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Completed

NCT Number: NCT03098745

Fitting Evaluation of Hydrogel and Silicone Hydrogel Sphere Design Contact Lenses

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

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Optometry Clinic, National Autonomous University

Mexico City, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

omafilcon A

Device

contact lens

somofilcon A

Device

contact lens

Omafilcon A - Proclear (PC)

Device

contact lens

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Official study title

Fitting Evaluation of Hydrogel and Silicone Hydrogel Sphere Design Contact Lenses.

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 4, 2017
Registry last updated
Apr 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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