N/A
N=352
Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Soft Contact Lens Wearers
Myopia · Astigmatism · Hyperopia · Refractive Error
Bottom Line
View on ClinicalTrials.gov: NCT01912768 ↗Enrolled (actual)
352
Serious AEs
0.1%
Results posted
Jun 2015
Primary outcome: Primary: Percentage of Subjects With Visibly Clean Lenses — 44.5; 39.8; 35.0; 31.3 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FID 120947A contact lens disinfecting solution (Device); renu fresh multi-purpose solution (Device); Soft contact lenses (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Visibly Clean Lenses |
44.5; 39.8; 35.0; 31.3; 40.5; 32.7 | — |
| PRIMARY Percentage of Subjects With Crystalline Deposits by Type |
63.6; 65.6; 25.5; 25.0; 10.9; 9.4 | — |
| PRIMARY Percentage of Subjects With Film Deposits by Type |
57.0; 58.9; 16.7; 19.6; 26.3; 21.4 | — |
| PRIMARY Average Residual Lens Lysozyme |
70.2; 114.5 | — |
| PRIMARY Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change |
0.0; 0.0; 0.4; 0.9; 97.0; 99.1 | — |
| PRIMARY Average Lens Wear Time |
12.9; 12.6; 12.9; 12.6; 13.0; 12.6 | — |
| PRIMARY Number of Unscheduled Lens Replacements by Reason |
3; 0; 4; 0; 2; 0 | — |
| PRIMARY Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day." |
30.1; 36.3; 55.1; 50.4; 5.1; 3.5 | — |
| PRIMARY Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear." |
30.5; 29.2; 57.2; 59.3; 6.4; 6.2 | — |
| PRIMARY Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling." |
31.4; 38.1; 52.1; 47.8; 10.2; 6.2 | — |
| PRIMARY Crystalline Deposit Area Covered |
12.5; 17.8; 12.1; 14.0; 13.0; 13.3 | — |
| PRIMARY Film Deposit Area Covered |
18.7; 16.7; 18.9; 20.5; 21.0; 23.4 | — |
Summary
The purpose of this study is demonstrate substantial equivalence of an investigational contact lens disinfecting solution to a commercially available contact lens solution in silicone hydrogel and soft contact lens wearers.
Eligibility Criteria
Inclusion Criteria
- Normal eyes (other than correction for visual acuity);
- Successful history of silicone hydrogel or soft contact lens wear in both eyes in one of the following brands: Soflens® 38, Proclear DW, Frequency 55, Acuvue® Oasys™, Air Optix Aqua, O2 OPTIX, Air Optix for Astigmatism, Air Optix Aqua Multifocal, Biofinity®, PureVision®, PureVision®2;
- Best spectacle corrected distance visual acuity greater than or equal to 20/25 in each eye;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the investigational products or affect the results of this study;
- Need to wear contact lenses on an extended wear basis (ie, overnight) during the study;
- Use of a daily cleaner and/or an enzyme cleaner to care for lenses at least 7 days prior to Visit 1;
- History of intolerance or hypersensitivity to any component of the investigational products;
- Use of all over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1;
- Moderate, severe, abnormal, or other ocular findings;
- Current or history of ocular infection, severe inflammation, or disease within 6 months prior to Visit 1;
- Any systemic disease at Visit 1 (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions;
- Use of systemic medications that may contribute to adverse ocular effects unless on a stable dosing regimen;
- Ocular surgery within the last 12 months;
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01912768). 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.