Novel Multifocal Soft Contact Lens Study

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-14

Study Completion Date

2024-01-12

Brief Summary

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A single site, open label protocol will be used to evaluate the safety and quality of vision of a novel soft contact lens. Habitual contact lens wearers will be asked to come to the study site for one visit. Ocular health assessments and visual acuity will be completed with both the study lens and without.

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Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Distance Visual Acuity

Visual acuity will be measured while participant's wear study lenses.

Group Type EXPERIMENTAL

Investigational Contact Lens

Intervention Type DEVICE

A soft contact lens that will be worn only at the study visit.

Interventions

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Investigational Contact Lens

A soft contact lens that will be worn only at the study visit.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Ability to give informed consent
2. Any gender
3. Any racial or ethnic origin
4. 18 - 40 years of age
5. Distance visual acuity with best corrected visual acuity of 20/25 with each eye
6. Habitual soft contact lens wearer with myopia
7. Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the investigator).

Exclusion Criteria

1. Current or active ocular inflammation or infection as determined by the Investigator.
2. Astigmatism \> 0.75 D in either eye
3. History of previous eye surgery
4. Demonstration or history of corneal ectasia or keratoconus.
5. Pregnant or lactating.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes