Clinical Biocompatibility Evaluation of Contact Lens Coatings
Completed · Not applicable
Conditions studied: Refractive Errors, Ametropia
In brief
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.
Key facts
- Study ID
- NCT03034928
- Run by
- Alcon Research
- People needed
- 33
- Starts
- 2017-02-14
- Expected to finish
- 2017-03-14
- Last updated by the study team
- 2020-02-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Alcon Investigative Site — Johns Creek, Georgia, United States
Full record on ClinicalTrials.gov
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