Clinical Comparison of Two Soft Contact Lenses

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Lens 1; Device: Lens 2

• Registration Number: NCT06251154
• Lead Sponsor: Coopervision, Inc.

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2023-12-11
• Status Verified: 2024-01
• Primary Completion: 2024-01-08
• Study Completion: 2024-01-08
• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-02-08
• Study First Posted: 2024-02-09
• Results First Submitted: 2024-03-18
• Results First Submitted QC: 2024-03-18
• Results First Posted: 2024-04-16
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lens 1	Lens 1	All participants wore Lens 1 for 15 minutes (Period 1)
Lens 2	Lens 2	All participants wore Lens 2 for 15 minutes (Period 2)

Primary Outcome Measures

Name	Time	Method
Subjective Overall Score	15 minutes	Subjective overall score was assessed using 0-100 visual analogue scale, where 0=Extremely poor, unmanageable, cannot use lenses and 100=Excellent, highly impressed with these lenses overall

Secondary Outcome Measures

Name	Time	Method
Subjective Vision	15 minutes	Subjective vision score was assessed using a 0-100 visual analogue scale, where 0=Extremely poor, intolerable, lens cannot be worn and 100=Excellent, unaware of any visual loss
Subjective Comfort	15 minutes	Subjective comfort score was assessed using 0-100 visual analogue scale, where 0=Extremely uncomfortable, causes pain, cannot be tolerated and 100=Excellent, cannot be felt

Trial Locations

Locations (1)

Eurolens Research; 🇬🇧 Manchester, United Kingdom