A Clinical Comparison of Two Soft Toric Contact Lenses

CooperVision International Limited (CVIL)

Status: Active, not recruiting

Conditions: Astigmatism

Treatments: Device: Lens 1 (ocufilcon D); Device: Lens 2 (somofilcon A)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06758089

EX-MKTG-163

Details and patient eligibility

About

The aim of this study is to compare the short-term clinical performance of two toric contact lenses.

Full description

The aim of this study is to evaluate the short-term clinical performance of two toric contact lenses when compared to each other after 15 minutes of daily wear each.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. They are of legal age and capacity to volunteer.
2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They currently wear soft contact lenses, or have done so within the past two years.
5. They have ocular astigmatism in both eyes of between 0.75DC and 2.00DC.
6. They have a spherical component: plano to -7.00DS (based on ocular refraction).
7. They are expected to be able to be fitted with the study lenses within the power range available.

Exclusion criteria

1. They have an ocular disorder, which would normally contra-indicate contact lens wear.
2. They have a systemic disorder, which would normally contra-indicate contact lens wear.
3. They are using any topical medication such as eye drops or ointment.
4. They are aphakic.
5. They have had corneal refractive surgery.
6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
7. They are pregnant or breastfeeding.
8. They have an eye or health condition including an immunosuppressive or infectious disease which would, 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 have 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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40 participants in 2 patient groups

Lens 1 (ocufilcon D)

Experimental group

Description:

All participants will wear lens 1 for 15 minutes (Period 1).

Treatment:

Device: Lens 1 (ocufilcon D)

Lens 2 (somofilcon A)

Experimental group

Description:

All participants will wear lens 2 for 15 minutes (Period 2).

Treatment:

Device: Lens 2 (somofilcon A)