Toric Contact Lens Performance Study

Not Applicable

Completed

• Conditions: Astigmatism
• Interventions: Device: Dailies Aqua Comfort Plus Toric; Device: Dailies Aqua Comfort Plus Sphere

• Registration Number: NCT03546647
• Lead Sponsor: University of Houston

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-05-18
• Study First Submitted QC: 2018-06-01
• Study First Posted: 2018-06-06
• Study Start: 2018-06-18
• Primary Completion: 2018-12-21
• Study Completion: 2018-12-21
• Results First Submitted: 2021-01-07
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-04
• Last Update Submitted: 2021-06-04
• Results First Posted: 2021-06-07
• Last Update Posted: 2021-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Toric, Then Sphere	Dailies Aqua Comfort Plus Sphere	Participants who received Toric contact lenses first and spherical lenses after 10 days
Toric, Then Sphere	Dailies Aqua Comfort Plus Toric	Participants who received Toric contact lenses first and spherical lenses after 10 days
Sphere, Then Toric	Dailies Aqua Comfort Plus Sphere	Participants who received Spherical contact lenses first and Toric lenses after 10 days
Sphere, Then Toric	Dailies Aqua Comfort Plus Toric	Participants who received Spherical contact lenses first and Toric lenses after 10 days

Primary Outcome Measures

Name	Time	Method
Near Visual LogMAR Acuity	10 +/- 2 days	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.

Trial Locations

Locations (1)

University of Houston College of Optometry; 🇺🇸 Houston, Texas, United States