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OpenTrials
Completed

NCT Number: NCT02196766

BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens

To determine if patients are unreactive to the lens care solution / Biofinity combination.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kokama Eye Clinic, Joyo-shi, Kyoto, Japan

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About this study

To determine if patients are unreactive to the lens care solution / Biofinity combination in this cross-over study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Is over 18 years of age (inclusive)
  • Has had a self-reported visual exam in the last two years
  • Is currently an adapted spherical soft CL wearer
  • Has a CL spherical prescription between - 0.25 and - 12.00 (inclusive)
  • Has less than 1.00D spectacle cylinder in each eye.
  • Is correctable to a visual acuity of 20/20 or better in both eyes
  • Has clear corneas and no active ocular disease
  • Has read, understood and signed the information consent letter.
  • Is willing to comply with the wear schedule (at least 40 hrs per week)
  • Is willing to comply with the visit schedule

Exclusion criteria

  • 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 - 0.25 to -12.00D
  • Has a spectacle cylinder greater than -0.75D of cylinder in either eye.
  • Has best corrected spectacle distance vision worse than 20/20 in either eye.
  • Has any systemic disease affecting ocular health.
  • Is using any systemic or topical medications that will affect ocular health.
  • Has any ocular pathology or severe insufficiency of lacrimal secretion
  • Has persistent, clinically significant corneal or conjunctival staining
  • Has active neovascularization or any central corneal scars.
  • Is aphakic.
  • Is pregnant or lactating.
  • Has undergone corneal refractive surgery.
  • Is participating in any other type of eye related clinical or research study.

Treatment and study plan

Bioclean First Care EX / comfilcon A

Other

Subjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the alternate combination.

Aosept Clearcare / comfilcon A

Other

Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the alternate combination.

Primary outcomes

  1. Ocular Health - Corneal Staining

    Time frame: 1 week

    Corneal staining for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).

  2. Ocular Health - Conjunctival Redness

    Time frame: 1 week

    Conjunctival redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).

  3. Ocular Health - Limbal Redness

    Time frame: 1 week

    Limbal redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).

  4. Ocular Health - Papillary Conjunctivitis

    Time frame: 1 week

    Papillary conjunctivitis for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).

Secondary outcomes

  1. Stinging Sensation Right After Insertion (Subjective Rating)

    Time frame: Baseline

    Subjective rating of stinging sensation for the combinations is assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).

  2. Burning Sensation Right After Insertion (Subjective Rating)

    Time frame: Baseline

    Subjective rating of burning sensation right after insertion for each combination assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Official study title

BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens: A Two Week Crossover Study

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 22, 2014
Registry last updated
Jul 29, 2020

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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