A Clinical Comparison of Two Soft Toric Contact Lenses

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-08

Study Completion Date

2025-01-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Astigmatism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Lens 1 (ocufilcon D)

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

Group Type EXPERIMENTAL

Lens 1 (ocufilcon D)

Intervention Type DEVICE

15 minutes of daily wear

Lens 2 (somofilcon A)

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

Group Type EXPERIMENTAL

Lens 2 (somofilcon A)

Intervention Type DEVICE

15 minutes of daily wear

Interventions

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Lens 1 (ocufilcon D)

15 minutes of daily wear

Intervention Type DEVICE

Lens 2 (somofilcon A)

15 minutes of daily wear

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No