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Clinical Evaluation of Hydrogel and Silicone Hydrogel Daily Disposable Toric Contact Lenses

NCT ID: NCT05805085

Last Updated: 2024-12-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-10

Study Completion Date

2023-11-16

Brief Summary

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This study was to evaluate the patient subjective experiences of two daily disposable toric contact lenses.

Detailed Description

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This was a participant masked, interventional, prospective, direct refit, bilateral wear study. The purpose of this study was to evaluate the patient subjective experiences of a hydrogel daily disposable toric contact lens when compared to a silicone hydrogel daily disposable toric contact lens 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 A

Participants wore Lens A for 15 minutes (Period 1)

Group Type EXPERIMENTAL

Lens A

Intervention Type DEVICE

Hydrogel Daily Disposable Toric Contact Lens for 15 minutes

Lens B

Participants wore Lens B for 15 minutes (Period 2)

Group Type EXPERIMENTAL

Lens B

Intervention Type DEVICE

Silicone Hydrogel Daily Disposable Toric Contact Lens for 15 minutes

Interventions

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Lens A

Hydrogel Daily Disposable Toric Contact Lens for 15 minutes

Intervention Type DEVICE

Lens B

Silicone Hydrogel Daily Disposable Toric Contact Lens for 15 minutes

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

A person was eligible for inclusion in the study if he/she:

* Is at least 18 years of age and has full legal capacity to volunteer.
* Has read and signed an information consent letter.
* Self-reports having a full eye examination in the previous two years.
* Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Habitual soft contact lens wearers who currently wear toric contact lenses, or use spectacles for all distances vision correction, for the past 3 months minimum.
* Has a contact lens spherical prescription between plano to - 10.00 (inclusive) best corrected visual acuity of 20/30 or better in either eye.
* Has refractive astigmatism no less than -0.75D and no more than 1.75D in both eyes.
* Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
* Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
* Has clear corneas and no active ocular disease.
* Has read, understood, and signed the information consent letter.

Exclusion Criteria

A person was excluded from the study if he/she:

1. Is participating in any concurrent clinical or research study.
2. Has any known active ocular disease and/or infection that contraindicates contact lens wear.
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
4. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
5. Has known sensitivity to the diagnostic sodium fluorescein used in the study.
6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment.
7. Has undergone refractive error surgery or intraocular surgery.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CooperVision, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juan G Carracedo Rodríguez, OD, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

University Complutense of Madrid

Locations

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Clinic of Optometry; Faculty of Optics and Optometry

Madrid, , Spain

Site Status

Countries

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Spain

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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EX-MKTG-146

Identifier Type: -

Identifier Source: org_study_id