Comparison of New Contact Lens With Current Marketed Lens

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Phoebe test lens; Device: stenfilcon A lens (control)

• Registration Number: NCT03360110
• Lead Sponsor: Coopervision, Inc.

Brief Summary

The purpose of this study is to validate the clinical performance of a new contact lens design.

Detailed Description

Evaluate the clinical performance of its Phoebe contact lenses (Test) compared to the commercially available MyDay contact lenses (Control).

Study Timeline

• Study Start: 2017-11-06
• Study First Submitted: 2017-11-21
• Study First Submitted QC: 2017-11-27
• Study First Posted: 2017-12-02
• Primary Completion: 2017-12-15
• Study Completion: 2017-12-15
• Disposition First Submitted: 2019-06-03
• Status Verified: 2020-08
• Results First Submitted: 2020-08-04
• Results First Submitted QC: 2020-08-18
• Disposition First Submitted QC: 2020-08-18
• Last Update Submitted: 2020-08-18
• Results First Posted: 2020-09-02
• Disposition First Posted: 2020-09-02
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test lens	Phoebe test lens	Subjects randomized to wear pair of test lens either first or second
Test lens	stenfilcon A lens (control)	Subjects randomized to wear pair of test lens either first or second
stenfilcon A lens (control)	Phoebe test lens	Subjects randomized to wear pair of control lens either first or second
stenfilcon A lens (control)	stenfilcon A lens (control)	Subjects randomized to wear pair of control lens either first or second

Primary Outcome Measures

Name	Time	Method
Corneal Staining Extent	Day 3	Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a scale 0-4 (0=no staining, 1 = 1-15% of area, 2= 16-30% of area, 3=31-45% of area, 4=\>45% of area).
Palpebral Hyperemia on Upper Lid	Day 3	Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Palpebral Roughness Grade - Upper Lid	Day 3	Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Conjunctival Staining Score	Day 3	Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps
Palpebral Hyperemia on Lower Lid	Day 3	Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Palpebral Roughness Grade - Lower Lid	Day 3	Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps

Secondary Outcome Measures

Name	Time	Method
Distance Visual Acuity	Day 3	Distance visual acuity recorded in logMAR.
Near Visual Acuity	Day 3	Near visual acuity recorded in logMAR
Vision Quality Rating	Day 3	Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent)

Trial Locations

Locations (1)

Clinical Optical Research Lab (CORL); 🇺🇸 Bloomington, Indiana, United States