N/A
N=42
Comparison of a New Abbott Medical Optics (AMO) Multi-Purpose Solution (MPS) to Existing Contact Lens Regimens
Normal Contact Lens Wearers
Bottom Line
View on ClinicalTrials.gov: NCT01294917 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
May 2012
Primary outcome: Primary: Corneal Staining — 184; 46.6; 77.8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Multi-purpose disinfecting solution (Device); Clear Care (Device); Opti-Free RepleniSH (Device)
- Age
- Pediatric, Adult, Older Adult · 17+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Optics
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Corneal Staining |
184; 46.6; 77.8 | — |
| SECONDARY Subjective Lens Wearing Comfort |
— | — |
| SECONDARY Dryness |
— | — |
Summary
Crossover clinical evaluation three contact lens care regimens used for one month with Acuvue Oasys lenses.
Eligibility Criteria
Inclusion Criteria
- Is at least 17 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Has had an ocular examination in the last two years;
- Is a current soft lens wearer using either two-week or monthly replacement lenses;
- Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction (either spectacles or contact lenses);
- Has normal binocular vision (no strabismus, no amblyopia);
- Has clear corneas and no active ocular disease;
- Has a distance contact lens prescription between +8.00 diopters (D) to -12.00 D and a successful fit with the study lenses;
- Has astigmatism less than or equal to -1.00 D;
- Agrees to wear the study lenses on a daily wear basis.
Exclusion Criteria
- Has any active ocular disease;
- Has any clinically significant lid, conjunctival, or corneal abnormalities that may affect a study outcome variable;
- Has undergone corneal refractive surgery;
- Has a systemic condition that may affect a study outcome variable;
- Is using any systemic or topical medications that may affect ocular health;
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Is pregnant or lactating;
- Is participating in any other clinical or research study that may affect a study outcome variable;
- Currently wears daily disposable lenses or extended wear lenses.
Data sourced from ClinicalTrials.gov (NCT01294917). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.