N/A
N=78
Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues
Contact Lens Care
Bottom Line
View on ClinicalTrials.gov: NCT01494818 ↗Enrolled (actual)
78
Serious AEs
2.6%
Results posted
Sep 2013
Primary outcome: Primary: Maximum Papillae — 2.0; 2.0; 2.0; 2.0 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hydrogen peroxide-based contact lens care system (Device); PHMB-containing contact lens solution (Device); Soft contact lenses (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Papillae |
2.0; 2.0; 2.0; 2.0 | — |
| PRIMARY Maximum Eyelid Hyperaemia |
2.0; 2.0; 2.0; 2.0 | — |
| PRIMARY Upper Lid Redness |
34.8; 34.9; 35.2; 35.4 | — |
| PRIMARY Change From Baseline in Upper Eyelid Margin Staining at Month 3 |
-0.014; -0.754 | — |
| SECONDARY Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT) |
4.05; 5.08; 5.76; 4.22 | — |
| SECONDARY Protective Index |
95.9; 95.8; 96.4; 97.8 | — |
| SECONDARY Median Front Lens Deposits |
0; 0; 0; 0 | — |
| SECONDARY Total Lipid Uptake Per Lens |
38.95; 36.44; 32.40; 34.20 | — |
Summary
The purpose of this study was to assess and compare the effect of the repeated usage of two different contact lens care systems (one hydrogen peroxide-based cleaning and disinfecting system, and one polyaminopropyl biguanide (PHMB)-containing multipurpose system) with silicone hydrogel contact lenses worn on a daily wear basis for three months. The specific aspect of interest was the effect on the ocular tissue, in particular the eyelids and their associations with the contact lens surface wettability and surface contamination.
Eligibility Criteria
Inclusion Criteria
- Read and understand Participant Information Sheet;
- Read, sign, and date Informed Consent;
- Successfully wearing silicone hydrogel contact lenses under a frequent replacement (biweekly or monthly) daily wear modality;
- Using a PHMB-containing multipurpose contact lens solution;
- Symptomatic, as specified in protocol;
- Best corrected visual acuity of 6/9 or better in each eye;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Any known sensitivity or intolerance to the contact lenses or len care products to be used;
- Systemic disease/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;
- Use of any concomitant topical ocular medications during the study period;
- Participation in an investigational drug or device study within 30 days of entering the study;
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01494818). 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.