Evaluation of Orientation and Visual Acuity of Four Toric Soft Contact Lenses When Head is Tilted at 90 Degrees
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| ClinicalTrials.gov Identifier: NCT00583908 |
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Recruitment Status :
Completed
First Posted : January 2, 2008
Results First Posted : September 28, 2009
Last Update Posted : May 21, 2015
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Sponsor:
Johnson & Johnson Vision Care, Inc.
Collaborator:
Visioncare Research Ltd.
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.
- Study Details
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Participant); Primary Purpose: Treatment |
| Condition |
Astigmatism |
| Interventions |
Device: senofilcon A Device: balafilcon A toric Device: lotrafilcon B toric Device: omafilcon A |
| Enrollment | 14 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Lotrafilcon B / Senofilcon A / Balafilcon A / Omafilcon A | Lotrafilcon B / Omafilcon A / Senofilcon A / Balafilcon A | Lotrafilcon B / Balafilcon A / Senofilcon A / Omafilcon A | Senofilcon A / Lotrafilcon B / Omafilcon A / Balafilcon A | Senofilcon A / Omafilcon A / Balafilcon A / Lotrafilcon B | Senofilcon A / Balafilcon A / Lotrafilcon B / Omafilcon A | Omafilcon A / Lotrafilcon B / Senofilcon A / Balafilcon A | Balafilcon A / Lotrafilcon B / Senofilcon A / Omafilcon A | Balafilcon A / Lotrafilcon B / Omafilcon A / Senofilcon A | Balafilcon A / Senofilcon A / Lotrafilcon B / Omafilcon A | Balafilcon A / Senofilcon A / Omafilcon A / Lotrafilcon A | Balafilcon A / Omafilcon A / Lotrafilcon B / Senofilcon A |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
 Arm/Group Description |
All lenses were toric lenses. The order of lenses in the title relates to the period of administration. | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. |
| Period Title: Period 1 - First Intervention | ||||||||||||
| Started | 1 | 2 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
| Completed | 1 | 2 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
| Not Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Period Title: Period 2 - Second Intervention | ||||||||||||
| Started | 1 | 2 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
| Completed | 1 | 2 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
| Not Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Period Title: Period 3 - Third Intervention | ||||||||||||
| Started | 1 | 2 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
| Completed | 1 | 2 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
| Not Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Period Title: Period 4 - Fourth Intervention | ||||||||||||
| Started | 1 | 2 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
| Completed | 1 | 2 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
| Not Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Overall Study Population | |
|---|---|---|
|
Arm/Group Description |
Summary for overall study population | |
| Overall Number of Baseline Participants | 14 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 14 participants | |
| 42.1 (6.0) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 14 participants | |
| Female |
9 64.3%
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| Male |
5 35.7%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United Kingdom | Number Analyzed | 14 participants |
| 14 | ||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.
Results Point of Contact
| Name/Title: | Kurt Moody, OD FAAO |
| Organization: | Vistakon |
| Phone: | 904-443-3088 |
| EMail: | kmoody1@its.jnj.com |
| Responsible Party: | Johnson & Johnson Vision Care, Inc. |
| ClinicalTrials.gov Identifier: | NCT00583908 |
| Other Study ID Numbers: |
CR-0710 pt 3 ETOR-507(under GNR-011) |
| First Submitted: | December 21, 2007 |
| First Posted: | January 2, 2008 |
| Results First Submitted: | August 18, 2009 |
| Results First Posted: | September 28, 2009 |
| Last Update Posted: | May 21, 2015 |