Comparison of New Contact Lens With Current Marketed Lens

Myopia Clinical Trial

Official title:

Clinical Validation Study of Phoebe Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03360110
• Other study ID #: CV-17-60
• Status: Completed
• Phase: N/A
• Start date: November 6, 2017
• Est. completion date: December 15, 2017

Study information

• Verified date: August 2020
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 15, 2017
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion criteria

A person is eligible for inclusion in the study if he/she:

• Between and 18 and 35 years of age and has full legal capacity to volunteer

• Has had a self-reported oculo-visual examination in the last two years

• Has read and understood the information consent letter

• Is willing and able to follow instructions and maintain the appointment schedule

• Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected

• Has a Contact Lens Refraction between -1.00D and -6.00D

• Cylinder power = -0.75DC in Spherical Cylindrical Refraction

• Currently wears soft contact lenses

• Is willing to wear lenses for a minimal of 8 hours a day and everyday during the course of the study

• Has clear corneas and no active ocular disease

• Has not worn lenses for at least 12 hours before the first visit

Exclusion Criteria

A person will be excluded from the study if he/she:

• Has never worn contact lenses before

• Is wearing Monovision modality

• Has any systemic disease affecting ocular health

• Is using any systemic or topical medications that will affect ocular health

• Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses

• Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye

• Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars

• Is aphakic

• Has undergone corneal refractive surgery

• Is participating in any other type of eye related clinical or research study

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Phoebe test lens
Daily disposable contact lens
• stenfilcon A lens (control)
Daily disposable contact lens

Locations

Country	Name	City	State
United States	Clinical Optical Research Lab (CORL)	Bloomington	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal Staining Extent	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).	Baseline
Primary	Corneal Staining Extent	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).	Day 3
Primary	Conjunctival Staining Score	Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps	Baseline
Primary	Conjunctival Staining Score	Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps	Day 3
Primary	Palpebral Hyperemia on Upper Lid	Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps	Baseline
Primary	Palpebral Hyperemia on Upper Lid	Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps	Day 3
Primary	Palpebral Hyperemia on Lower Lid	Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps	Baseline
Primary	Palpebral Hyperemia on Lower Lid	Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps	Day 3
Primary	Palpebral Roughness Grade - Upper Lid	Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps	Baseline
Primary	Palpebral Roughness Grade - Upper Lid	Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps	Day 3
Primary	Palpebral Roughness Grade - Lower Lid	Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps	Baseline
Primary	Palpebral Roughness Grade - Lower Lid	Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps	Day 3
Secondary	Distance Visual Acuity	Distance visual acuity recorded in logMAR.	Baseline (at lens dispense)
Secondary	Distance Visual Acuity	Distance visual acuity recorded in logMAR.	Day 3
Secondary	Near Visual Acuity	Near visual acuity recorded in logMAR	Baseline (at dispense)
Secondary	Near Visual Acuity	Near visual acuity recorded in logMAR	Day 3
Secondary	Vision Quality Rating	Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent)	Baseline (at dispense)
Secondary	Vision Quality Rating	Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent)	Day 3