Clinical Comparison of Two Soft Contact Lenses

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: Lens 2; Device: Lens 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT06251154

EX-MKTG-154

Details and patient eligibility

About

This study was designed to gather short-term clinical performance data for 2 soft contact lenses.

Full description

The purpose of this participant-masked, non-randomized, crossover controlled, non-dispensing, study was to compare the short-term performance of 2 daily disposable contact lenses after 15 minutes of daily wear each. The lenses were identical in all aspects except for diameter. Participants attended for 1 visit only which lasted for approximately 2 hours.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects will only be eligible for the study if:

  1. They were of legal age (18) and capacity to volunteer.
  2. They understood their rights as a research subject and were willing and able to sign a Statement of Informed Consent.
  3. They were willing and able to follow the protocol.
  4. They were wearing soft contact lenses, or had done so within the past two years.
  5. They were able to be fitted with the study lenses within the power range available.

Exclusion criteria

• Subjects will not be eligible if:

  1. They had an ocular disorder which would normally contra-indicate contact lens wear.
  2. They had a systemic disorder which would normally contra-indicate contact lens wear.
  3. They were using any topical medication such as eye drops or ointment.
  4. They were aphakic.
  5. They had had corneal refractive surgery.
  6. They had any corneal distortion resulting from previous hard or rigid lens wear or had keratoconus.
  7. They were pregnant or lactating.
  8. They had an eye or health condition including an immunosuppressive or infectious disease which could, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
  9. They had taken part in any contact lens or care system clinical research within two weeks prior to starting this study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Lens 1

Experimental group

Description:

All participants wore Lens 1 for 15 minutes (Period 1)

Treatment:

Device: Lens 1

Lens 2

Experimental group

Description:

All participants wore Lens 2 for 15 minutes (Period 2)

Treatment:

Device: Lens 2