Clinical Evaluation of Invigor Toric 1-Day Contact Lenses

Astigmatism Clinical Trial

Official title:

Clinical Evaluation of Invigor Toric 1-Day Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04016623
• Other study ID #: CV-19-27
• Status: Completed
• Phase: N/A
• Start date: May 6, 2019
• Est. completion date: June 4, 2019

Study information

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

Clinical Trial Summary

An evaluation of the clinical performance of the 1-day toric test contact lens compared to the 1-day toric control contact lens over one hour of lens wear.

Description:

A non-dispensing, double-masked, randomized, contralateral study comparing the 1-day toric test contact lens against the 1-day toric control contact lens to evaluate the clinical performance over one hour of lens wear. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye for each pair of lenses.

Each subject will be asked to wear four pairs of contact lenses in the study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 4, 2019
• Est. primary completion date: May 15, 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.

• Has clear corneas and no active ocular disease.

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

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 undergone corneal refractive surgery.

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

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• 1-day toric test contact lens
somofilcon A 1-day toric test contact lens
• 1-day toric control contact lens
somofilcon A 1-day toric control contact lens

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	Visibility of Toric Mark	Toric Mark visible or not visible. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	1 hour
Primary	Degree of Lens Orientation	Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees.; Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Baseline
Primary	Degree of Lens Orientation	Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees.; Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	15 minutes
Primary	Degree of Lens Orientation	Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees.; Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	1 hour
Primary	Toric Stability	Toric stability (maximal and minimal differences between extreme gazes) measured in degrees for up, down, right, and left gazes.; Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	15 minutes
Primary	Toric Stability	Rotational stability (maximal and minimal differences between extreme gazes) measured in degrees for up, down, right, and left gazes.; Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	1 hour
Primary	Degree of Rotational Recovery	Rotational Recovery for nasal and temporal - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	15 minutes
Primary	Degree of Rotational Recovery	Rotational Recovery for nasal and temporal - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	1 hour
Primary	Toric Fit Acceptance	Toric fit acceptance and preference scale 0-4 (0 = can't be worn, 4 = optimum). Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	15 minutes
Primary	Toric Fit Acceptance	Toric fit acceptance and preference scale 0-4 (0 = can't be worn, 4 = optimum). Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	1 hour
Primary	Toric Fit Preference	Investigator's toric fitting preference - Test lens , No Preference , Control lens.; Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Baseline
Primary	Toric Fit Preference	Investigator's toric fitting preference - Test lens, No Preference, Control lens.; Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	1 hour
Secondary	Measurement of Lens Horizontal Centration	Measurement of Lens Horizontal Centration in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	15 Minutes
Secondary	Measurement of Lens Horizontal Centration	Measurement of Lens Horizontal Centration in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	1 hour
Secondary	Measurement of Lens Vertical Centration	Lens Horizontal centration measured in mm. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	15 minutes
Secondary	Measurement of Lens Vertical Centration	Lens Horizontal centration measured in mm. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	1 hour
Secondary	Measurement of Lens Movement	Measurement of lens movement in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	15 minutes
Secondary	Measurement of Lens Movement	Measurement of lens movement in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	1 hour
Secondary	Lens Push-Up	Lens push-up measured in percentage. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	15 minutes
Secondary	Lens Push-Up	Lens push-up measured in percentage. Data for all 4 pairs were combined and analyzed (n=40 control lenses).	1 hour
Secondary	Primary Lens Gaze Lag	Primary lens gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	15 minutes
Secondary	Primary Lens Gaze Lag	Primary lens gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	1 hour
Secondary	General Lens Fit Acceptance	General lens fit acceptance and preference scale 0-4 (0 = unacceptable, 4 = optimal).; Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	15 minutes
Secondary	General Lens Fit Acceptance	General lens fit acceptance and preference scale 0-4 (0 = unacceptable, 4 = optimal).; Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	1 hour
Secondary	Up Gaze Lag	Up gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	15 minutes
Secondary	Up Gaze Lag	Up gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	1 hour
Secondary	General Lens Fit Preference	Investigator's general lens fit preference - Test lens, No preference, Control lens.; Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Baseline
Secondary	General Lens Fit Preference	Investigator's general lens fit preference - Test lens, No preference, Control lens.; Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	1 hour