Clinical Evaluation of Two Silicone Hydrogel Contact Lenses

NCT05313412 | Completed Results FDA Device

• 1 other identifier: C21-706 (EX-MKTG-127)
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to compare the short-term clinical performance and subjective acceptance of two silicone hydrogel soft contact lenses.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Ease of Lens Insertion

  Ease of Lens Insertion is measured on a scale of 0-100 (0-Unmanageable, Lenses impossible to insert; 100-Excellent. No problems with lens insertion)

  6 hours

Study Arms (2)

Lens A, Then Lens B

EXPERIMENTAL

Participants will wear Lens A for six hours and then cross over to wear Lens B for six hours.

Device: Lens A (comfilcon A lens); Device: Lens B (lehfilcon A lens)

Lens B, Then Lens A

EXPERIMENTAL

Participants will wear Lens B for six hours and then cross over to wear Lens A for six hours.

Device: Lens A (comfilcon A lens); Device: Lens B (lehfilcon A lens)

Interventions

Lens A (comfilcon A lens) DEVICE

6 hours

Lens A, Then Lens B; Lens B, Then Lens A

Lens B (lehfilcon A lens) DEVICE

6 hours

Lens A, Then Lens B; Lens B, Then Lens A

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• They are aged between 18 and 40 years.
• They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
• They are willing and able to follow the protocol.
• They have successfully worn contact lenses within six months of starting the study.
• They can be satisfactorily fitted with the study contact lenses.
• They have a contact lens spherical prescription between -0.25 to - 6.00D (inclusive) based on the ocular refraction.
• They have a spectacle cylindrical correction of -0.75D or less in each eye based on the ocular refraction.
• They own and habitually wear single vision spectacles.
• They can attain at least 0.20 logMAR distance high contrast visual acuity in each eye, with the study lenses.
• They agree not to participate in other clinical research while enrolled on this study.

You may not qualify if:

• They have an ocular disorder which would normally contraindicate contact lens wear.
• They have a systemic disorder which would normally contraindicate contact lens wear.
• They are using any topical medication such as eye drops or ointment.
• They are aphakic.
• They have had corneal refractive surgery.
• They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
• They are pregnant or breastfeeding.
• They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (eg HIV) or a history of anaphylaxis or severe allergic reaction.
• They have grade 3 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality, which would normally contraindicate contact lens wear.
• They have taken part in any other clinical trial or research, within two weeks prior to starting this study, which may impact on this particular work.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Eurolens Research

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jose A. Vega, OD, MSc, FAAO
• Organization: CooperVision

JVega2@coopervision.com

925-621-3761

Study Officials

• Philip Morgan, PhD,MCOptom

  Eurolens Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 6, 2022
• Study Start: January 27, 2022
• Primary Completion: April 21, 2022
• Study Completion: April 21, 2022
• Last Updated: May 9, 2023
• Results First Posted: May 9, 2023

Record last verified: 2022-09

Locations

GB (1)