A Clinical Comparison of Two Soft Toric Contact Lenses

Not Applicable

Active, not recruiting

• Conditions: Astigmatism

• Registration Number: NCT06758089
• Lead Sponsor: CooperVision International Limited (CVIL)

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-11-08
• Study First Submitted: 2024-12-26
• Study First Submitted QC: 2024-12-26
• Last Update Submitted: 2024-12-26
• Primary Completion: 2025-01
• Study Completion: 2025-01
• Study First Posted: 2025-01-03
• Last Update Posted: 2025-01-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Subjective Overall Score	At the end of 15 minutes of daily wear	The primary outcome measure for this study is the subjective overall score on a scale of 0-100 (0= Extremely poor, unmanageable, cannot use lenses, 100= Excellent, highly impressed with these lenses overall).

Secondary Outcome Measures

Name	Time	Method
Subjective Vision	At the end of 15 minutes of daily wear	The secondary outcome measure for this study is the subjective vision on a scale of 0-100 (0= Extremely poor, intolerable, lenses cannot be worn, 100= Excellent, unaware of any visual loss).
Subjective Comfort	At the end of 15 minutes of daily wear	The secondary outcome measure for this study is the subjective comfort on a scale of 0-100 (0= Extremely uncomfortable, causes pain, cannot be tolerated, 100= Excellent, cannot be felt).

Trial Locations

Locations (1)

Eurolens Research; 🇬🇧 Manchester, United Kingdom