NCT02131402

Clinical Performance of Hydrogel vs. Silicone Hydrogel Contact Lenses

Non-Dispensing Fitting Study Comparing the Clinical Performance of Hydrogel vs. Silicone Hydrogel Sphere Design Contact Lenses

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: CooperVision, Inc. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The aim of this non-dispensing fitting study is to evaluate the subjective comfort, lens handling, lens fitting characteristics and visual acuity of different hydrogel lens designs versus silicone hydrogel lenses

Detailed description

This is a 60-subject, double masked, randomized, contra lateral, non-dispensing fitting trial comparing different lens materials (hydrogel vs silicone hydrogel). It is anticipated that this study will involve 2 visits, for each lens pair, as follows: Visits: V1 (lens dispensing), V2 (1 hour post lens settling). Each subject will be randomized to wear the test and control lenses in a series of three short fitting comparisons.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	ocufilcon D	Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (ocufilcon D) in the contra lateral eye.
DEVICE	omafilcon A	Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A) in the contra lateral eye.
DEVICE	methafilcon A	Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (methafilcon A) in the contra lateral eye.

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-05-01
• Completion: 2014-06-01
• First posted: 2014-05-06
• Last updated: 2017-04-04
• Results posted: 2016-07-22

Locations

1 site across 1 country: Spain