A One-Week Crossover Dispensing Evaluation of New Daily Wear Soft Contact Lenses

Myopia Clinical Trial

Official title:

A One-Week Crossover Dispensing Evaluation of Gemini Daily Wear Soft Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03306641
• Other study ID #: CV-17-29
• Status: Completed
• Phase: N/A
• Start date: July 28, 2017
• Est. completion date: August 31, 2017

Study information

• Verified date: September 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 when worn over a period 1 week compared to nelfilcon A (control).

Description:

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 1 week compared to nelfilcon A (control). The primary outcomes of interest is lens fit acceptance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Is at least 18 years of age and has full legal capacity to volunteer.

• Is no greater than 55 years of age.

• Has read and understood the information consent letter.

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

• Is an adapted soft contact lens wearer having worn lenses for a minimum of 4 weeks prior to the study.

• Has spectacle cylinder =1.00D in both eyes.

• Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.

• Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye.

• Wears CLs in both eyes (monvision acceptable, but not monofit)

• Has clear corneas and no active ocular disease.

• Has not worn lenses for at least 12 hours before the examination.

• Is willing to wear the study contact lenses for a minimum 8 hours per day/6 days per week

Exclusion Criteria:

• Has never worn contact lenses before.

• 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 strabismus/amblyopia.

• Has undergone corneal refractive surgery.

• Is pregnant, lactating or planning a pregnancy.

• Is participating in any concurrent clinical or research study.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Test Contact Lens
Daily disposable contact lens
• Nelfilcon A
Focus Dailies All Day Comfort contact lens (nelfilcon A)

Locations

Country	Name	City	State
United States	Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University	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	Lens Fit Acceptance	Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)	Baseline
Primary	Lens Fit Acceptance	Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)	1-Week