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Pilot Clinical Performance of a Silicone Hydrogel Lens for Up to Six Nights of Extended Wear

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Alcon

Status

Completed

Conditions

Myopia
Refractive Errors
Hyperopia

Treatments

Device: Comfilcon A contact lens
Device: Lehfilcon A contact lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT04403542
CLY935-C008

Details and patient eligibility

About

The purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn continuously for up to 1 week.

Full description

Subjects will be randomized to wear the investigational contact lens in 1 eye and the commercially available contact lens in the other eye. Subjects will be expected to attend 3 scheduled study visits: Day 1 Screening/Baseline/Dispense; Day 2 Follow-up within 4 hours of awakening (after the first night of sleeping); and Week 1 Follow-up/Exit. The expected duration of exposure to each of the study lenses for all randomized, completed subjects was approximately 7 days / 6 nights of wear.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Able to understand and sign an IRB/IEC approved Informed Consent form.
  • Successful wear of spherical soft contact lenses in both eyes during the past 3 months for a minimum of 5 days/week and in an extended wear modality at least 1 night/week.
  • Best corrected visual acuity of 20/25 or better in each eye.
  • Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

  • Any condition, use of medications, or surgery that could contraindicate contact lens wear, as determined by the Investigator.
  • Any habitual wear of Biofinity contact lenses.
  • Pregnant or breast-feeding.
  • Other protocol specified exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

36 participants in 2 patient groups

LID018869 (OD) / Biofinity (OS)
Experimental group
Description:
Lehfilcon A contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear
Treatment:
Device: Lehfilcon A contact lens
Device: Comfilcon A contact lens
Biofinity (OD) / LID018869 (OS)
Active Comparator group
Description:
Comfilcon A contact lens worn in the right eye, with lehfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear
Treatment:
Device: Lehfilcon A contact lens
Device: Comfilcon A contact lens

Trial documents
2

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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