Evaluating Contact Lens Optics

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05028790

Enrollment

Registered

2021-08-31

Start date

2022-02-27

Completion date

2022-12-13

Last updated

2024-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Brief summary

This study will evaluate changes in refractive error and visual performance between a single vision soft contact lens and multifocal soft contact lens

Interventions

DEVICESingle vision contact lens

Participants will wear a single vision soft contact lens during the study visit

DEVICEMultifocal contact lens

Participants will wear a multifocal soft contact lens during the study visit

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

SINGLE (Subject)

Masking description

Participants were masked to the order in which they wore contact lenses

Eligibility

Sex/Gender

ALL

Age

18 Years to 39 Years

Healthy volunteers

Inclusion criteria

* Able to read and understand the informed consent document * 18 to 39 years of age (inclusive) * Best corrected visual acuity of 20/25 or better in the right eye * Refractive error from -1.00D to -6.00D with astigmatism less than or equal to -1.00D in the right eye (corneal plane)

Exclusion criteria

* Any ocular or systemic conditions affecting vision, refraction, or the ability to wear a soft contact lens * History of ocular trauma or surgery causing abnormal or distorted vision * Current Rigid Gas Permeable (RGP) contact lens wearers * Unwilling to have contact lens fit photographed * Pregnant and/or lactating females, by self-report

Design outcomes

Primary

Measure	Time frame	Description
Visual Performance	Through completion of study visit, an average of 2.5 hours	Low contrast visual acuity was measured for each participant while wearing each of the two lenses

Secondary

Measure	Time frame	Description
Spherical Equivalent Refractive Error On-axis	Through completion of study visit, an average of 2.5 hours	Refraction was measured after cycloplegia with two drops of 1% tropicamide hydrochloride. Spherical equivalent refractive error was then measured 3 times with an aberrometer and averaged.
Spherical Equivalent Refractive Error at 30 Degrees Temporal Retina	Through completion of study visit, an average of 2.5 hours	Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.
Spherical Equivalent Refractive Error at 20 Degrees Temporal Retina	Through completion of study visit, an average of 2.5 hours	Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.
Spherical Equivalent Refractive Error at 20 Degrees Nasal Retina	Through completion of study visit, an average of 2.5 hours	Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.
Spherical Equivalent Refractive Error at 30 Degrees Nasal Retina	Through completion of study visit, an average of 2.5 hours	Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Single Vision Soft Contact Lens First, Then Multifocal Soft Contact Lens Participants wore the single vision soft contact lens first, then the multifocal soft contact lens	9
Multifocal Soft Contact Lens First, Then Single Vision Soft Contact Lens Participants wore the multifocal soft contact lens first, then the single vision soft contact lens	7
Total	16

Baseline characteristics

Characteristic	Single Vision Soft Contact Lens First, Then Multifocal Soft Contact Lens	Total	Multifocal Soft Contact Lens First, Then Single Vision Soft Contact Lens
Age, Continuous	25.11 years STANDARD_DEVIATION 1.83	24.63 years STANDARD_DEVIATION 1.63	24 years STANDARD_DEVIATION 1.15
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants	16 Participants	7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	2 Participants	5 Participants	3 Participants
Race (NIH/OMB) Black or African American	3 Participants	3 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	4 Participants	8 Participants	4 Participants
Region of Enrollment United States	9 Participants	16 Participants	7 Participants
Sex: Female, Male Female	8 Participants	14 Participants	6 Participants
Sex: Female, Male Male	1 Participants	2 Participants	1 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 9	0 / 7
other Total, other adverse events	0 / 9	0 / 7
serious Total, serious adverse events	0 / 9	0 / 7