Toric Contact Lens Performance Study

Astigmatism Clinical Trial

Official title:

Toric Contact Lens Performance Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03546647
• Other study ID #: Study00000682
• Status: Completed
• Phase: N/A
• Start date: June 18, 2018
• Est. completion date: December 21, 2018

Study information

• Verified date: June 2021
• Source: University of Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study seeks to quantify digital visual performance and subjective visual acceptance of toric contact lenses as compared to spherical lenses in low to moderate astigmatic patients.

Description:

This is a prospective, single site, randomized, masked, crossover study. This study will evaluate the ability of toric contact lenses to decrease signs and symptoms of asthenopia and improve digital reading performance. Symptoms and objective near vision outcomes will be measured at baseline and after 1 week of wear with each correction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 21, 2018
• Est. primary completion date: December 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

Inclusion

+6.00 to -6.00 D vertexed sphere power and -0.75 to -1.50 D vertexed refractive cylinder in the right and left eyes Best corrected acuity of 20/25 or better in each eye Self report of at least 4 hrs/day using digital devices Current/established soft contact lens wearer (has worn contact lenses in the past year)

Exclusion An optometrist or optometry student History of ocular pathology or surgery Binocular vision disorder (i.e., tropia, convergence or accommodative insufficiency) Gas permeable lens wear for at least 3 months Presbyopic (based on refraction)

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• Dailies Aqua Comfort Plus Toric
Daily disposable soft toric contact lens
• Dailies Aqua Comfort Plus Sphere
Daily disposable soft spherical contact lens

Locations

Country	Name	City	State
United States	University of Houston College of Optometry	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Near Visual LogMAR Acuity	High contrast LogMAR visual acuity was assessed at 40 cm using the M&S Clinical Trial Suite system (Niles, Illinois, USA). The system was calibrated according to the manufacturer's directions every day, prior to use. Testing was performed binocularly. The test started at 20/200 and continued until three letters were missed on a line.	10 +/- 2 days