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OpenTrials
Completed

NCT Number: NCT03578926

Performance of Two Toric Silicone Hydrogel Contact Lenses

Prospective study to evaluate the clinical performance of fanfilcon A toric contact lens and senofilcon A toric contact lens after two weeks of wear.

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Key information

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

The aim of this prospective study is to evaluate the clinical performance of Avaira Vitality toric and ACUVUE OASYS® for ASTIGMATISM contact lenses after 2-weeks of wear in each pair.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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 contact lens wearer
  • Has a contact lens spherical prescription between +6.00 to - 9.00 (inclusive)
  • Have no less than -0.75D of astigmatism and no more than -2.25 D in both eyes.
  • 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 (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
  • Is willing to comply with the visit schedule

Exclusion criteria

  • Has a CL prescription outside the range of the available parameters of the study lenses.
  • Has a spectacle cylinder less than -0.75D or more than -2.50 D 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 (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

fanfilcon A toric lens

Device

contact lens

Other names: Avaira Vitality toric lens

senofilcon A toric lens

Device

contact lens

Other names: Acuvue Oasys for Astigmatism

Primary outcomes

  1. Lens Centration

    Time frame: Baseline

    Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable)

  2. Lens Centration

    Time frame: 2 weeks

    Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable)

  3. Corneal Coverage

    Time frame: Baseline

    Lens covering the cornea (Yes, No)

  4. Corneal Coverage

    Time frame: 2 weeks

    Lens covering the cornea (Yes, No)

  5. Post Blink Movement

    Time frame: Baseline

    Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement)

  6. Post Blink Movement

    Time frame: 2 weeks

    Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement)

Secondary outcomes

  1. Wearing Time

    Time frame: 2 weeks

    Average daily wearing time (hours/day)

  2. Comfortable Wearing Time

    Time frame: 2 weeks

    Comfortable daily wearing time (hours/day)

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Official study title

Performance of Toric Silicone Hydrogel Contact Lenses Following Two Weeks of Daily Wear

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 6, 2018
Registry last updated
Dec 10, 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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