N/A N=84 Randomized Single-blind Treatment

Accommodative Relief for Uncomfortable Non-Presbyopes

Asthenopia

Bottom Line

View on ClinicalTrials.gov: NCT03544216 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2019

Primary outcome: Primary: Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score — 14.3; 12.8; 19.0 scores on a scale — p=<0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Multifocal Contact Lens (Device); Single Vision Contact Lens (Device)
Age: Adult · 30+ yrs
Sex: All
Sponsor: Ohio State University
Primary completion: May 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score	14.3; 12.8; 19.0	<0.001 sig

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).

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03544216). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.