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Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses

NCT ID: NCT05656885

Last Updated: 2023-12-27

Study Results

Results available

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

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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

2022-09-27

Study Completion Date

2022-10-18

Brief Summary

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This was a single-blind (participant masked), interventional, prospective, direct refit, bilateral wear short-term fitting study.

Detailed Description

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The aim of this non-dispensing fitting study was to evaluate the short-term clinical performance of two soft spherical contact lenses after 15 minutes of daily wear each.

Conditions

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Myopia Hyperopia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

All participants received Lens A and then Lens B in fixed-sequence order.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Lens A

All participants wore Lens A for 15 minutes (Period 1)

Group Type EXPERIMENTAL

Lens A

Intervention Type DEVICE

Soft spherical hydrogel contact lens for 15 minutes

Lens B

All participants wore Lens B for 15 minutes (Period 2)

Group Type EXPERIMENTAL

Lens B

Intervention Type DEVICE

Soft spherical silicone hydrogel contact lens for 15 minutes

Interventions

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Lens A

Soft spherical hydrogel contact lens for 15 minutes

Intervention Type DEVICE

Lens B

Soft spherical silicone hydrogel contact lens for 15 minutes

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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 sphere contact lenses, or use spectacles for all distances vision correction, for the past 3 months minimum.
* Has refractive astigmatism no higher than -0.75DC.
* Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (powers +8.00 to -12.00DS)

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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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University Complutense of Madrid

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-142

Identifier Type: -

Identifier Source: org_study_id