Contact Lens ComfortNCT06955403
Acuvue Oaysis Contact Lens Wearers Being Refit Into P7 Contact Lenses
A study testing Precision 7 contact lenses in people with Contact Lens Comfort, run by Southern College of Optometry at 1 site in United States.
Trial summary
Determine the likelihood of successfully refitting a satisfied AOA CL wearers into P7A CLs Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Contact Lens Comfort
- What is being tested?
- Precision 7 contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- - Have presbyopia and/or need a reading add as determined during their initial manifest refraction
- Have worn P7A in the past
- Are past rigid CL wearers
- Have a history of being diagnosed with dry eye or ocular allergies
- Have known systemic health conditions that are thought to alter tear film physiology
- Have a history of viral eye disease
Show all 12Show fewer
- Have a history of ocular surgery
- Have a history of severe ocular trauma
- Have a history of corneal dystrophies or degenerations
- Have active ocular infection or inflammation
- Are currently using isotretinoin-derivatives or ocular medications
- Are pregnant or breast feeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Southern College of Optometry
Memphis, Tennessee, 38104
Chris Lievens, OD, 9014815699, clievens@sco.edu
About this study
Official title: How Does PRECISION7® for Astigmatism Perform in Current and Successful Acuvue® Oasys for Astigmatism Wearers?
Determine the likelihood of successfully refitting a satisfied AOA CL wearers into P7A CLs
Read the detailed description
PRECISION7m for Astigmatism is a 1-week, silicone hydrogel (serafilcon A), daily wear, contact lens (CL) with extended wear approval made of a novel material that incorporates the Activ-Flo System. The Activ-Flo System has a moisturizing agent within the CL matrix, which allows for continual release of the moisturizing agents while also providing up to 16 hours of comfortable wear and precise vision for the life of the CL. While initial P7A data are promising, the literature currently lacks a targeted study aimed at determining how patients perform in P7A after transitioning out of other commonly prescribed silicone hydrogel CLs. This transition could be particularly important for patients who have astigmatism given that they tend to struggle with CLs more than spherical CL wearers.1 Thus, the purpose of this study is to determine the success rate of refitting current, satisfied ACUVUE OASYS for Astigmatism CL wearers into P7A. Understanding how a P7A CL wearer reacts to transitioning into P7A from AOA will provide valuable information to partitioners for patient educational purposes, and it will provide credence for refitting successful AOA patients into the newer P7A technology, which could help grow the P7A CL market by not limiting P7A refits to problem-solving events.
- Conditions
- Contact Lens Comfort
- Being tested
- Precision 7 contact lenses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precision 7 contact lensesDevice
Acuvue Oaysis contact lens wearers have will be refit into precision 7 contact lenses.
| Study group | Role | What they receive |
|---|---|---|
| PRECISION7 | Experimental | Determine the likelihood of successfully refitting a satisfied Acuvue Oaysis Contact Lens wearers into P7A CLs. Receives: Device: Precision 7 contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Likert questionnaire
- Likelihood of continuing to wear P7A, 2. Overall satisfaction while wearing P7A, 3. Overall vision while wearing P7A, 4. End of day comfort while wearing P7A, 5. End of day vision while wearing P7A, 6. Overall comfort while wearing P7A, 7. Ability to play sports and perform fitness actives while wearing P7A, 8. Ability to use digital devices while wearing P7A (questions attached). 9. Would recommend the study CLs to a friend.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start15 Apr 2025
- Primary completion31 Aug 2025
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact Lens ComfortStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This will be a prospective study to understand if satisfied AOA CL wearers can be successfully refit into P7A CLs. The Primary Endpoint will be analyzed as the proportion of participants who have CLDEQ-8 scores \<12 at the end of the study; thus, no comparison will occur with the Primary Endpoint and no formal sample size calculation can be performed
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern College of Optometry
- Sponsor type
- University, hospital or other
- Collaborators
- Eminent Ophthalmic Services
- Responsible party
- Sponsor
- Investigators
- Chris Lievens, Principal investigator, The Southern College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955403
- Sponsor's protocol ID
- P7
- Status last verified
- Nov 2025
- First submitted
- 24 Apr 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does PRECISION7® for Astigmatism Perform in Current and Successful Acuvue® Oasys for Astigmatism Wearers?
- ClinicalTrials.gov ID
- NCT06955403
- Acronym / sponsor ID
- P7
- Conditions
- Contact Lens Comfort
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Southern College of OptometryUniversity, hospital or other
- Collaborators
- Eminent Ophthalmic Services
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 2 May 2025 (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.
Determine the likelihood of successfully refitting a satisfied AOA CL wearers into P7A CLs
Detailed description
PRECISION7m for Astigmatism is a 1-week, silicone hydrogel (serafilcon A), daily wear, contact lens (CL) with extended wear approval made of a novel material that incorporates the Activ-Flo System. The Activ-Flo System has a moisturizing agent within the CL matrix, which allows for continual release of the moisturizing agents while also providing up to 16 hours of comfortable wear and precise vision for the life of the CL. While initial P7A data are promising, the literature currently lacks a targeted study aimed at determining how patients perform in P7A after transitioning out of other commonly prescribed silicone hydrogel CLs. This transition could be particularly important for patients who have astigmatism given that they tend to struggle with CLs more than spherical CL wearers.1 Thus, the purpose of this study is to determine the success rate of refitting current, satisfied ACUVUE OASYS for Astigmatism CL wearers into P7A. Understanding how a P7A CL wearer reacts to transitioning into P7A from AOA will provide valuable information to partitioners for patient educational purposes, and it will provide credence for refitting successful AOA patients into the newer P7A technology, which could help grow the P7A CL market by not limiting P7A refits to problem-solving events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This will be a prospective study to understand if satisfied AOA CL wearers can be successfully refit into P7A CLs. The Primary Endpoint will be analyzed as the proportion of participants who have CLDEQ-8 scores <12 at the end of the study; thus, no comparison will occur with the Primary Endpoint and no formal sample size calculation can be performed
| Arm | Type | Receives |
|---|---|---|
| PRECISION7 | Experimental | Device: Precision 7 contact lensesDetermine the likelihood of successfully refitting a satisfied Acuvue Oaysis Contact Lens wearers into P7A CLs. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- - Have presbyopia and/or need a reading add as determined during their initial manifest refraction
- Have worn P7A in the past
- Are past rigid CL wearers
- Have a history of being diagnosed with dry eye or ocular allergies
- Have known systemic health conditions that are thought to alter tear film physiology
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 |
|---|---|---|
| Precision 7 contact lensesAcuvue Oaysis contact lens wearers have will be refit into precision 7 contact lenses. | Device | PRECISION7 |
Primary outcome
Likert questionnaire
Time frame: 1 week
1. Likelihood of continuing to wear P7A, 2. Overall satisfaction while wearing P7A, 3. Overall vision while wearing P7A, 4. End of day comfort while wearing P7A, 5. End of day vision while wearing P7A, 6. Overall comfort while wearing P7A, 7. Ability to play sports and perform fitness actives while wearing P7A, 8. Ability to use digital devices while wearing P7A (questions attached). 9. Would recommend the study CLs to a friend.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
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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.
Chris Lievens principal investigator
The Southern College of Optometry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Precision 7 contact lenses in people with Contact Lens Comfort, run by Southern College of Optometry at 1 site in United States.
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 0 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 26 Nov 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chris Lievens, OD (9014815699, clievens@sco.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Likert questionnaire (time frame: 1 week). 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 26 Nov 2025.