Endothelial Bleb Response With Toric Lenses
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ClinicalTrials.gov Identifier: NCT00630305 |
Recruitment Status
:
Completed
First Posted
: March 7, 2008
Results First Posted
: March 3, 2017
Last Update Posted
: March 3, 2017
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Sponsor:
Johnson & Johnson Vision Care, Inc.
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.
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Tracking Information | ||||
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First Submitted Date ICMJE | February 28, 2008 | |||
First Posted Date ICMJE | March 7, 2008 | |||
Results First Submitted Date | March 26, 2014 | |||
Results First Posted Date | March 3, 2017 | |||
Last Update Posted Date | March 3, 2017 | |||
Study Start Date ICMJE | January 2008 | |||
Actual Primary Completion Date | July 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Grade of percent of endothelial blebs in the following locations; Central, Nasal, Temporal, Inferior, Superior [ Time Frame: 20 minutes ] | |||
Change History | Complete list of historical versions of study NCT00630305 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Endothelial Bleb Response With Toric Lenses | |||
Official Title ICMJE | Evaluation of the Short-Term Corneal Endothelial Response to Wear of Toric Soft Contact Lenses in Asian Eyes | |||
Brief Summary | Evaluate the short-term corneal response of oxygen deprivation when using toric contact lenses. The response will be noted by endothelial bleb formation in both open eye and closed eye state. | |||
Detailed Description | Interested subjects who meet the entry criteria for the study will be scheduled for four sessions of approximately 30 minutes duration each. Informed consent obtained. Baseline measurements of visual acuity and corneal and conjunctival physiology will be recorded. An examination of the endothelium of the corneas will be conducted using the specular microscope, readings obtained at 5 locations on each cornea: one in the centre and one in each of the superior, inferior, nasal and temporal peripheral regions, approximately 2mm from the limbal margin. The assigned lenses will be inserted according to a fixed-allocation randomization schedule, where each session follows an optimized 2- period simultaneous crossover design, which specifies lenses to be used in each of the four sessions. Lenses will be worn for 20 minutes and then removed. Endothelial specular microscopy will be conducted at 20 minutes with the lenses on. A final evaluation of corneal and conjunctival physiology will be performed prior to subject clearance from the study. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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Condition ICMJE | Ametropia | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
37 | |||
Original Estimated Enrollment ICMJE |
35 | |||
Actual Study Completion Date | July 2008 | |||
Actual Primary Completion Date | July 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00630305 | |||
Other Study ID Numbers ICMJE | CR-0726 JJO0717 |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Johnson & Johnson Vision Care, Inc. | |||
Study Sponsor ICMJE | Johnson & Johnson Vision Care, Inc. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Johnson & Johnson Vision Care, Inc. | |||
Verification Date | January 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |