Keratoconus
Conditions
Brief summary
The objective of this twelve month dispensing study is to evaluate the clinical performance, particularly comfort and vision, of KeraSoft IC Soft Contact Lenses.
Interventions
DEVICEKeraSoft IC Soft Contact Lenses
Lenses will be worn between 8 and 16 hrs each day, for 12 months
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have participated and completed a previous study (ROC2-10-078). * Is Keratoconic
Exclusion criteria
* Has any systemic disease affecting ocular health. * Is using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance. * Is not correctable to 20/50 or better in each eye with contact lenses. * Has greater than Grade 2 slit lamp exam findings. * Has any atypical scar for a keratoconic or neovascularization within the central 4mm of the cornea. Subjects with minor peripheral corneal scarring that, in the Investigator's judgment, does not interfere with contact lens wear are eligible for this study. * Has any neovascularization within the central 4mm of the cornea.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort | 4 visits over 1 year | Symptoms and complaints measured on an analog scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity - Low Contrast | 4 visits over 1 year | Low contrast visual acuity measured with high ambient illumination (LCHI) |
| Visual Acuity - High Contrast | 4 visits over 1 year | High contrast visual acuity measured with high ambient illumination (HCHI) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| KeraSoft IC Soft Contact Lenses KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care
KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Study related complaints | 1 |
| Overall Study | Unacceptable distance visual acuity | 2 |
Baseline characteristics
| Characteristic | KeraSoft IC Soft Contact Lenses |
|---|---|
| Age, Continuous | 48 years |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Comfort
Symptoms and complaints measured on an analog scale
Time frame: 4 visits over 1 year
Population: DUE TO THE CANCELLATION OF THIS PROJECT, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS WERE MADE.
Secondary
Visual Acuity - High Contrast
High contrast visual acuity measured with high ambient illumination (HCHI)
Time frame: 4 visits over 1 year
Population: DUE TO THE CANCELLATION OF THIS PROJECT, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS WERE MADE.
Secondary
Visual Acuity - Low Contrast
Low contrast visual acuity measured with high ambient illumination (LCHI)
Time frame: 4 visits over 1 year
Population: DUE TO THE CANCELLATION OF THIS PROJECT, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS WERE MADE.