Ametropia
Conditions
Brief summary
To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties.
Detailed description
To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties in a group of participants who present with lens related changes.
Interventions
DEVICESoft contact lens
Soft contact lens
Sponsors
CIBA VISION
University of Waterloo
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female, good health, age \>17yrs, able to wear contact lenses as primary vision correction, able to see well and achieve good fit with study lens, has understood & signed consent form.
Exclusion criteria
* Has active ocular disease, uses topical eye medication, wears gas permeable/silicone hydrogel /overnight wear contact lenses, is a participant in another clinical study, is deemed unsuitable for soft contact lens wear.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | baseline | level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision. |
| Neovascularisation | baseline | length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration. |
| Neovascularization | 9 month | length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration. |
Countries
Canada
Participant flow
Recruitment details
Participants recruited from local communities in Kitchener-Waterloo, Canada between July 2006 and Feb 2007
Pre-assignment details
38 participants recruited and screened; 4 withdrew by subject
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group soft lens wearers with sign of hypoxia and high prescription | 26 |
| Control Group normal non-lens wearers | 12 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | Control Group | Treatment Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 26 Participants | 38 Participants |
| Age Continuous | 33.25 years STANDARD_DEVIATION 6.9 | 31.6 years STANDARD_DEVIATION 10.75 | 32.4 years STANDARD_DEVIATION 9.9 |
| Region of Enrollment Canada | 12 participants | 26 participants | 38 participants |
| Sex: Female, Male Female | 8 Participants | 18 Participants | 26 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 26 | 0 / 12 |
| serious Total, serious adverse events | 0 / 26 | 0 / 12 |
Outcome results
Primary
Neovascularisation
length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Neovascularisation | 0.84 mm | Standard Deviation 0.39 |
| Control Group | Neovascularisation | 0.35 mm | Standard Deviation 0.16 |
Primary
Neovascularization
length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.
Time frame: 9 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Neovascularization | 0.63 mm | Standard Deviation 0.2 |
| Control Group | Neovascularization | 0.35 mm | Standard Deviation 0.19 |
Primary
Visual Acuity
level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.
Time frame: baseline
Population: Per Protocol. Only the data from participants who completed all study visits were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Visual Acuity | 0.01 logMAR | Standard Deviation 0.09 |
| Control Group | Visual Acuity | -0.07 logMAR | Standard Deviation 0.11 |
Primary
Visual Acuity
level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.
Time frame: 9 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Visual Acuity | 0.01 logMAR | Standard Deviation 0.09 |
| Control Group | Visual Acuity | -0.08 logMAR | Standard Deviation 0.1 |