N/A
Completed N=90
Clinical Evaluation of the Safety and Efficacy of FID 120947A
Refractive Error
Source: ClinicalTrials.gov NCT02771145 ↗
Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Percentage of Eyes With Visibly Clean Lenses at Each Visit — 92.2; 88.2; 95.5; 92.5 percentage of eyes
Summary
The purpose of this study is to evaluate the safety and efficacy of FID 120947A in soft contact lens wearers of Japanese ethnicity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Eyes With Visibly Clean Lenses at Each Visit |
92.2; 88.2; 95.5; 92.5; 95.2; 95.9 | — |
| PRIMARY Number of Eyes With Film Deposits on Lens by Type at Each Visit |
0; 3; 1; 3; 0; 4 | — |
| PRIMARY Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit |
4; 8; 2; 5; 4; 8 | — |
| PRIMARY Percentage of Lens Area Covered by Film Deposits at Each Visit |
7.5; 28.6; 17.5; 15.0; 6.0; 7.5 | — |
| PRIMARY Percentage of Lens Area Covered by Crystalline Deposits at Each Visit |
10.4; 10.8; 8.8; 7.1; 11.7; 13.0 | — |
| PRIMARY Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit |
0.6; 0.6; 6.2; 90.4; 1.7; 0.6 | — |
| PRIMARY Average Lens Wear Time (Averaged Over the Last 3 Days) at Each Visit |
12.4; 11.9; 12.0; 11.8; 11.7; 11.9 | — |
| PRIMARY Lens Wear Time at Each Visit Day |
4.3; 4.8; 4.7; 4.2; 4.4; 4.4 | — |
| PRIMARY Average Rewetting Drop Frequency at Each Visit |
0.3; 1.4; 1.7; 1.6; 1.7; 1.8 | — |
| PRIMARY Number of Unscheduled Lens Replacements by Reason |
5; 38; 17; 4; 0; 0 | — |
| PRIMARY Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day." |
26.7; 44.4; 22.2; 6.7; 0.0; 35.6 | — |
| PRIMARY Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear." |
42.2; 38.9; 12.2; 5.6; 1.1; 48.9 | — |
| PRIMARY Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling." |
44.4; 41.1; 12.2; 2.2; 0.0; 28.9 | — |
Eligibility Criteria
Inclusion Criteria
- Successful history of silicone hydrogel or other soft contact lens wear (except for daily disposable lenses) in both eyes during the past 3 months and history of at least 5 consecutive days of successful DAILY wear in both eyes at Visit 1;
- Best spectacle corrected distance visual acuity greater than or equal to 0.8 (decimal visual acuity) in each eye;
- Other protocol-specified 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;
- Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- Use of a daily cleaner and/or enzyme cleaner to care for lenses at least 7 days prior to Visit 1 (use of lens rewetting drops is acceptable);
- History of intolerance or hypersensitivity to any component of the investigational products;
- Unwilling or unable to abstain from use of all over-the-counter (OTC) or prescribed topical ocular medications (except for rewetting drops) within 7 days prior to Visit 1 and for the duration of the study;
- Moderate (grade 3) or severe (grade 4) corneal edema, corneal staining, injection (limbal hyperemia, bulbar conjunctival hyperemia), tarsal abnormalities, or "other" findings;
- Corneal vascularization that is mild (grade 2) or higher;
- Conjunctival or structural lid abnormalities or abnormal corneal opacities at Visit 1;
- Current or history of ocular infection, severe inflammation or disease within 6 months prior to Visit 1;
- Any systemic disease (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 for a minimum of 30 days prior to Visit 1;
- Ocular or intra-ocular surgery and/or ocular trauma within the last 12 months (excluding placement of punctal plugs);
- Participation in any investigational clinical study within 30 days of Visit 1;
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02771145). 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. Informational only — not medical advice.