Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fitting Evaluation of Hydrogel and Silicone Hydrogel Sphere Design Contact Lenses

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: NCT03098745
Recruitment Status : Completed
First Posted : April 4, 2017
Results First Posted : April 9, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Brief Summary:
The aim of this non-dispensing fitting study is to evaluate the short term lens fit, vision performance of three monthly replacement sphere lenses.

Condition or disease Intervention/treatment Phase
Myopia Device: Omafilcon A Device: Somofilcon A Device: Omafilcon A - Proclear (PC) Not Applicable

Detailed Description:
This is a 40-subject, double masked, randomized, bilateral, non-dispensing fitting trial comparing hydrogel and silicone hydrogel lens materials. It is anticipated that this study will involve 2 visits for each lens pair, as follows: Visits: V1 (lens dispensing), V2 (1 hour post lens settling). Each subject will be randomized to wear each pair bilaterally in a series of three short fitting comparisons.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Fitting Evaluation of Hydrogel and Silicone Hydrogel Sphere Design Contact Lenses.
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : April 11, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear Seizures

Arm Intervention/treatment
Active Comparator: Omafilcon A
Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during the study.
Device: Omafilcon A
contact lens

Active Comparator: Somofilcon A
Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during the study.
Device: Somofilcon A
contact lens

Active Comparator: Omafilcon A - Proclear (PC)
Participants are randomized to wear omafilcon A - PC lens pair bilaterally for 1 hour during the study.
Device: Omafilcon A - Proclear (PC)
contact lens




Primary Outcome Measures :
  1. Visual Acuity [ Time Frame: Baseline (lens insertion), 1 hour ]
    High contrast distance visual acuity assessed for each lens pair using LogMAR chart at time of lens insertion, then assessing again 1 hour later with spectacles after lenses are removed.

  2. Comfort [ Time Frame: Insertion, 1hr ]
    Subjective comfort (Scale 0-100: 0=very uncomfortable, 100= very comfortable)

  3. Lens Centration [ Time Frame: Insertion ]
    Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable)

  4. Lens Centration [ Time Frame: 1 Hour ]
    Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable)

  5. Post-blink Lens Movement [ Time Frame: Insertion ]
    Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive)

  6. Post-blink Lens Movement [ Time Frame: 1 Hour ]
    Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive)

  7. Lens Fit Acceptance [ Time Frame: Insertion ]
    Investigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect)

  8. Lens Fit Acceptance [ Time Frame: 1 Hour ]
    Investigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect)

  9. Lens Fit Preference [ Time Frame: 1 Hour ]
    Investigator lens fit preference (Scale: omafilcon A, somofilcon A, omafilcon A - Proclear (PC))

  10. Limbal Redness [ Time Frame: 1 Hour ]
    Redness of limbal area (Scale: 0-4, 0 = none, 4=severe)

  11. Bulbar Redness [ Time Frame: 1 Hour ]
    Redness of bulbar conjunctiva (Scale: 0-4, 0 = none, 4=severe)



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

    • Is between 18 and 40 years of age (inclusive).
    • Has had a self-reported visual exam in the last two years.
    • Is an adapted soft CL (Contact Lens) wearer who is not wearing any of the study lenses.
    • Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
    • Has a spectacle cylinder up to 0.75D (Diopter) in each eye.
    • Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
    • Can achieve a distance visual acuity of 20/30 (0.18 logMAR) 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.
    • Patient contact lens refraction should fit within the available parameters of the study lenses.
    • 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:

    • 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 CL prescription outside the range of - 1.00 to - 6.00D
    • Has a spectacle cylinder ≥1.00D of cylinder in either eye.
    • Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) 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 such as:

      • Pathological dry eye or associated findings
      • Pterygium, pinguecula, or corneal scars within the visual axis
      • Neovascularization > 0.75 mm in from of the limbus
      • Giant papillary conjunctivitis (GCP) worse than grade 1
      • Anterior uveitis or iritis (past or present)
      • Seborrheic eczema, Seborrheic conjunctivitis
      • History of corneal ulcers or fungal infections
      • Poor personal hygiene
    • Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
    • Has aphakia, keratoconus or a highly irregular cornea.
    • Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
    • 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): NCT03098745


Locations
Layout table for location information
Mexico
Optometry Clinic, National Autonomous University
Mexico City, Mexico
Sponsors and Collaborators
Coopervision, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Ruben Velázquez Guerrero, MSc., FIACLE National Autonomous University, School of Optometry
  Study Documents (Full-Text)

Documents provided by Coopervision, Inc.:
Layout table for additonal information
Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT03098745    
Other Study ID Numbers: EX-MKTG-79
First Posted: April 4, 2017    Key Record Dates
Results First Posted: April 9, 2019
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Seizures
Myopia
Refractive Errors
Eye Diseases
Neurologic Manifestations
Nervous System Diseases