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A Dispensing Clinical Trial of a Study Test Silicone Hydrogel Lens Against Control Lens Over 1 Week

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02500368
Recruitment Status : Completed
First Posted : July 16, 2015
Results First Posted : February 17, 2017
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Brief Summary:
This is a 1-week dispensing, double-masked, randomized, bilateral study comparing the test lens against the control lens.

Condition or disease Intervention/treatment Phase
Myopia Device: silicone hydrogel lens (test) Device: enfilcon A lens (control) Not Applicable

Detailed Description:

The order of lens wear (test lens first, control lens second or control lens first, test lens second) will be selected according to a randomization table.

Both test and control lenses will be used in a daily wear modality for 1 week. It is anticipated that this study will involve following visits: Baseline (screening and dispense of 1st study pair of lenses, visit combined), 1-week visit (follow-up of the 1st study pair of lenses and dispense the 2nd study pair of lenses) and 2-week visit (1 week follow-up of the 2nd study pair of lenses).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Dispensing Clinical Trial of a Study Test Silicone Hydrogel Lens Against Control Lens Over 1 Week
Study Start Date : July 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: silicone hydrogel lens (test)
Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.
Device: silicone hydrogel lens (test)
contact lens

Active Comparator: enfilcon A lens (control)
Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.
Device: enfilcon A lens (control)
contact lens




Primary Outcome Measures :
  1. Comfort [ Time Frame: Baseline and 1 week ]
    Subjective ratings scale (0-100) assessed: 0=Cannot be worn, causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever. Time points for comfort: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.

  2. Dryness [ Time Frame: Baseline and 1 week ]
    Subjective ratings scale (0-100): 0=Cannot be worn, extremely dry, 20=Frequently Irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=No dryness experienced at any time. Time points for dryness: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.


Secondary Outcome Measures :
  1. Lens Wettability [ Time Frame: Baseline and 1 week ]
    Grading scale 0-4, 0.25 steps, 0=excellent; 4=severely reduced.

  2. Surface Appearance [ Time Frame: Baseline ]
    Grade ratings category (smooth, grainy, or other)

  3. Surface Appearance [ Time Frame: 1 week ]
    Grade ratings category (smooth, grainy, or other)

  4. High Contrast Acuity at High Room Illumination [ Time Frame: Baseline and 1 week ]
    Logarithm of the Minimum Angle or Resolution (LogMAR) Chart

  5. Lens Deposition [ Time Frame: Baseline and 1 week ]
    Lens Deposits Scale 0-4, 0.25 steps. 0=excellent; 4=severely reduced

  6. Lens Problems [ Time Frame: Baseline and 1 week ]
    Lenses were evaluated for defects, scratches, fibers, blue specks, and other findings.

  7. Lens Centration [ Time Frame: Baseline ]

    Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered.

    (mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior


  8. Lens Centration [ Time Frame: 1 week ]

    Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered.

    (mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior


  9. Post-blink Movement [ Time Frame: Baseline and 1 week ]
    Post-blink movement evaluated by estimating the distance the lens was moving immediately after a blink. Primary Gaze: (mm, 0.1 steps)

  10. Lens Tightness [ Time Frame: Baseline and 1 week ]
    Lens tightness Scale 0%-100%, 0%=extremely loose fit, 50%=optimal push resistance and smooth return, 100%=no movement.

  11. Visual Quality [ Time Frame: Baseline and 1 week ]
    Subjective ratings scale (0-100): 0=Extremely poor vision all of the time; cannot function, 20=Frequently annoying vision problems, 40=Occasionally annoying vision problems, 60=Occasionally noticeable but not annoying vision problems, 80=Rarely noticeable vision problems, 100=Excellent vision all of the time. Different time points were taken for vision quality: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.

  12. Ease of Lens Insertion [ Time Frame: Baseline and 1 week ]
    Subjective ratings scale (0-100): 0=Could not place lens on eye, 20=Frequently takes multiple attempts to place on eye; often unsuccessful, 40=Frequently takes multiple attempts to place on eye, 60=Occasionally takes a few attempts to place on eye, 80=Rarely difficult to place on eye, 100=Always easy to place lens on eye

  13. Ease of Lens Removal [ Time Frame: 1 week ]
    Subjective ratings scale (0-100): 0=Could not remove lens from eye, 20=Frequently takes multiple attempts to remove from eye; often unsuccessful, 40=Frequently takes multiple attempts to remove from eye, 60=Occasionally takes a few attempts to remove from eye, 80=Rarely difficult to remove from eye, 100=Always easy to remove lens from eye.

  14. Overall Lens Fit [ Time Frame: Baseline and 1 week ]

    Overall Lens Fit Scale 0-4, 0.25 steps 0=Very poor (lens should not be worn at all);

    1. Poor (lens could be worn with supervision only);
    2. Fair (would prefer to refit, but clinically acceptable);
    3. Good (fit could be slightly improved);
    4. Very good (optimal)

  15. Bulbar Hyperemia [ Time Frame: Baseline and 1 week ]
    Bulbar hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.

  16. Limbal Hyperemia [ Time Frame: Baseline and 1 week ]
    Limbal hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.

  17. Corneal Dehydration Staining [ Time Frame: 1 week ]
    Corneal Staining: Dehydration Staining: Yes/No

  18. Corneal Staining (Extent) [ Time Frame: Baseline and 1 week ]

    Corneal staining extent, grade as % of each zone:

    C - Central, N - Nasal, T - Temporal, S - Superior, I - Interior


  19. Conjunctival Indentation [ Time Frame: Baseline and 1 week. ]
    Conjunctival Indentation 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4, 0.5 steps; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe

  20. Conjunctival Staining [ Time Frame: Baseline and 1 week ]
    Conjunctival Staining 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4; 0.5 steps, 0=None,1=Minimal diffuse punctuate, 2=Coalescent punctuate, 3=Confluent, 4=Deep confluent



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older 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 at least 17 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 20/30 or better (in each eye) with their habitual correction and the assigned study lenses
  • Is an adapted soft contact lens wearer (For the purpose of this study: Current lens wear at least 3 days per week, 8 hours each day.)

Exclusion Criteria:

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

  • Is participating in any concurrent clinical or research study
  • Has any known active* ocular disease and/or infection
  • Has a systemic condition that in the opinion of the investigator may affect a study outcome variable**
  • Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
  • Has known sensitivity to the diagnostic pharmaceuticals to be used in the study
  • Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
  • Is aphakic
  • Has undergone corneal refractive surgery.

For the purposes of this study, 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. Participants will be excluded with significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 3 or above: corneal edema, tarsal abnormalities, and conjunctival injection) or active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology)

For the purposes of this study, participants will be excluded**, if currently taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants


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): NCT02500368


Locations
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Canada, Ontario
Center for Contact Lens Research, University of Waterloo
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
Coopervision, Inc.
Investigators
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Principal Investigator: Lyndon Jones, PhD FCO Center for Contact Lens Research, University of Waterloo
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Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT02500368    
Other Study ID Numbers: CV-15-36
First Posted: July 16, 2015    Key Record Dates
Results First Posted: February 17, 2017
Last Update Posted: February 17, 2017
Last Verified: December 2016
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases