N/A
N=33
Clinical Biocompatibility Evaluation of Contact Lens Coatings
Refractive Errors · Ametropia
Bottom Line
View on ClinicalTrials.gov: NCT03034928 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Average Percent Area of Solution-related Corneal Staining — 7.01; 12.82; 13.54; 7.58 percentage of area
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Contact lens with investigational coating 1 (Device); Balafilcon A contact lens (Device); OPTI-FREE® RepleniSH® MPDS (Device); Contact lens with investigational coating 2 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Percent Area of Solution-related Corneal Staining |
7.01; 12.82; 13.54; 7.58 | — |
Summary
The primary objective is to evaluate corneal staining observed after 2 hours of wear with contact lenses with investigational coating against PureVision™ lenses, all pre-cycled with OPTI-FREE® RepleniSH® multi-purpose disinfection solution.
Eligibility Criteria
Inclusion Criteria
- Able to understand and must sign an Informed Consent;
- Successful wearer of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
- Manifest cylinder less than or equal to 1.50 diopter (D) in each eye;
- Best Corrected Visual Acuity (BCVA) 20/25 or better in each eye;
- VA with habitual spectacles 20/40 in both eyes (OU) or better and willing to wear spectacles as needed during the washout period and during study lens exposure;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Any anterior segment infection, inflammation, abnormality or disease that contraindicates contact lens wear;
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
- History of refractive surgery or plan to have refractive surgery during the study or irregular cornea in either eye;
- Ocular or intra-ocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
- Current or history of pathologically dry eye in either eye that would preclude contact lens wear;
- Current or history of herpetic keratitis in either eye;
- Eye injury in either eye within 12 weeks immediately prior to enrollment;
- History of intolerance or hypersensitivity to any component of the study lenses or solutions;
- Habitual contact lenses worn in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
- Use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03034928). 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.