NCT02727816

Non-dispensing Fitting Study Comparing the Clinical Performance Hydrogel Sphere Design Contact Lenses.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: CooperVision, Inc. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The aim of this non-dispensing study is to evaluate the clinical performance of different hydrogel contact lens designs.

Detailed description

This is a 35-subject, double masked, randomized, contra lateral, non-dispensing fitting trial comparing different hydrogel lens materials. For each study, this study will involve 2 visits: lens dispensing (baseline) and 1 hour post lens settling. Each subject will be randomized to wear the test and control lenses, in the right or left eye, in a series of four short fitting comparisons as follows: Pair 1 (P1): filcon IV I (Base Curve (BC) 8.6) and ocufilcon D Pair 2 (P2): filcon IV I (Base Curve (BC) 8.7) and ocufilcon D Pair 3 (P3): methafilcon A (Base Curve (BC) 8.6) and ocufilcon D Pair 4 (P4): methafilcon A (Base Curve (BC)8.7) and somofilcon A

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	filcon IV I (BC 8.6)	control lens
DEVICE	filcon IV I (BC 8.7)	control lens
DEVICE	ocufilcon D	test lens
DEVICE	methafilcon A (BC 8.6)	control lens
DEVICE	methafilcon A (BC 8.7)	control lens
DEVICE	somofilcon A	test lens

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-05-01
• Completion: 2016-08-01
• First posted: 2016-04-05
• Last updated: 2018-02-06
• Results posted: 2018-02-06

Locations

1 site across 1 country: Mexico