N/A
N=79
An Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT01594294 ↗Enrolled (actual)
79
Serious AEs
5.1%
Results posted
Jul 2014
Primary outcome: Primary: Maximum Papillae — 1.50; 1.00; 1.50; 1.00 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AOSEPT® Plus contact lens solution (Device); ReNu MultiPlus® contact lens solution (Device); Etafilcon A contact lenses (Device); Lotrafilcon B contact lenses (Device); COMPLETE® MPS Easy Rub® Formula contact lens solution (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Papillae |
1.50; 1.00; 1.50; 1.00 | — |
| PRIMARY Maximum Eyelid Hyperaemia |
2.00; 2.00; 2.00; 2.00 | — |
| PRIMARY Mean Upper Eyelid Redness |
34.7; 31.9; 33.4; 30.8 | — |
| PRIMARY Mean Upper Eyelid Margin Staining |
5.36; 4.33; 4.49; 4.80 | — |
| SECONDARY Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT) |
4.16; 4.52 | — |
Summary
The purpose of this study was to assess and compare the effect of the repeated usage of 2 different care systems (one hydrogen peroxide based cleaning and disinfecting system and one PHMB containing multipurpose system) with ACUVUE® 2® and AIR OPTIX® AQUA contact lenses worn on a daily wear basis for a 3-month period.
Eligibility Criteria
Inclusion Criteria
- Read and understand the Participant Information Sheet;
- Read, sign, and date an Informed Consent;
- Successfully wearing a frequent replacement hydrogel or silicone hydrogel contact lens brand under a frequent replacement (biweekly or monthly) daily wear modality;
- Classified as symptomatic according to protocol-specified criteria;
- Agree to wear study contact lenses as directed for the duration of the study;
- Best corrected visual acuity (BCVA) of 6/9 or better in each eye;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Any known sensitivity or intolerance to any of the contact lenses or contact lens care products to be used;
- Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses);
- History of seasonal allergies, which may have an adverse impact on contact lens wear, or data and information obtained in this study;
- Systemic disease or use of medication which might interfere with contact lens wear or produce dry eye side effects;
- Ocular allergies or ocular disease which might interfere with contact lens wear or data and information obtained in this study;
- Active ocular infection;
- Use of any concomitant topical ocular medications during the study period;
- Significant ocular anomaly;
- Previous ocular surgery;
- History of recent, significant changes in visual acuity;
- Any medical condition that might be prejudicial to the study;
- Pregnant, planning to be become pregnant, or lactating at time of enrollment;
- Any infectious disease (e.g. hepatitis, tuberculosis), immunosuppressive disease (e.g. HIV), or diabetes;
- Participation in an investigational drug or device study within 30 days of entering study;
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01594294). 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.