 subjects enrolled into the study, 38 into the TruEye group and 36 in the spectacle group. Forty-eight subjects completed the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Spectacles spectacles worn daily for 12 months
Narafilcon A Lenses narafilcon A soft contact lenses worn as daily disposable for 12 months

Participant Flow:   Overall Study
    Spectacles     Narafilcon A Lenses  
STARTED     36     38  
COMPLETED     26     22  
NOT COMPLETED     10     16  
Adverse Event                 0                 2  
Lost to Follow-up                 1                 2  
Pregnancy                 0                 1  
Poor vision                 0                 6  
Visit out of range at month 12                 4                 1  
Did not meet protocol criteria                 1                 2  
Protocol Violation                 4                 1  
Withdrawal by Subject                 0                 1  



  Baseline Characteristics
  Hide 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.
There were 74 subjects enrolled with 48 completing the study.

Reporting Groups
  Description
Spectacles spectacles worn daily for 12 months
Narafilcon A Lenses narafilcon A soft contact lenses worn as daily disposable for 12 months
Total Total of all reporting groups

Baseline Measures
    Spectacles     Narafilcon A Lenses     Total  
Number of Participants  
[units: participants]
  36     38     74  
Age  
[units: years]
Mean ± Standard Deviation
  26.5  ± 8.1     26.5  ± 7.4     26.5  ± 7.7  
Gender  
[units: participants]
     
Female     16     19     35  
Male     20     19     39  
Region of Enrollment  
[units: participants]
     
United Kingdom     36     38     74  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Papillary Conjunctivitis   [ Time Frame: 12 months ]
  Hide Outcome Measure 1

Measure Type Primary
Measure Title Papillary Conjunctivitis
Measure Description Papillary conjunctivitis which is collected as part of the biomicroscopy data and is identified from a slit lamp examination. Grade 0 to Grade 4 with grade 0 implying no health concerns.
Time Frame 12 months  
Safety Issue No  

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.
Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.

Reporting Groups
  Description
Narafilcon A Lenses narafilcon A soft contact lenses worn as daily disposable for 12 months
Spectacles habitual spectacles worn daily for 12 months

Measured Values
    Narafilcon A Lenses     Spectacles  
Number of Participants Analyzed  
[units: participants]
  22     26  
Papillary Conjunctivitis  
[units: units on a scale]
Mean ± Standard Deviation
  1.22  ± 0.21     1.04  ± 0.26  

No statistical analysis provided for Papillary Conjunctivitis



2.  Secondary:   Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis.   [ Time Frame: at 12 months ]

3.  Secondary:   Visual Acuity After 12 Months of Wear   [ Time Frame: at 12 months ]

4.  Secondary:   Subjective Overall Comfort After 12 Months of Daily Wear   [ Time Frame: at 12 months ]

5.  Secondary:   Subjective Overall Vision After 12 Months of Daily Wear   [ Time Frame: at 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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