Myopia Clinical Trial
Verified date | January 2012 |
Source | Alcon Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this trial is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of 5 different daily disposable contact lenses.
Status | Completed |
Enrollment | 128 |
Est. completion date | September 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Currently wear spherical, soft contact lenses replaced at intervals of 2 weeks or monthly. - Habitually wear lenses for at least 8 hours per day, 4 days per week, for at least the past 6 months. - Report 2 or more qualifying symptoms with current contact lenses with a frequency of "frequently" or "all the time" - Able to achieve VA of at least 20/40 in each eye with habitual correction and with study lenses at dispense. - Other protocol inclusion/exclusion criteria may apply. Exclusion Criteria: - Eye injury or surgery within twelve weeks immediately prior to enrollment. - Currently enrolled in any clinical trial. - Any use of medications for which contact lens wear could be contraindicated as determined by the investigator. - History of corneal refractive surgery. - Cylinder correction greater than 1.00 D. - Current monovision contact lens wearers. - Other protocol inclusion/exclusion criteria may apply. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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CIBA VISION |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lens Awareness | Lens awareness, as interpreted by the subject, was reported by the subject as a single, retrospective evaluation of 4 week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being all the time. Four-week ratings were compared to baseline ratings, and a negative difference (4-week minus baseline) represented an improvement. | 4 weeks of wear | No |
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