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OpenTrials
Completed

NCT Number: NCT03139578

Short-Term Clinical Comparison of Two Silicone Hydrogel Daily Disposable Contact Lenses

This will be a 2 period one-day, double-masked, randomized, repeated measures, non-dispensing, cross-over study where the main purpose of this study is to compare the performance of a new daily disposable silicone hydrogel lens with that of an existing similar lens.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aston University Optometry and Vision Science, Birmingham, United Kingdom

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Potential subjects must satisfy all of the following criteria to be enrolled in the study:

  • The subject must read and sign the Informed Consent form.
  • The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  • Healthy adult males or females aged 18-55 years.
  • The subject's spherical contact lens requirement in the range +2.00 D to +4.00 D or -1.00 D to -6.00 D.
  • The subject's refractive cylinder must be ≤1.00 D in each eye.
  • The subject must have visual acuity best correctable to 6/9 (20/30) or better for each eye.
  • The subject is a current soft contact lens wearer (defined as a minimum of 6 hours of DW per day, at least 5 days per week, for a minimum of 1 month prior to the study).
  • The subject must have normal eyes (i.e., no ocular medications or infections of any type).

Exclusion criteria

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  • Currently pregnant or lactating
  • Any systemic disease (e.g., Sjögren's Syndrome),allergies, infectious disease (e.g., hepatitis,tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study.
  • Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear.
  • Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.
  • Extended wear contact lens correction.
  • Any current use of ocular medication.
  • Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
  • Any greater than Grade 2 slit lamp findings (e.g., oedema, corneal neovascularisation, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale or any other ocular abnormality that may contraindicate contact lens wear.
  • Any contact lens-related history or signs of a corneal inflammatory event, or any other ocular abnormality that would contraindicate contact lens wear.
  • Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrolment.
  • Employee, relative or friends of employees of any ophthalmic company, or investigational clinic (e.g., Investigator, Coordinator, Technician).

Treatment and study plan

Test 8.5BC

Device

senofilcon A contact lenses with 8.5 base curve

Test 9.0BC

Device

senofilcon A contact lenses with 9.0 base curve

Control 8.5BC

Device

narafilcon A contact lenses with 8.5 base curve

Control 9.0BC

Device

narafilcon A contact lenses with 9.0 base curve

Primary outcomes

  1. Overall Fit Acceptance

    Time frame: 30-45 minutes after lens settling

    Overall lens fit acceptance was assessed by the investigator based on lens fitting characteristics and graded on a scale of 0 to 5, where 0=should not be worn and 5=perfect fit. The score ranges from 0 to 5, where higher scores indicate better fitting. The number of eye for each Grade was reported.

  2. Lens Power Requirement

    Time frame: 30-45 minutes after lens settling

    The lens power requirements (aka sphere requirements) for each lens type was calculated by summing the lens power and the spherical over-refraction. Then the difference of lens power requirement between the Test and Control lenses was calculated (Test-Control).

Secondary outcomes

  1. Subjective Comfort at Lens Insertion

    Time frame: Immediately upon lens insertion

    Subjective comfort on insertion was assessed by the subject on an 11-point scale (0 to 10) where 0=painful and 10=can't be felt. The score ranges from 0 to 10, where higher scores indicate better comfort. The average comfort score for each lens was reported.

  2. Subjective Comfort After Lens Settling

    Time frame: 30-45 minutes after lens settling

    Subjective comfort on setting was assessed by the subject on an 11-point scale (0 to 10) where 0=painful and 10=can't be felt. The score ranges from 0 to 10, where higher scores indicate better comfort. The average comfort score for each lens was reported.

  3. Subjective Vision Quality

    Time frame: 30-45 minutes after lens settling

    Subjective vision quality was assessed by the subject on an 11-point scale (0 to 10) where 0=extremely blurred and 10=perfect. The score ranges from 0 to 10, where higher scores indicate better vision quality. The average vision quality score for each lens was reported.

  4. Subjective Handling

    Time frame: Immediately upon lens insertion

    Subjective handling was assessed by the subject on an 11-point scale (0 to 10) where 0=extremely difficult and 10=very easy. The score ranges from 0 to 10, where higher scores indicate better handling. The average handling score for each lens was reported.

  5. Monocular High Contrast Visual Acuity (VA)

    Time frame: 30-45 minutes after lens settling

    Monocular high contrast distance VA with the study lenses was collected to the nearest letter using computer generated logMAR charts. 0.02 logMAR is equivalent to 1 letter. Negative logMAR values indicate better lens performance. The average visual acuity was reported for each lens type.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 4, 2017
Registry last updated
Feb 1, 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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