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Clinical Performance of Stenfilcon A Versus Filcon II 3

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ClinicalTrials.gov Identifier: NCT01808209
Recruitment Status : Completed
First Posted : March 11, 2013
Results First Posted : January 19, 2015
Last Update Posted : January 19, 2015
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Brief Summary:
Clinical Performance of Stenfilcon vs. Filcon II 3

Condition or disease Intervention/treatment Phase
Myopia Device: stenfilcon A Device: filcon II 3 Phase 4

Detailed Description:
The objective of this study is to compare the comfort and clinical performance of Stenfilcon vs. Filcon II 3 compared to subject's habitual contact lenses. The null hypothesis is that there is no difference in the clinical performance between the two sets of lenses.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Official Title: Clinical Performance of Stenfilcon A Versus Filcon II 3
Study Start Date : January 2013
Actual Primary Completion Date : April 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: stenfilcon A
Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Device: filcon II 3
Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Other Name: filcon II 3 (Daily Disposable Contact Lens)

Active Comparator: filcon II 3
Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Device: stenfilcon A
Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Other Name: stenfilcon A (Daily Disposable Contact Lens)




Primary Outcome Measures :
  1. Daily and Comfortable Wearing Time [ Time Frame: Baseline ]
    Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses.(The hours of average comfortable wearing time and average daily wearing time.)

  2. Daily and Comfortable Wearing Time [ Time Frame: 1 week ]
    Participant rating of lens Daily and Comfortable Wearing Time. Collected at 1 week wear for each lens.(The hours of average comfortable wearing time and average daily wearing time.)

  3. Handling [ Time Frame: 1 Week ]
    Participant rating for lens handling. Collected at 1 week. (Insertion: 0-100, 0= could not get it in and 100= went in without a problem. Removal: 0= could not get it out and 100= came out without a problem. Blister: 0=impossible and 100=came out extremely easily).

  4. Comfort [ Time Frame: Baseline ]
    Participant rating of lens comfort. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable,100=extreme comfort / cannot feel them at all)

  5. Comfort [ Time Frame: 1 Week ]
    Participant rating for comfort. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).

  6. Dryness [ Time Frame: Baseline ]
    Participant rating of lens dryness. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable, 100=extreme comfort/ cannot feel them at all)

  7. Dryness [ Time Frame: 1 Week ]
    Participant rating for dryness. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).

  8. Vision Quality [ Time Frame: Baseline ]
    Participant rating of vision quality. Collected at baseline for habitual lens. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp)

  9. Vision Quality [ Time Frame: 1 Week ]
    Participant rating of vision quality. Collected at 1 week. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp)

  10. Eye Whiteness [ Time Frame: Baseline ]
    Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white).

  11. Eye Whiteness [ Time Frame: 1 Week ]
    Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white).

  12. Overall Satisfaction [ Time Frame: Baseline ]
    Participant rating for overall satisfaction. Collected at baseline for habitual lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied).

  13. Overall Satisfaction [ Time Frame: 1 Week ]
    Participant rating for overall satisfaction. Collected at 1 week for study lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied).

  14. Visual Acuity logMAR [ Time Frame: Baseline ]
    Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at baseline for habitual lens. logMAR.

  15. Visual Acuity logMAR [ Time Frame: Dispense ]
    Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at dispense for study lenses. logMAR.

  16. Visual Acuity logMAR [ Time Frame: 1 Week ]
    Assessment of Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at 1 week for study lenses. logMAR

  17. Wettability [ Time Frame: 1 Week ]
    Participant rating for surface wettability. Collected at 1 week. Tear film analysis in seconds.


Secondary Outcome Measures :
  1. Blood Vessel Coverage [ Time Frame: Baseline ]
    Assessment of ocular health. Collected at baseline after removal of lenses. Percent of blood vessel coverage.

  2. Blood Vessel Coverage [ Time Frame: 1 Week ]
    Assessment of ocular health. Collected at 1 week after removal of lenses. Percentage of blood vessel coverage.

  3. Conjunctival Redness [ Time Frame: Baseline ]
    Assessment of ocular health. Collected at baseline after removal of lenses. Percentage of conjunctival redness.

  4. Conjunctival Redness [ Time Frame: 1 Week ]
    Assessment of ocular health. Collected at 1 week after removal of lenses. Percentage of conjunctival redness.

  5. Corneal Staining [ Time Frame: Baseline ]
    Assessment of ocular health. Collected at baseline after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )

  6. Corneal Staining [ Time Frame: 1 Week ]
    Assessment of ocular health. Collected at 1 week after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )

  7. Conjunctival Staining [ Time Frame: 1 Week ]
    Assessment of ocular health. Collected at 1 week after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must satisfy the following conditions prior to inclusion in the study:

  • Based on his/her knowledge, must be in good general health. Be of legal age (18 years) or older.
  • Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation.
  • Read, indicate understanding of, and sign Written Informed Consent (Appendix 1)
  • Require a contact lens prescription between -0.50 and -6.00 and have no more than -.75dioptor (D) of astigmatism in both eyes
  • Achieve visual acuity of 6/9 or better in each eye with a spherical contact lens prescription.
  • An existing soft contact lens wearer of any modality.
  • Must be able to wear their lenses at least 6 full days over the 7 days; 14 hours per day, assuming there are no contraindications for doing so.
  • Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
  • No amblyopia.
  • No evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes).
  • No clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings greater than Grade 2: corneal edema, tarsal abnormalities, and conjunctival injection).
  • No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea [infiltrates], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology.)
  • No aphakia

Exclusion Criteria:

Any of the following will render a subject ineligible for inclusion:

  • Neophytes, who have not worn lenses before
  • Greater than 0.75D of refractive astigmatism in either eye
  • Presence of clinically significant (grade 3 or above) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
  • Presence of ocular or systemic disease or need of medication which might interfere with contact lens wear.
  • Slit lamp findings that would contraindicate contact lens wear such as:
  • Pathological dry eye or associated findings
  • Pterygium, pinguecula or corneal scars within the visual axis
  • Neovascularization > 0.75 mm in from the limbus
  • Giant papillary conjunctivitis (GPC) Grade 3 or above
  • Anterior uveitis or iritis (past or present)
  • Seborrheic eczema, seborrheic conjunctivitis
  • History of corneal ulcer or fungal infections
  • Poor personal hygiene
  • A known history of corneal hypoesthesia (reduced corneal sensitivity).
  • Contact lens best corrected Snellen visual acuities (VA) worse than 6/9
  • Aphakia, Keratoconus or a highly irregular cornea

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): NCT01808209


Locations
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United Kingdom
University of Aston
Birmingham, West Midlands, United Kingdom, B4 7ET
Sponsors and Collaborators
Coopervision, Inc.
Investigators
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Principal Investigator: James Wolffsohn, PhD University of Aston Birmingham, West Midlands, United Kingdom

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Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT01808209     History of Changes
Other Study ID Numbers: EX-MKTG-40
First Posted: March 11, 2013    Key Record Dates
Results First Posted: January 19, 2015
Last Update Posted: January 19, 2015
Last Verified: January 2015