Changes in Invitro and ex Vivo Lens Metrology With Daily Wear Contact Lenses

Alcon

Status: Completed

Conditions: Myopia

Treatments: Device: Acuvue Oasys; Device: Purevision; Device: Proclear; Device: Acuvue 2; Device: Air Optix Aqua; Device: Biofinity

Study type: Interventional

Funder types: Industry

Identifiers

NCT01100411

M-10-01

Details and patient eligibility

About

The purpose of this study is to evaluate changes in contact lens geometry after lens wear

Full description

The purpose of this study is to evaluate changes invitro and ex vivo in contact lens geometry in daily lens wear

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• • Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;

  • Be at least 18 years old;
  • Willing to comply with the wearing and clinical trial visit schedule as directed by the investigator;
  • Have ocular health findings considered to be "normal" and which would not prevent the participant from safely wearing contact lenses;
  • Has vision correctable to at least 6/12 (20/40) or better at distance in each eye with contact lenses;
  • Be experienced at wearing contact lenses.

Exclusion criteria

• • Any pre-existing ocular irritation, injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses;

  • Any systemic disease that adversely affects ocular health
  • An active corneal infection or any active ocular disease that would affect wearing of contact lenses;
  • Use of any topical ocular medication during trial with the exception of saline drops ;
  • Use of or a need for any systemic medication or topical medications which may alter normal ocular findings/are known to affect a participant's ocular health/physiology or contact lens performance
  • Eye surgery within 12 weeks immediately prior to enrolment for this trial;
  • Previous corneal refractive surgery;
  • Contraindications to contact lens wear;
  • Participated or currently enrolled in another clinical trial that may have affected vision or ocular physiology within the previous 2 weeks;
  • Be pregnant (formal testing of pregnancy is not required. A participant's verbal report is sufficient);
  • Worn soft contact lenses 2 calendar days or rigid gas permeable/ orthokeratology lenses 7 calendar days prior.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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35 participants in 6 patient groups

Air Optix Aqua

Active Comparator group

Description:

Contact lens material: Lotrafilcon A

Treatment:

Device: Air Optix Aqua

Biofinity

Active Comparator group

Description:

Contact lens material: Comfilcon A

Treatment:

Device: Biofinity

Proclear

Active Comparator group

Description:

Contact lens material: Omafilcon A

Treatment:

Device: Proclear

Acuvue Oasys

Active Comparator group

Description:

Contact lens material: Senofilcon A

Treatment:

Device: Acuvue Oasys

Acuvue 2

Active Comparator group

Description:

Contact lens material: Etafilcon A

Treatment:

Device: Acuvue 2

Purevision

Active Comparator group

Description:

Contact lens material: Balafilcon A

Treatment:

Device: Purevision