Rotational Stability of Two Soft Toric Contact Lens Designs

Comparison of Rotational Behavior of Soft Toric Contact Lenses With Different Stabilization Designs and Their Association With Ocular Biometric Parameters

This study compared the rotational behavior of two commercially available soft toric contact lenses with different stabilization designs and explored whether ocular biometric and refractive characteristics were associated with lens rotation. Contact lens-naïve adults underwent baseline ocular biometry and were scheduled for two separate lens-fitting sessions in randomized order. Lens rotation was measured 30 minutes after insertion in primary, right, left, upward, and downward gaze using slit-lamp biomicroscopy. The study was designed as a two-period crossover comparison.

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: Acuvue Oasys for Astigmatism; Device: Air Optix for Astigmatism

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Yozgat
    • Yozgat, Yozgat, Turkey (Türkiye), 66100
      • Yozgat Bozok University Research and Application Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults with astigmatic refractive error suitable for correction with the -commercially available toric contact lenses used in the study
• No prior experience with contact lens wear
• Healthy ocular surface examination
• Ability and willingness to provide written informed consent

Exclusion Criteria:

• History of corneal pathology
• Previous ocular surgery
• Active ocular disease
• Systemic disease affecting the eyes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ASD First, Modified Periballast Second; Participants received the accelerated stabilization design lens at the first fitting session and the modified periballast lens at the second fitting session after a 4-day interval.	Device: Acuvue Oasys for Astigmatism; Commercially available soft toric contact lens composed of senofilcon A, with an 8.6-mm base curve and 14.5-mm diameter, using an accelerated stabilization design.; Device: Air Optix for Astigmatism; Commercially available soft toric contact lens composed of lotrafilcon B, with an 8.7-mm base curve and 14.5-mm diameter, using a modified periballast stabilization design.
Other: Modified Periballast First, ASD Second; Participants received the modified periballast lens at the first fitting session and the accelerated stabilization design lens at the second fitting session after a 4-day interval.	Device: Acuvue Oasys for Astigmatism; Commercially available soft toric contact lens composed of senofilcon A, with an 8.6-mm base curve and 14.5-mm diameter, using an accelerated stabilization design.; Device: Air Optix for Astigmatism; Commercially available soft toric contact lens composed of lotrafilcon B, with an 8.7-mm base curve and 14.5-mm diameter, using a modified periballast stabilization design.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Mean Absolute Contact Lens Rotation	Absolute lens rotation was measured in degrees using slit-lamp biomicroscopy in five gaze positions (primary, right, left, upward, and downward gaze). For each lens design, the overall mean absolute rotation was calculated as the average of the absolute rotation measurements across the five gaze positions.	30 minutes after lens insertion during each fitting session

Collaborators and Investigators

• Sponsor: Bozok University

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2026
• Primary Completion (Actual): July 1, 2026
• Study Completion (Actual): July 1, 2026

Study Registration Dates

• First Submitted: August 26, 2026
• First Submitted That Met QC Criteria: August 26, 2026
• First Posted (Actual): August 31, 2026

Study Record Updates

• Last Update Posted (Actual): September 1, 2026
• Last Update Submitted That Met QC Criteria: August 29, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: soft contact lens; rotational stability; toric contact lens; ocular biometry; lens rotation; stabilization design
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: TORIC-ROT-2026-01; 2026-GOKAEK-267_2026.04.01_98 (Other Identifier: Yozgat Bozok University Clinical Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying the results reported in the published article, including demographic, refractive, ocular biometric, and contact lens rotation measurements, may be shared upon reasonable request. No directly identifying information will be provided.
• IPD Sharing Time Frame: Data will be available beginning after publication of the primary study results and will remain available for 5 years following publication.
• IPD Sharing Access Criteria: Data may be provided to qualified researchers who submit a methodologically sound scientific proposal to the corresponding author. Requests will be evaluated for scientific purpose, participant confidentiality, applicable ethical and institutional requirements, and compatibility with the original informed consent. A data use agreement may be required where appropriate.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No