An interventional study of Bausch & Lomb Test lens and Ciba Vision soft contact lens in Myopia, sponsored by Bausch & Lomb Incorporated. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-29.
Sponsored by Bausch & Lomb Incorporated · Not applicable, Interventional, and Screening
The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lenses developed by Bausch + Lomb.
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's enrollment of 100 is above the median of 80 across 783 interventional studies indexed under Myopia.
Browse Myopia studies →Bausch & Lomb Incorporated is the lead sponsor of 219 studies on the registry; 7 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 41 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bausch + Lomb investigational soft contact lens
Device: Bausch & Lomb Test lens
Ciba Vision Air Optix Aqua soft contact lens
Device: Ciba Vision soft contact lens
Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses.
Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses.
Visual Acuity
The mean difference in high contrast logMAR, over all lens visual acuities (VAs) between lens groups.
Time frame: One week
Overall Comfort
The mean difference in comfort-related symptoms/complaints scores between lens groups. Rated on a scale of 0-100 with 100 being the most favorable score.
Time frame: One week
This study was conducted at 5 clinical sites in the US. First participant was enrolled 08/08/2011 and last participant exited on 09/01/2011.
| Milestone | Bausch+Lomb Test Lens Then Ciba Vision Lens | Ciba Vision Soft Contact Lens Then Bausch+Lomb Test Lens |
|---|---|---|
| Started | 50 | 50 |
| Completed | 50 | 46 |
| Not completed | 0 | 4 |
| Withdrew: Ineligible | 0 | 1 |
| Withdrew: Positive slit lamp finding | 0 | 1 |
| Withdrew: Unacceptable lens movement | 0 | 1 |
| Withdrew: Inability to maintain wear | 0 | 1 |
| Milestone | Bausch+Lomb Test Lens Then Ciba Vision Lens | Ciba Vision Soft Contact Lens Then Bausch+Lomb Test Lens |
|---|---|---|
| Started | 50 | 46 |
| Completed | 50 | 46 |
| Not completed | 0 | 0 |
The mean difference in high contrast logMAR, over all lens visual acuities (VAs) between lens groups.
| LogMAR | Bausch+Lomb Test Lens | Ciba Vision Soft Contact Lens |
|---|---|---|
| Visual Acuity | -0.054 ± 0.115 | -0.051 ± 0.115 |
The mean difference in comfort-related symptoms/complaints scores between lens groups. Rated on a scale of 0-100 with 100 being the most favorable score.
| units on a scale | Bausch + Lomb Test Lens | Ciba Vision Soft Contact Lens |
|---|---|---|
| Overall Comfort | 81.9 ± 21.7 | 82.7 ± 21.8 |
Collected over 1 week. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bausch & Lomb Test Lens | — | 0/99 (0%) | 0/99 (0%) |
| Ciba Vision Soft Contact Lens | — | 0/99 (0%) | 0/99 (0%) |
All participants enrolled in the study
| Age, Continuous(years) | Overall Study |
|---|---|
| Mean | 29.9 ± 7.6 |
| Sex: Female, Male(Participants) | Overall Study |
|---|---|
| Female | 67 |
| Male | 32 |
| Race (NIH/OMB)(Participants) | Overall Study |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 94 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Overall Study |
|---|---|
| United States | 99 |
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Bausch & Lomb Incorporated