Rotational Stability of Two Soft Toric Contact Lens Designs

NCT07795671 | Completed

• 2 other identifiers: TORIC-ROT-2026-012026-GOKAEK-267_2026.04.01_98
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Astigmatism

Keywords

toric contact lens; rotational stability; lens rotation; stabilization design; ocular biometry; soft contact lens

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

ASD First, Modified Periballast Second

OTHER

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; Device: Air Optix for Astigmatism

Modified Periballast First, ASD Second

OTHER

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; Device: Air Optix for Astigmatism

Interventions

Acuvue Oasys for Astigmatism DEVICE

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.

ASD First, Modified Periballast Second; Modified Periballast First, ASD Second

Air Optix for Astigmatism DEVICE

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.

ASD First, Modified Periballast Second; Modified Periballast First, ASD Second

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bozok University: lead

Study Sites (1)

Yozgat Bozok University Research and Application Hospital

Yozgat, Yozgat, 66100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Ophthalmology

Model Details: Participants were scheduled to receive both soft toric contact lens designs in two separate fitting sessions, with the order of lens application randomized by a simple draw of lots. The two sessions were separated by a 4-day interval. Because 16 participants did not attend the second session, the intended two-period crossover design was incomplete.

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: May 2, 2026
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available beginning after publication of the primary study results and will remain available for 5 years following publication.
• 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.

Locations

TU (1)