Accommodative Relief for Uncomfortable Non-Presbyopes

Study Overview
=================
Brief Summary
-----------------
This study will determine how multifocal contact lens correction affects symptoms of discomfort and asthenopia in a group of myopic contact lens wearers in the non-presbyopic age range (ages 30-40 years).

Detailed Description
-----------------
The purpose of this study is to determine how multifocal contact lenses affect contact lens comfort in non-presbyopic contact lens wearers. Current soft contact lens wearers who have symptoms of discomfort in their contact lenses will be recruited. Each subject (n = 84) will wear a single vision soft contact lens (Ultra single vision spherical lens) for two weeks and a low add power multifocal (Ultra for Presbyopia) for two weeks. Half of the subjects will wear the single vision lens first, and half of the subjects will wear the multifocal lens first. Initial lens group will be chosen randomly. Subjects will complete surveys that assess their vision and comfort which each lens, and ocular surface and accommodative/binocular vision status will be evaluated at the initial dispense and after wearing each lens for two weeks.

Official Title
-----------------
Accommodative Relief for Uncomfortable Non-Presbyopes

Conditions
-----------------
Asthenopia

Intervention / Treatment
-----------------
* Device: Multifocal Contact Lens
* Device: Single Vision Contact Lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Visual acuity of 20/25 or better in both eyes with habitual contact lenses -0.75 D or more myopic in both eyes -0.75 D or less astigmatism in both eyes Current single vision contact lens wearer who does not require a reading aid CLDEQ-8 score of 12 or more points with habitual contact lenses No history of ocular surgery or medication Reports digital device use of at least 3 hours per day No significant signs of dry eye (grade 1 or less ocular surface staining, Schirmer score of 7 mm or more, and tear break up time of 7 seconds or more in bother eyes) No significant binocular vision disorders in both eyes (eso or exophoria of 4 prism diopters or less at distance and near, near point of convergence of 6 mm or less, no history of strabismus or patching)

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Vision First<br>Subjects in this group will receive the single vision spherical (Bausch + Lomb ULTRA®) lens for the first two weeks and be crossed over to the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lens for the second two weeks.Therefore, this group will receive both study interventions. | Device: Multifocal Contact Lens<br>* The multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks<br>Device: Single Vision Contact Lens<br>* The single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks<br>|
| Experimental: Multifocal first<br>Subjects in this group will receive the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lenses for the first two weeks and be crossed over to the single vision spherical (Bausch + Lomb ULTRA®) lens for the second two weeks. Therefore, this group will receive both study interventions. | Device: Multifocal Contact Lens<br>* The multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks<br>Device: Single Vision Contact Lens<br>* The single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score | After wearing each lens type (single vision and multifocal) for 2 weeks, subjects will complete the CLDEQ-8, a survey that assesses symptoms of contact lens discomfort, to reports their symptoms of discomfort with each lens type. CLDEQ-8 scores with the multifocal will be compared to CLDEQ-8 scores of the single vision lens and the subjects' habitual contact lenses to determine if the multifocal improved comfort. Min-Max CLDEQ-8 range: 0-37 points Higher point values indicate more/worse symptoms | Baseline and after 2 weeks of contact lens wear with each study lens (single vision and multifocal) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contact Lens, Multifocal, Accommodation, Presbyopia