Multicenter Dispensing Study of Biofinity Lenses in Extended Range

NCT02060539 | Completed Results

• 1 other identifier: CV-13-47
• Study Type: interventional
• Target: 19
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Myopia; Hyperopia

Outcome Measures

Primary Outcomes (26)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (16)

• Lens Centration - Habitual Lenses

  Baseline

• Lens Centration

  Dispense

• Lens Centration

  2 Weeks

• Lens Movement - Habitual Lenses

  Baseline

• Lens Movement

  Dispense

Study Arms (1)

Biofinity XR

EXPERIMENTAL

Participants dispensed Biofinity XR lenses over two weeks of lens wear

Device: Biofinity XR

Interventions

Biofinity XR DEVICE

Biofinity XR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (4)

UC Berkeley Clinica Research Center

Berkeley, California, 94720-2020, United States

Location

CORL, Indiana University School of Optometry

Indianapolis, Indiana, 46266-6057, United States

Location

TERTC, University of Houston

Houston, Texas, 77204-2020, United States

Location

CCLR, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Myopia; Hyperopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Cheryl McKinnon
• Organization: CooperVision

cmckinnon@coopervision.com

925-251-2034

Study Officials

• Lyndon Jones

  CCLR, University of Waterloo

  PRINCIPAL INVESTIGATOR

• Meng Lin

  CRC, University of California Berkeley

  PRINCIPAL INVESTIGATOR

• Jan Bergmanson

  TERTC, University of Houston

  PRINCIPAL INVESTIGATOR

• Pete Kollbaum

  CORL, Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: February 12, 2014
• Study Start: October 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 11, 2017
• Results First Posted: June 30, 2015

Record last verified: 2015-06

Locations

US (3); CA (1)