A Safety and Effectiveness Study of a New Multi-Purpose Contact Lens Care Solution
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/13/2019 |
Start Date: | April 23, 2018 |
End Date: | October 30, 2018 |
Clinical Safety and Effectiveness of ASP-57 Multi-Purpose Contact Lens Care Solution Compared to a Marketed Contact Lens Solution
The objective of this study is to evaluate the safety and effectiveness of ASP-57
Multi-Purpose contact lens solution (Test) compared to ReNu® Multiplus Contact Lens Solution
(Control) when used by habitual contact lens wearers to bilaterally clean and disinfect their
contact lenses for approximately 3 months (12 weeks).
Multi-Purpose contact lens solution (Test) compared to ReNu® Multiplus Contact Lens Solution
(Control) when used by habitual contact lens wearers to bilaterally clean and disinfect their
contact lenses for approximately 3 months (12 weeks).
Approximately 330 subjects (660 eyes) will be enrolled in this 3 month (12 week) controlled,
parallel group, masked, randomized study at approximately 15 investigative sites in the
United States. Subjects will be randomized 2:1 to receive either Asepticys ASP-57
Multi-Purpose Solution or ReNu® Multiplus Contact Lens Solution (Control) respectively. Both
Test and Control solution will be used with a rub care regimen.
parallel group, masked, randomized study at approximately 15 investigative sites in the
United States. Subjects will be randomized 2:1 to receive either Asepticys ASP-57
Multi-Purpose Solution or ReNu® Multiplus Contact Lens Solution (Control) respectively. Both
Test and Control solution will be used with a rub care regimen.
Inclusion Criteria:
1. Subjects age ≥ 18 years on the date of informed consent.
2. All subjects must provide signed written consent prior to participation in any study
related procedures.
3. Successful history of wear of the one of the following lens types (toric and
multifocal lenses of the specified lens type are allowed) in both eyes during the past
3 months, and history of at least 5 consecutive days of successful daily wear in both
eyes prior to Visit 1:
- All Bausch & Lomb PureVision lens types
- All Alcon Air Optix lens types
- All CooperVision Biofinity lens types
- All Vistakon Acuvue Oasys lens types
- Any conventional hydrogel Group IV lens
4. Vision correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or
better (distance, high contrast) in each eye.
5. Clear central corneas and free of any anterior segment disorders
6. Habitual use of a Multi-Purpose Solution for cleaning, disinfecting, and storage of
lenses.
7. Lens correction in both eyes is required and the same brand of lens is worn in each
eye.
8. Agree to wear study lenses in both eyes on a daily wear basis, with lenses removed
every night (not slept in) throughout the study period and no lens or pair of lenses
worn for longer than 2 weeks.
9. Able and willing to comply with all care regimen and follow-up study procedures.
Exclusion Criteria:
1. Females of childbearing potential (not surgically sterilized or postmenopausal) if any
one of the following conditions are met:
- currently pregnant,
- plan to become pregnant during the study,
- are breast-feeding.
2. Wear of gas permeable contact lenses within the last 30 days.
3. Wear of polymethylmethacrylate lenses within the last 3 months.
4. No topical ocular prescription medications may be administered during the study
period. Ongoing use of non-preserved artificial tears up to 4 times daily (with no
changes in frequency or brand) is allowed. Ongoing use of the rewetting drop the
subject customarily uses (with no switch in brand or type) is also permitted during
the study period.
5. Current systemic disease affecting ocular health or use of topical or systemic
medications that, in the Investigator's opinion, could affect ocular physiology or
lens performance.
6. Ocular astigmatism of 2.00 D or greater in either eye based on the contact lens
prescription.
7. Grade 2 or greater finding on any slit-lamp scale and/or corneal infiltrates of any
grade during slit-lamp examination at Screening.
8. Any finding during slit-lamp examination that, in the Investigator's opinion,
interferes with contact lens wear.
9. Scar or neovascularization within the central 4 millimeters (mm) of the cornea. Minor
peripheral corneal scarring (that does not extend into the central zone) is permitted,
if in the Investigator's judgment, it does not interfere with contact lens wear.
10. Aphakia.
11. Amblyopia.
12. History of any corneal surgery.
13. Allergy to any component of the study solutions.
14. Participation in any clinical study within the 2 weeks prior to entry into this study.
We found this trial at
14
sites
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