A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear

NCT01952665 | Completed Results

• 1 other identifier: EX-MKTG-41
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 6

Brief Summary

A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear

Conditions

Myopia

Outcome Measures

Primary Outcomes (36)

• Comfort at Insertion

  Participant rating for lens comfort on insertion. Collected at dispense for both study lens pairs. (0-10, 0= Very Uncomfortable, 10= Cannot feel).

  Dispense

• Visual Quality

  Participant rating of visual quality. Collected at dispense for both study pairs. (0-10, 0= Very Poor Vision, 10= Perfectly Sharp, Clear Vision)

  Dispense

• Average Daily Wearing Time

  Participants measure of average daily wear time for study lenses at 2 Weeks.

  2 weeks

• Comfortable Wearing Time

  Participant rating of lens Comfortable Wearing Time for both study pairs. After 2 weeks wear for each pair. (The hours of average comfortable wearing time)

  2 weeks

• Comfort

  Participant rating for lens comfort. After 2 weeks wear for each study pair. (0-10, 0= Very Uncomfortable, 10= Cannot Feel).

  2 weeks

• Dryness

  Participant rating for lens dryness. After 2 weeks wear for each study pair. (0-10, 0= Very Dry, 10= No Dryness).

  2 weeks

• Handling

  Participant rating for lens handling. After 2 weeks wear for each study pair. (0-10, 0= Very Difficult, 10= Very Easy).

  2 weeks

• Vision Satisfaction

  Participant rating for vision satisfaction. After 2 weeks wear for each study pair. (0-10, 0= Very Unsatisfied, 10= Very Satisfied)

  2 weeks

• Eye Whiteness/Redness

  Participant rating for Eye Whiteness/Redness. After 2 weeks wear for each study pair. (0-10, 0= Significant Redness, 10= Totally White)

  2 weeks

• Overall Sensation of Moistness

  Participant rating of overall sensation for moistness (hydration). After 2 weeks wear for each study pair. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.

  2 weeks

• Overall Sensation of Smoothness

  Participant rating of overall sensation for smoothness (deposit resistance). After 2 weeks wear for each study pair. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.

  2 weeks

• Overall Comfort Satisfaction

  Participant rating of satisfaction regarding comfort. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied

  2 weeks

• Overall Dryness Satisfaction

  Participant rating of satisfaction regarding dryness. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied

  2 weeks

• Overall Handling Satisfaction

  Participant rating of satisfaction regarding handling. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied

  2 weeks

• Overall Vision Satisfaction

  Participant rating of satisfaction regarding vision. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied

  2 weeks

• Overall Satisfaction

  Participant rating of satisfaction overall. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied

  2 weeks

• Lens Preference, Pair 1 Comfilcon A

  Participant preference for habitual lenses or study lenses with regard to comfort, dryness, handling, vision and overall. Collected at 2 weeks for study pair 1. (Randomized to comfilcon A as pair 1; Forced choice: Pair 1 or Habitual)

  2 weeks

• Lens Preference, Pair 1 Lotrafilcon B

  Participant preference for habitual lenses or study lenses with regard to comfort, dryness, handling, vision and overall. Collected at 2 weeks for study pair 1. (Randomized to lotrafilcon B as pair 1; Forced choice: Pair 1 or Habitual )

  2 weeks

• Comfortable Wearing Time

  Participant rating of lens Comfortable Wearing Time for both study pairs. Collected at 4 weeks wear. (The hours of average comfortable wearing time)

  4 weeks

• Average Daily Wearing Time

  Participants measure of average daily wear time for study lenses at 4 weeks.

  4 weeks

• Rewetting Drops

  Participant use of rewetting drops. Collected at 4 weeks wear for both study lens pairs. (Uses rewetting drops / Does not use rewetting drops).

  4 weeks

• Comfort

  Participant rating for lens comfort. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Uncomfortable, 10= Cannot Feel).

  4 weeks

• Dryness

  Participant rating for lens dryness. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Dry, 10= No Dryness).

  4 weeks

• Handling

  Participant rating for lens handling. Collected at 4 weeks. (0-10, 0= Very Difficult, 10= Very Easy).

