Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 2
Status: | Not yet recruiting |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/30/2019 |
Start Date: | April 2019 |
End Date: | July 2019 |
Contact: | Alcon Call Center |
Email: | alcon.medinfo@alcon.com |
Phone: | 1-888-451-3937 |
The purpose of this study is to evaluate visual acuity at distance when wearing DDT2 contact
lenses compared to Clariti contact lenses.
lenses compared to Clariti contact lenses.
Subjects will be expected to attend 3 study visits and wear study lenses for approximately 14
- 20 days (7 - 10 days for each product).
- 20 days (7 - 10 days for each product).
Inclusion Criteria:
- Able to understand and sign an Informed Consent Form that has been approved by an
Institutional Review Board.
- Willing and able to attend all scheduled study visits as required per protocol.
- Successful wear of spherical soft contact lenses for distance correction in both eyes
during the past 3 months for a minimum of 5 days per week and 8 hours per day.
- Manifest cylinder of ≤ 0.75 diopter (D) in each eye.
- Best corrected visual acuity (VA) of 20/25 or better in each eye.
- Able to wear contact lenses within a range of sphere power from -1.00 to -6.00 D (0.25
D steps) and VA of 20/25 or better in each eye with fitting set lenses.
Exclusion Criteria:
- Any anterior segment infection, inflammation, or abnormality or disease (including
systemic) that contraindicates contact lens wear.
- Any use of systemic or ocular medications for which contact lens wear could be
contraindicated.
- History of ocular or intraocular surgery, including refractive surgery and/or
irregular cornea.
- Biomicroscopy findings at baseline that are moderate (grade 3) or higher and/or
corneal vascularization that is mild (grade-2) or higher.
- Current or history of pathologically dry eye in either eye that would preclude contact
lens wear.
- Eye injury in either eye within 12 weeks immediately prior to enrollment for this
trial.
- Wearing habitual contact lenses in an extended wear modality (routinely sleeping in
lenses for at least 1 night per week) over the last 3 months prior to enrollment.
- Any use of topical ocular medications and artificial tear or rewetting drops that
would require instillation during contact lens wear.
- Previous or current habitual wearer of clariti® or DAILIES TOTAL1® contact lenses.
Other protocol-specified criteria may apply.
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