MedDataX Logo

The Comparative Clinical Performance of Two Daily Disposable Toric Contact Lenses

NCT ID: NCT05020990

Last Updated: 2023-12-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-05-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aimed to compare the clinical performance of two daily disposable toric contact lenses.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This was a multi-center, randomized, participant-masked, bilateral study controlled by cross-comparison. Participants were assigned to either lens type in random sequence. Lenses were worn on a daily disposable wear schedule. Follow-up visits for each lens were performed after 1 week of wear.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Astigmatism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lens A, then Lens B

Participants wore Lens A for one week, then crossed over to wear Lens B for one week.

Group Type EXPERIMENTAL

Lens A (delefilcon A)

Intervention Type DEVICE

Daily disposable for one week

Lens B (stenfilcon A)

Intervention Type DEVICE

Daily disposable for one week

Lens B, then Lens A

Participants wore Lens B for one week, then crossed over to wear Lens A for one week.

Group Type EXPERIMENTAL

Lens A (delefilcon A)

Intervention Type DEVICE

Daily disposable for one week

Lens B (stenfilcon A)

Intervention Type DEVICE

Daily disposable for one week

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lens A (delefilcon A)

Daily disposable for one week

Intervention Type DEVICE

Lens B (stenfilcon A)

Daily disposable for one week

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. They are at least 18 years old and have the 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 in the past two years.
5. They have a spherical component of their contact lens prescription between Plano to - 6.00DS (inclusive).
6. They have a cylindrical component of their contact lens prescription between -0.75DC and -2.50DC (inclusive).
7. They can be satisfactorily fitted with the study lens types.
8. At dispensing, they could attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
9. They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
10. They own a wearable pair of spectacles.
11. They agree not to participate in other clinical research while enrolled on this study.

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 any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
9. They have eye or health conditions including immunosuppressive or infectious diseases, 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.
10. They are currently wearing one of the study contact lenses.
11. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

CooperVision, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Philip Morgan

Role: PRINCIPAL_INVESTIGATOR

Eurolens Research

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cameron Optometry

Edinburgh, Edinburg, United Kingdom

Site Status

Simon Falk Eyecare

Oakwood, Leeds, United Kingdom

Site Status

Phipps Opticians

Heckmondwike, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C20-691 (EX-MKTG-121)

Identifier Type: -

Identifier Source: org_study_id