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Trial record 1 of 1 for:    NCT01250925
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Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01250925
First Posted: December 1, 2010
Last Update Posted: January 10, 2017
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.
Collaborators:
University of Iowa
Alcon Research
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
Results First Submitted: April 24, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Supportive Care
Conditions: Myopia
Refractive Error
Interventions: Drug: ReNu MultiPlus® MultiPurpose Solution
Drug: OPTI-FREE® RepleniSH®
Drug: Clear Care®

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
94 Neophyte contact lens wearers were fitted for one of 3 types of contact lenses (Bausch and Lomb PureVision; Vistakon Acuvue Oasys or Cooper Vision Biofinity) and were then randomized into one of three test articles (care regimens): OptiFree RepleniSH Multi-Purpose Disinfecting Solution, Clear Care or ReNu MultiPlus Multi-Purpose Solution.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
127 subjects were screened, out of which 94 were successfully enrolled and 35 were screenfailed due to non-normal clinical findings. Of the enrolled, 10 did not complete the study visits.

Reporting Groups
  Description
OPTI-FREE® RepleniSH® 33 participants will be assigned to use this lens care regimen during the six-week assessment period
Clear Care® 33 participants will be assigned to use this lens care regimen during the six-week assessment period
ReNu MultiPlus® MultiPurpose Solution 33 participants will be assigned to use this lens care regimen during the six-week assessment period

Participant Flow:   Overall Study
    OPTI-FREE® RepleniSH®   Clear Care®   ReNu MultiPlus® MultiPurpose Solution
STARTED   31   31   32 
COMPLETED   26   28   30 
NOT COMPLETED   5   3   2 
Lost to Follow-up                1                1                0 
Withdrawal by Subject                2                0                0 
Protocol Violation                2                0                0 
Physician Decision                0                2                1 
Adverse Event                0                0                1 



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
OPTI-FREE® RepleniSH® 33 participants will be assigned to use this lens care regimen during the six-week assessment period
Clear Care® 33 participants will be assigned to use this lens care regimen during the six-week assessment period
ReNu MultiPlus® MultiPurpose Solution 33 participants will be assigned to use this lens care regimen during the six-week assessment period
Total Total of all reporting groups

Baseline Measures
   OPTI-FREE® RepleniSH®   Clear Care®   ReNu MultiPlus® MultiPurpose Solution   Total 
Overall Participants Analyzed 
[Units: Participants]
 31   31   32   94 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      31 100.0%      31 100.0%      32 100.0%      94 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 30.7  (10.3)   32.9  (12.2)   30.6  (9.1)   31.4  (10.5) 
Gender 
[Units: Participants]
Count of Participants
       
Female      23  74.2%      18  58.1%      14  43.8%      55  58.5% 
Male      8  25.8%      13  41.9%      18  56.3%      39  41.5% 
Region of Enrollment 
[Units: Participants]
       
United States   31   31   32   94 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Corneal Epithelial Immune Dendritic Cell Density (Central Cornea)   [ Time Frame: Six weeks ]

2.  Primary:   Corneal Epithelial Immune Dendritic Cell Density (Inferior Cornea)   [ Time Frame: Six weeks ]

3.  Primary:   Corneal Epithelial Immune Dendritic Cell Density (Nasal Cornea)   [ Time Frame: Six weeks ]

4.  Primary:   Corneal Epithelial Immune Dendritic Cell Density (Superior Cornea)   [ Time Frame: Six weeks ]

5.  Primary:   Corneal Epithelial Immune Dendritic Cell Density (Temporal Cornea)   [ Time Frame: Six weeks ]

6.  Primary:   Corneal Epithelial Immune Non-Dendritic Cell Density (Central Cornea)   [ Time Frame: Six weeks ]

7.  Primary:   Corneal Epithelial Immune Non-Dendritic Cell Density (Inferior Cornea)   [ Time Frame: Six weeks ]

8.  Primary:   Corneal Epithelial Immune Non-Dendritic Cell Density (Nasal Cornea)   [ Time Frame: Six weeks ]

9.  Primary:   Corneal Epithelial Immune Non-Dendritic Cell Density (Superior Cornea)   [ Time Frame: Six weeks ]

10.  Primary:   Corneal Epithelial Immune Non-Dendritic Cell Density (Temporal Cornea)   [ Time Frame: Six weeks ]

11.  Secondary:   Number of Participants With Slit-lamp Findings, Corrected Visual Acuity (Snellen) and Adverse Events   [ Time Frame: Six weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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 more than 60 days but less than or equal to 180 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: Dr. Pedram Hamrah
Organization: Massachusetts Eye and Ear Infirmary
phone: 617-573-3313
e-mail: cornea_research@meei.harvard.edu



Responsible Party: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01250925     History of Changes
Other Study ID Numbers: 10-04-029
First Submitted: November 29, 2010
First Posted: December 1, 2010
Results First Submitted: April 24, 2013
Results First Posted: January 10, 2017
Last Update Posted: January 10, 2017