Multicenter Dispensing Study of Biofinity Lenses in Extended Range

Myopia Clinical Trial

Official title:

Multicenter Dispensing Study of Biofinity Lenses in Extended Range

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02060539
• Other study ID #: CV-13-47
• Status: Completed
• Phase: N/A
• First received: February 6, 2014
• Last updated: November 8, 2017
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To obtain subjective and objective feedback on the clinical performance of Biofinity lenses after at least two weeks daily wear in existing contact lens wearers compared with their habitual lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Has had an 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 20/50 or better (in at least one eye) with their habitual vision correction

• Currently wears soft contact lenses

• They should require contact lens powers between -12.00 and -20.00D or between +8.00 and +15.00D

• Has clear corneas and no active ocular disease

• Demonstrates an acceptable fit with the study lenses.

Exclusion Criteria:

• Has any systemic disease affecting ocular health

• Is taking medication, such as antihistamine eye drops, oral and ophthalmic betaadrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants

• Have any active ocular disease and/or infection that would contraindicate contact lens wear.

• Active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

• Has worn gas permeable contact lenses within the last month.

• Is aphakic

• Has undergone corneal refractive surgery.

• Is participating in any other type of clinical research study

• Female who is currently pregnant or is breast-feeding.

Related Conditions & MeSH terms

• Hyperopia
• Myopia

Intervention

Device:
• Biofinity XR

Locations

Country	Name	City	State
Canada	CCLR, University of Waterloo	Waterloo	Ontario
United States	UC Berkeley Clinica Research Center	Berkeley	California
United States	TERTC, University of Houston	Houston	Texas
United States	CORL, Indiana University School of Optometry	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dryness (During Day and Dryness at Night)	Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained habitual lens history at baseline.	Baseline
Primary	Dryness (During Day)	Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.	Dispense
Primary	Dryness (During Day and Dryness at Night)	Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained at two weeks.	2 Weeks
Primary	Comfort (Insertion, End of Day, Overall)	Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline.	Baseline
Primary	Comfort (Insertion)	Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.	Dispense
Primary	Comfort (Insertion, End of Day, Overall)	Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.	2 Weeks
Primary	Ghosting (Multiple Images)	Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame ghosting. Cannot be worn. 100=No ghosting ever.) Obtained habitual lens history at baseline.	Baseline
Primary	Ghosting (Multiple Images)	Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme ghosting. Cannot be worn. 100=No ghosting ever.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.	Dispense
Primary	Ghosting (Multiple Images)	Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme ghosting. Cannot be worn. 100=No ghosting ever.) Obtained at 2 weeks.	2 Weeks
Primary	Hazing (Blurred Edges)	Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame haze. Cannot be worn. 100=No hazing experienced at any time.) Obtained habitual lens history at baseline.	Baseline
Primary	Hazing (Blurred Edges)	Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme haze. Cannot be worn. 100=No hazing experienced at any time.) Obtained at 2 weeks.	2 Weeks
Primary	Vision Quality (During Day and at Night)	Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained habitual lens history at baseline.	Baseline
Primary	Vision Quality (During Day)	Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.	Dispense
Primary	Vision Quality (During Day and at Night)	Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained at 2 weeks.	2 Weeks
Primary	Handling (Insertion, Removal, Overall)	Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline.	Baseline
Primary	Handling (Insertion, Removal, Overall)	Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.	2 weeks
Primary	Overall Satisfaction of Comfort, Vision, Handling	Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.	Dispense
Primary	Overall Satisfaction of Comfort, Vision, Handling	Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained habitual lens history at baseline.	Baseline
Primary	Overall Satisfaction of Comfort, Vision, Handling	Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained at baseline at 2 weeks.	2 Weeks
Primary	Comfort Preference	Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.	Dispense
Primary	Comfort Preference	Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.	2 Weeks
Primary	Vision Preference	Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.	Dispense
Primary	Vision Preference	Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.	2 Weeks
Primary	Handling Preference	Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.	2 Weeks
Primary	Overall Preference	Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.	Dispense
Primary	Overall Preference	Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.	2 Weeks
Secondary	Lens Centration - Habitual Lenses	Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained for habitual lenses at baseline.	Baseline
Secondary	Lens Centration	Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at baseline at dispense.	Dispense
Secondary	Lens Centration	Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at 2 weeks.	2 Weeks
Secondary	Lens Movement - Habitual Lenses	Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained for habitual lenses at baseline.	Baseline
Secondary	Lens Movement	Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.	Dispense
Secondary	Lens Movement	Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained at 2 weeks wear.	2 Weeks
Secondary	Overall Fit Acceptance	Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained for habitual lenses at baseline.	Baseline
Secondary	Overall Fit Acceptance	Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.	Dispense
Secondary	Overall Fit Acceptance	Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained at 2 weeks.	2 Weeks
Secondary	Visual Acuity	Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained for habitual lenses at baseline.	Baseline
Secondary	Visual Acuity	Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.	Dispense
Secondary	Visual Acuity	Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained at 2 weeks.	2 Weeks
Secondary	Anterior Ocular Physiological Response	Ocular response assessed with the slit lamp using a Visual Analog Scale (0-4, 0=none, 4=severe). Obtained for habitual lenses at baseline.	Baseline
Secondary	Anterior Ocular Physiological Response	Ocular response assessed with the slit lamp using a Visual Analog Scale (0-4, 0=none, 4=severe). Obtained at 2 weeks.	2 Weeks
Secondary	Average Wearing Time	Participant response when asked, "Number of hours worn today?" (hours per day) Obtained for habitual lens at baseline.	Baseline
Secondary	Average Wearing Time	Participant response when asked, "Number of hours worn today?" (hours per day) Obtained at 2 weeks.	2 Weeks