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
- Are there results?
- None posted in the registry
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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Rotational Behavior of Soft Toric Contact Lenses With Different Stabilization Designs and Their Association With Ocular Biometric Parameters
- ClinicalTrials.gov ID
- NCT07795671
- Acronym / sponsor ID
- TORIC-ROT-2026-01
- Conditions
- Astigmatism
- Keywords
- toric contact lens, rotational stability, lens rotation, stabilization design, ocular biometry, soft contact lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bozok UniversityUniversity, hospital or other
- Study start
- 2 May 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ASD First, Modified Periballast Second | Other | Device: Acuvue Oasys for Astigmatism, Device: Air Optix for AstigmatismParticipants 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. |
| Modified Periballast First, ASD Second | Other | Device: Acuvue Oasys for Astigmatism, Device: Air Optix for AstigmatismParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- History of corneal pathology
- Previous ocular surgery
- Active ocular disease
- Systemic disease affecting the eyes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acuvue Oasys for AstigmatismCommercially 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 | ASD First, Modified Periballast Second, Modified Periballast First, ASD Second |
| Air Optix for AstigmatismCommercially 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. | Device | ASD First, Modified Periballast Second, Modified Periballast First, ASD Second |
Primary outcome
Overall Mean Absolute Contact Lens Rotation
Time frame: 30 minutes after lens insertion during each fitting session
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Mean Absolute Contact Lens Rotation (time frame: 30 minutes after lens insertion during each fitting session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.