AstigmatismNCT07795671
Rotational Stability of Two Soft Toric Contact Lens Designs
A study testing Acuvue Oasys for Astigmatism and Air Optix for Astigmatism in people with Astigmatism, run by Bozok University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Astigmatism
- What is being tested?
- Acuvue Oasys for Astigmatism and Air Optix for Astigmatism
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2026to 1 Jul 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- History of corneal pathology
- Previous ocular surgery
- Active ocular disease
- Systemic disease affecting the eyes
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yozgat Bozok University Research and Application Hospital
Yozgat, Yozgat, 66100
About this study
Official title: 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.
- Conditions
- Astigmatism
- Being tested
- Acuvue Oasys for Astigmatism, Air Optix for Astigmatism
- Keywords
- toric contact lens, rotational stability, lens rotation, stabilization design, ocular biometry, soft contact lens
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acuvue Oasys for AstigmatismDevice
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.
Air Optix for AstigmatismDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Acuvue Oasys for Astigmatism; Device: Air Optix for Astigmatism |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes after lens insertion during each fitting session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start2 May 2026
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstigmatismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozok University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koçer Furkan Durukan, Bozok University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795671
- Sponsor's protocol ID
- TORIC-ROT-2026-01
- Other IDs
- 2026-GOKAEK-267_2026.04.01_98
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.