An interventional study of Test, daily disposable contact lens and SofLens daily disposable contact lens in Myopia, sponsored by Bausch & Lomb Incorporated. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2014-01-08.
Sponsored by Bausch & Lomb Incorporated · Not applicable and Interventional
This study is to evaluate the safety and efficacy of a new hydrogel daily disposable contact lens compared to the Bausch + Lomb SofLens® daily disposable contact lens when worn by current soft contact lens wearers on a daily disposable wear basis.
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's enrollment of 173 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:
Test contact lens will be worn on a daily disposable wear basis.
Device: Test, daily disposable contact lens
The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.
Device: SofLens daily disposable contact lens
Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.
Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.
Slit Lamp Findings > Grade 2
Statistical non-inferiority of Slit Lamp Findings \> Grade 2 at any visit between the Test and Control lenses
Time frame: 4 visits over 3 months
High Contrast, Distance logMAR Visual Acuity (VA)
Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. For each eye, logMAR VA will be averaged over all follow-up visits as the primary endpoint
Time frame: 4 visits over 3 months
A total of 173 participants (346 eyes) were enrolled at 11 investigative sites in the United States (US), the first participant was enrolled in the study on 6/13/2011, the last participant exited the study on 10/1/2011.
| Milestone | SofLens Lens | Test Lens |
|---|---|---|
| Started | 86 | 87 |
| Completed | 85 | 87 |
| Not completed | 1 | 0 |
| Withdrew: Study related symptoms and complaints | 1 | 0 |
Statistical non-inferiority of Slit Lamp Findings \> Grade 2 at any visit between the Test and Control lenses
| eyes | SofLens Lens | Test Lens |
|---|---|---|
| Slit Lamp Findings > Grade 2 | 0 | 1 |
Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. For each eye, logMAR VA will be averaged over all follow-up visits as the primary endpoint
| logMAR | SofLens | Test Lens |
|---|---|---|
| High Contrast, Distance logMAR Visual Acuity (VA) | -0.028 ± 0.040 | -0.025 ± 0.040 |
Collected over 3 Months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SofLens Lens | — | 0/86 (0%) | 0/86 (0%) |
| Test Lens | — | 0/87 (0%) | 0/87 (0%) |
| Age, Customized(participants) | SofLens | Test Lens | Total |
|---|---|---|---|
| Between 18 and 40 years | 86 | 87 | 173 |
| Sex: Female, Male(Participants) | SofLens | Test Lens | Total |
|---|---|---|---|
| Female | 64 | 56 | 120 |
| Male | 22 | 31 | 53 |
| Region of Enrollment(participants) | SofLens | Test Lens | Total |
|---|---|---|---|
| United States | 86 | 87 | 173 |
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Bausch & Lomb Incorporated