Ocular Comfort Clinical Trial
Official title:
Ocular Comfort and OCT Observation of Post Lens Clearance and Ocular Tissue Compression
Verified date | November 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 study was to compare the fit and comfort of two types of contact lenses.
Status | Completed |
Enrollment | 20 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Be of legal age of consent and sign Informed Consent document. - Normal binocularity. - Be able to wear soft contact lenses. - Willing to comply with the wear and study visit schedule. - Spherical contact lens prescription within 0.50 diopter of the available lens powers. - Spectacle cylinder less than or equal to 1.50 diopter. - Other protocol-defined inclusion criteria may apply. Exclusion Criteria: - Eye injury or surgery within twelve weeks of enrollment. - Pre-existing ocular irritation that would preclude contact lens fitting. - Currently enrolled in any clinical trial. - Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions as determined by the investigator. - Other protocol-defined exclusion criteria may apply. |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)
Country | Name | City | State |
---|---|---|---|
United States | McKnight Building, Bascom Palmer Eye Institute | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
CIBA VISION | Bascom Palmer Eye Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Final Comfort | Comfort was assessed by the participant on a Visual Analog Scale of 0 to 100, where 0=Extremely Uncomfortable ("My eyes are in pain. I cannot tolerate my lenses") and 100=Extremely Comfortable ("My eyes feel GREAT, better than normal. I cannot feel my lenses"). | Day 2, Hour 10 | No |
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