A Dispensing Comparison of a Test Daily 1 Day Lens Against a Control 1 Day Lens.

Myopia Clinical Trial

Official title:

A Dispensing Clinical Trial of Invigor 1 Daily Disposable Lens Against Clariti 1-day Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03951610
• Other study ID #: CV-19-01
• Status: Completed
• Phase: N/A
• Start date: February 21, 2019
• Est. completion date: June 4, 2019

Study information

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

Clinical Trial Summary

The purpose of this study is to compare the dispensing performance of somofilcon A test 1 day contact lens against somofilcon A control 1 day contact lens.

Description:

The purpose of this study is to evaluate the clinical performance of a silicone-hydrogel test contact lens compared to the commercially available silicone-hydrogel (control) contact lens when worn over one week for each lens type in a randomized, bilateral, cross-over, dispensing study on a daily disposable basis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 4, 2019
• Est. primary completion date: April 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

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

• 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 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.

• Currently wears soft contact lenses (average wearing of 8 hours/day and 5 days/week) without the need of using rewetting drops

• Requires spectacle lens spherical powers between -1.00 to -5.75 diopters sphere (0.25D steps).

• Has no more than 0.75 diopters of refractive astigmatism.

• Has clear corneas and no active ocular disease.

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

• Has a usable pair of spectacle lenses if required for transportation to the site for the initial visit

Exclusion Criteria:

• Is presently participating in any other clinical or research study including eye related clinical or research study.

• Has never worn contact lenses before.

• Has any systemic disease affecting ocular health.

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

• Is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health.

• Has any known sensitivity to fluorescein dye or products to be used in the study.

• 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 pregnant, lactating, or planning a pregnancy at the time of enrollment (by verbal confirmation at the screening visit).

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Test lens
contact lens
• Control lens
contact lens

Locations

Country	Name	City	State
United States	University Eye Center at Ketchum Health	Anaheim	California
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	Number of Participants With Lens Centration	Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (>0.5mm N T S I)	Baseline
Primary	Number of Participants With Lens Centration	Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (>0.5mm N T S I)	1 week
Primary	Post Blink Movement	Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink)	Baseline
Primary	Post Blink Movement	Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink)	1 week
Primary	Primary Gaze Lag	Primary Gaze Lag (measured in mm at 0.1mm steps)	baseline
Primary	Primary Gaze Lag	Primary Gaze Lag (measured in mm at 0.1mm steps)	1 week
Primary	Up Gaze Lag	Up Gaze Lag (measured in mm at 0.1mm steps)	Baseline
Primary	Up Gaze Lag	Up Gaze Lag (measured in mm at 0.1mm steps)	1 week
Primary	Push-Up Tightness	Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement)	baseline
Primary	Push-Up Tightness	Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement)	1 week
Primary	Overall Fit Acceptance	Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum	Baseline
Primary	Overall Fit Acceptance	Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum	1 week
Primary	Number of Participants With Overall Lens Fit Impression	Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable	Baseline
Primary	Number of Participants With Overall Lens Fit Impression	Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable	1 week
Secondary	Subjective Comfort Rating	Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable)	Baseline
Secondary	Subjective Comfort Rating	Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable)	1-week