  4 weeks

• Vision Satisfaction

  Participant rating for vision satisfaction. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Unsatisfied, 10= Very Satisfied)

  4 weeks

• Eye Whiteness/Redness

  Participant rating for Eye Whiteness/Redness. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Significant Redness, 10= Totally White)

  4 weeks

• Overall Sensation of Moistness

  Participant rating of overall sensation for moistness (hydration). Collected at 4 weeks wear for both study lens pairs. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.

  4 weeks

• Overall Sensation of Smoothness

  Participant rating of overall sensation for smoothness (deposit resistance). Collected at 4 weeks wear for both study lens pairs. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.

  4 weeks

• Overall Comfort Satisfaction

  Participant rating of satisfaction regarding comfort. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied

  4 weeks

• Overall Dryness Satisfaction

  Participant rating of satisfaction regarding dryness. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied

  4 weeks

• Overall Handling Satisfaction

  Participant rating of satisfaction regarding handling. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied

  4 weeks

• Overall Vision Satisfaction

  Participant rating of overall satisfaction for vision. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied

  4 weeks

• Overall Satisfaction

  Participant rating of satisfaction overall. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied

  4 weeks

• Lens Preference

  Participant lens preference in regard for comfort, dryness, handling, vision and overall. Collected at 4 weeks. (Forced Choice; Study Pair 1, Study Pair 2).

  4 weeks

• Lens Preference Comfort, Dryness, Vision and Overall.

  Participant lens preference regarding comfort, dryness, vision and overall. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual).

  4 weeks

• Lens Preference for Handling

  Participant lens preference regarding handling. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual).

  4 weeks

Secondary Outcomes (29)

• Binocular Visual Acuity logMAR

  Dispense

• Surface Wetting

  Dispense

• Surface Deposition

  Dispense

• Centration

  Dispense

• Corneal Coverage

  Dispense

Other Outcomes (1)

• The Number of Trials Needed to Achieve Final Dispensing Pair of Study Lenses.

  Dispense

Study Arms (2)

comfilcon A

ACTIVE COMPARATOR

Daily wear soft contact lens comfilcon A

Device: lotrafilcon B

lotrafilcon B

ACTIVE COMPARATOR

Daily wear soft contact lens lotrafilcon B

Device: comfilcon A

Interventions

comfilcon A DEVICE

Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.

lotrafilcon B

lotrafilcon B DEVICE

Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.

comfilcon A

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Is between 18 and 40 years of age (inclusive)
• Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study
• Has had a self-reported visual exam in the last two years
• Is an adapted soft CL wearer
• Has a Contact Lens (CL) spherical prescription between - 1.00 and - 9.00 (inclusive)
• Has less than 0.75D spectacle cylinder in each eye
• Is correctable to a visual acuity of 20/25 or better in both eyes
• Has clear corneas and no active ocular disease
• Has read, understood and signed the information consent letter
• Is willing to comply with the wear schedule (at least 40 hrs per week)
• Is willing to comply with the visit schedule

You may not qualify if:

• Has never worn contact lenses before
• Currently wears rigid gas permeable contact lenses
• Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day)
• Has a contact lens prescription outside the range of - 1.00 to -9.00D
• Has a spectacle cylinder greater than -0.50D of cylinder in either eye
• Has best corrected spectacle distance vision worse then 20/25 in either eye
• 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
• Has persistent, clinically significant corneal or conjunctival staining
• Has active neovascularization or any central corneal scars
• Is aphakic
• Is presbyopic
• Has undergone corneal refractive surgery
• Is participating in any other type of eye related clinical or research study

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (6)

Family Eye Care Center

Campbell, California, 95008, United States

Location

Golden Optometric Group

Whittier, California, 90606, United States

Location

Drs. Quinn, Foster, &Associates

Athens, Georgia, 45701, United States

Location

Davis EyeCare Associates

Oak Lawn, Illinois, 60453, United States

Location

Kannarr Eye Care LLC

Pittsburg, Kansas, 66762, United States

Location

Complete Eye Care of Medina

Medina, Minnesota, 55340, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Donald Siegel, OD Principal Investigator
• Organization: CooperVision

dsiegel@coopervision.com

(949) 597-4700

Study Officials

• Donald Siegel, OD

  CooperVision, US

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: September 30, 2013
• Study Start: October 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: March 1, 2014
• Last Updated: June 26, 2017
• Results First Posted: September 24, 2015

Record last verified: 2017-05

Locations

US (6)