Clinical Biocompatibility Evaluation of Contact Lens Coatings

Launched by ALCON RESEARCH · Jan 25, 2017

Keywords

ClinConnect Summary

In this contralateral crossover study, qualifying subjects will wear a total of 2 pairs of study contact lenses. Lenses will be worn according to a randomized lens sequence assignment. Each pair will consist of a test lens (Test 1 or Test 2) and a control lens.

Gender

ALL

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.