An interventional study of KeraSoft IC Soft Contact Lenses in Keratoconus, sponsored by Bausch & Lomb Incorporated. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-25.
Sponsored by Bausch & Lomb Incorporated · Not applicable, Interventional, and Supportive care
The objective of this twelve month dispensing study is to evaluate the clinical performance, particularly comfort and vision, of KeraSoft IC Soft Contact Lenses.
307 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's enrollment of 12 is below the median of 40 across 203 interventional studies indexed under Keratoconus.
Browse Keratoconus 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:
KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care
Device: KeraSoft IC Soft Contact Lenses
Lenses will be worn between 8 and 16 hrs each day, for 12 months
Comfort
Symptoms and complaints measured on an analog scale
Time frame: 4 visits over 1 year
Visual Acuity - Low Contrast
Low contrast visual acuity measured with high ambient illumination (LCHI)
Time frame: 4 visits over 1 year
Visual Acuity - High Contrast
High contrast visual acuity measured with high ambient illumination (HCHI)
Time frame: 4 visits over 1 year
| Milestone | KeraSoft IC Soft Contact Lenses |
|---|---|
| Started | 12 |
| Completed | 8 |
| Not completed | 4 |
| Withdrew: Unacceptable distance visual acuity | 2 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Study related complaints | 1 |
Symptoms and complaints measured on an analog scale
No measurements were reported for this outcome.
Low contrast visual acuity measured with high ambient illumination (LCHI)
No measurements were reported for this outcome.
High contrast visual acuity measured with high ambient illumination (HCHI)
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| KeraSoft IC Soft Contact Lenses | — | 0/12 (0%) | 0/12 (0%) |
| Age, Continuous(years) | KeraSoft IC Soft Contact Lenses |
|---|---|
| Mean | 48 (33 to 63) |
| Sex: Female, Male(Participants) | KeraSoft IC Soft Contact Lenses |
|---|---|
| Female | 5 |
| Male | 7 |
This study is terminated, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Bausch & Lomb Incorporated