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Daily Disposable Silicone Hydrogel Contact Lens, Stenfilcon A, Clinical Study

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ClinicalTrials.gov Identifier: NCT02637804
Recruitment Status : Completed
First Posted : December 22, 2015
Results First Posted : October 23, 2017
Last Update Posted : October 23, 2017
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Brief Summary:

Clinical evaluation of stenfilcon A compared with narafilcon A and delefilcon A

This is a total 120 subject, randomized, open label, bilateral wear, two week crossover study (each lens for 1 week) evaluating the clinical performance of stenfilcon A spherical lenses compared to narafilcon A or delefilcon A spherical lenses.


Condition or disease Intervention/treatment Phase
Myopia Device: stenfilcon A Device: narafilcon A Device: delefilcon A Not Applicable

Detailed Description:

The aim of this study is to evaluate the clinical performance of stenfilcon A compared with narafilcon A and delefilcon A.

The study participants will be allocated to two parallel groups (Group 1 and Group 2), 60 subjects each, based on the control lenses, narafilcon A and delefilcon A spherical lenses.

Study groups:

Group 1: stenfilcon A vs. narafilcon A

Group 2: stenfilcon A vs. delefilcon A


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study participants will be allocated in to 2 parallel groups: Group 1: stenfilcon A and narafilcon A, and Group 2: stenfilcon A and delefilcon A. Each participant will be randomized to wear either lens pair in a bilateral design for 1 week, and then cross over to the alternative pair.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Daily Disposable Silicone Hydrogel Contact Lens, Stenfilcon A, Clinical Study
Study Start Date : January 2016
Actual Primary Completion Date : March 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Active Comparator: stenfilcon A vs narafilcon A (Group 1)
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
Device: stenfilcon A
contact lens

Device: narafilcon A
contact lens

Active Comparator: stenfilcon A vs delefilcon A (Group 2)
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
Device: stenfilcon A
contact lens

Device: delefilcon A
contact lens




Primary Outcome Measures :
  1. Pain and Foreign Body Sensation [ Time Frame: 1 week ]
    Subjective ratings of pain and foreign body sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation

  2. Itching Sensation on Removal [ Time Frame: 1 week ]
    Subjective ratings of itching sensation on insertion for each lens pair assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation

  3. Red Eye Sensation [ Time Frame: 1 week ]
    Subjective ratings of red eye sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation

  4. Dryness [ Time Frame: 1 week ]
    Subjective ratings of dryness (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very dry, 10=no dryness at all.

  5. Comfort [ Time Frame: 1 week ]
    Subjective ratings of comfort (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor comfort, 10=very good comfort).

  6. Vision [ Time Frame: 1 week ]
    Subjective ratings of vision (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor vision, 10=very good vision).

  7. Handling [ Time Frame: 1 week ]
    Subjective ratings of handling (lens insertion and lens removal) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor handling, 10=very good handling.

  8. Lens Preference - Stenfilcon A/Narafilcon A (Group 1) [ Time Frame: 1 week ]
    Subjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer narafilcon A, prefer narafilcon A).

  9. Lens Preference - Stenfilcon A/Delefilcon A (Group 2) [ Time Frame: 1 week ]
    Subjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer delefilcon A, prefer delefilcon A).


Secondary Outcome Measures :
  1. Lens Fit - Horizontal Centration [ Time Frame: Baseline ]
    Lens fit evaluation of horizontal centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at baseline. (Temporal, Little temporal, Centered, Little nasal, Nasal)

  2. Lens Fit - Horizontal Centration [ Time Frame: 1 week ]
    Lens fit evaluation of horizontal centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Temporal, Little temporal, Centered, Little nasal, Nasal)

  3. Lens Fit - Vertical Centration [ Time Frame: Baseline ]
    Lens fit evaluation of vertical centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Upper, Little upper, Centered, Little lower, Lower)

  4. Lens Fit - Vertical Centration [ Time Frame: 1 week ]
    Lens fit evaluation of vertical centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Upper, Little upper, Centered, Little lower, Lower)

  5. Lens Fit - Post-blink Movement [ Time Frame: Baseline ]
    Lens fit evaluation of post-blink movement for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Tight, Little tight, Optimal, Little loose, Loose)

  6. Lens Fit - Post-blink Movement [ Time Frame: 1 week ]
    Lens fit evaluation of post-blink movement for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Tight, Little tight, Optimal, Little loose, Loose)

  7. Lens Fit Overall [ Time Frame: Baseline ]
    Lens fit evaluation overall for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Optimum, Good, Acceptable, Not acceptable (cannot wear))

  8. Lens Fit Overall [ Time Frame: 1 week ]
    Lens fit evaluation overall for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Optimum, Good, Acceptable, Not acceptable (cannot wear))

  9. Conjunctival Redness [ Time Frame: 1 week ]
    Conjunctival redness for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)

  10. Limbal Redness [ Time Frame: 1 week ]
    Limbal redness for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)

  11. Corneal Staining [ Time Frame: 1 week ]
    Corneal staining for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)

  12. Corneal Neovascularization [ Time Frame: 1 week ]
    Corneal neovascularization for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)

  13. Conjunctival Staining [ Time Frame: 1 week ]
    Conjunctival staining for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)

  14. Corneal Oedema [ Time Frame: 1 week ]
    Corneal oedema for for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)

  15. Papillary Conjunctivitis [ Time Frame: 1 week ]
    Papillary conjunctivitis for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- A person is eligible for inclusion in the study if he/she:

  • Is over 18 years of age (inclusive)
  • Has had a self-reported visual exam in the last two years
  • Is an adapted daily disposable non-silicone hydrogel spherical contact lens wearer
  • Can achieve best corrected spectacle distance visual acuity of 20/25 or better in each eye.
  • Can achieve a distance visual acuity of 20/30 or better in each eye with the study contact lenses.
  • Has clear corneas and no active ocular disease
  • Has read, understood and signed the information consent letter.
  • Has a CL (Contact Lens) spherical prescription between - 0.75 and - 8.00 (inclusive)
  • Is willing to comply with the wear schedule.
  • Is willing to comply with the visit schedule

Exclusion Criteria:

- A person will be excluded from the study if he/she:

  • Is not a habitual wearer of daily disposable non-silicone hydrogel spherical contact lenses
  • Has a CL prescription outside the range of the inclusion power range
  • Has a spectacle cylinder ≥1.00D of cylinder in either eye.
  • Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
  • Has contact lens best corrected distance vision worse than 20/25 in either eye
  • Presence of clinically significant (grade 2-4) anterior segment abnormalities
  • Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear
  • Slit lamp findings that would contraindicate contact lens wear
  • Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
  • Has aphakia, keratoconus or a highly irregular cornea.
  • Has undergone corneal refractive surgery.
  • Is participating in any other type of eye related clinical or research study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02637804


Sponsors and Collaborators
Coopervision, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Yuji Kodama, MD, PhD Director, Kodama Eye Clinic

Layout table for additonal information
Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT02637804     History of Changes
Other Study ID Numbers: JP-MKTG-201512
First Posted: December 22, 2015    Key Record Dates
Results First Posted: October 23, 2017
Last Update Posted: October 23, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided