Healthy Participants StudyFLOSSNCT06745375
Assessment of the Relationship of Soft Contact Lens Fit and Power (Fit & Lens pOwer Soft lenSes)
A study testing contact lens wear in people with Healthy Participants Study and Contact Lens Wear, run by Aston University at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate whether altering the optical power (in dioptres) of a contact lens affects both vision and lens fit. As the majority of modern contact lens wearers prefer daily disposable soft lenses, the trial lenses used in this study-provided by CooperVision-reflect this trend, representing… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants Study, Contact Lens Wear, Contact Lens Fit
- What is being tested?
- contact lens wear
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jan 2026to 31 Dec 2026
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18-60 years of age
- Vision correctable to at least 6/12 (20/40) or better in each eye
- with mental capacity to provide written consent in English (as per the Mental Capacity Act, 2005).
- happy to wear investigational contact lenses
Who cannot join
- Any active infection or inflammation, history of major systemic or ophthalmic conditions
- use of systemic or topical medications known to affect the eye in the previous 3 months
- history of ocular surgery, currently enrolled on another study/clinical trial that may impact outcome
- any other contraindications for typical contact lens wear
- As per the Mental Capacity Act, 2005, participants will be automatically excluded if not deemed to have Capacity for consent or under the age of 18.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
School of Optometry, Aston Eye Clinic
Birmingham, UK, B4 7ET
About this study
Official title: Evaluation of the Vision and Fit of Commercially Available Correct Powered (Prescription) Contact Lenses Compared to Lenses Within a Range of ± 2.00 Dioptres (Strength/Power of Lens) From the Prescription
The purpose of this study is to evaluate whether altering the optical power (in dioptres) of a contact lens affects both vision and lens fit. As the majority of modern contact lens wearers prefer daily disposable soft lenses, the trial lenses used in this study-provided by CooperVision-reflect this trend, representing nearly 80% of the current UK market.
This study aims to generate data supporting the use of contact lenses with powers that do not precisely match a participant's visual prescription (within ±2.00 dioptres) as a viable temporary alternative when the exact required power is unavailable.
At present, there is no published literature in the context of modern contact lens design that compares the fitting characteristics of 'fit-for-purpose' lenses with those of lenses from the same design family that would not typically be selected due to power mismatch.
Read the detailed description
This study aims to evaluate the vision and fit of commercially available prescription contact lenses of different strengths to determine whether this affects the final lens selection and, if so, how. In addition, the study will compare subjective comfort and key fitting criteria such as centration, movement, tightness, coverage, and overall impression.
These data could help eye care practitioners use lenses they already have in stock instead of ordering new ones and requiring patients to return. Understanding whether these lenses fit similarly could make the process more convenient for both patients and practitioners. Patients would receive their lenses more quickly, and eye care providers could manage their existing stock more effectively.
The two visits will take place at the Aston University Eye Clinic. Data collection and assessments will include:
Participant's age, ethnicity, sex, and ocular history to determine eligibility [recorded electronically on a secure computer].
A standardised OSDI questionnaire (paper copy only), which quantifies dry eye symptoms, severity, and frequency (e.g. in the past week, how often participants' eyes felt gritty, watery, itchy, or burning, and how many times they experienced these symptoms), will be administered at the first visit after written consent. The completed questionnaire will be scanned and uploaded to BOX.
Both Visit One and Visit Two will include:
Application of contact lenses to the participant's eyes. Lens powers will be randomised between visits for each participant.
Comfort assessment using:
A visual analogue scale (paper-based) from "most comfortable" to "least comfortable," where participants mark their comfort level.
A numerical rating (1-10) of comfort, recorded electronically. Vision assessment after lens application, both objectively (autorefractor) and subjectively, as in routine clinical practice.
A video-recorded ocular assessment of the contact lens fit, including horizontal lens movement, blink-induced movement, and lens centration.
After data collection is complete and the lenses are removed at Visit Two, participants will be asked which lenses they preferred [recorded electronically].
The data collection follows standardised contact lens assessment protocols used in both primary and secondary care optometry.
A participant's current eye care practitioner will not be informed of their participation or the corresponding assessments/data unless clinically significant findings are discovered and the participant consents to sharing this information. Participants will be informed of the lens brand and manufacturer used in the study so that, if they find the lenses more comfortable than their current ones (if applicable) or are considering contact lenses, they may discuss this with their eye care practitioner.
- Being tested
- contact lens wear
- Keywords
- contact lens, contact lens wear, contact lens fit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contact lens wearDevice
participants wear two different powered contact lenses (one with actual power, and one +/- 2.00Ds) contact lenses. No 2nd arm
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | Experimental | All healthy participants wear two different contact lenses, one with the correct power and one with +/- 2.00 Ds to actual refraction. All lenses are commercially available. No 2nd arm. Receives: Device: contact lens wear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft contact lens movement: Subjective and objective assessment of soft contact lens movement.
Lens movements will be graded between 0.25 - 0.50 mm = Optimum, <0.25 = Less movement; >0.50mm is more movement.
Measured: within 30 mins of lens wear
Soft contact lens horizontal lag:Subjective and objective assessment of soft contact lens lag.
Lens lag will be graded as: <50% lag = less leg, 50% to 100% is optimum lag, >100% = high lag.
Measured: within 30 mins of lens wear
Soft contact lens tightness: graded subjectively as optimum, loose and tight
Soft contac tlens tightness
Measured: within 30 mins of lens wear
Secondary outcomes (1)
Assessment of ocular comfort with soft contact lenses
Ocular comfort is graded by particpants 1-10 (1 being very uncomfortable and 10 being highly comfortable)
Measured: within 30 mins of lens wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start30 Jan 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Participants StudyStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This crossover study compares patients' actual prescription contact lenses with lenses ±2.00 dioptres to assess differences in fit. Key fitting metrics include lens movement (\<1.00 mm), coverage, and push-up tests. Using G\*Power (v3.1.9.4), a sample size of 38 was calculated. The study uses paired assessments (same participant wears both lenses) to evaluate lens movement in mm. Literature reports mean ± SD of 0.352 ± 0.355 mm and 0.269 ± 0.179 mm, with high correlation (r = 0.95) (Belda-Salmerón et al.). A clinically significant difference is set at 0.25 mm. To achieve 80% power with a 5% Type I error and accounting for a 10% dropout rate, 38 participants are required.
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aston University
- Sponsor type
- University, hospital or other
- Collaborators
- CooperVision, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745375
- Sponsor's protocol ID
- HLS21201
- Acronym
- FLOSS
- Status last verified
- Jan 2026
- First submitted
- 9 Dec 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This has not been planned, yet but there is no reason cant be done by the end of study.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Vision and Fit of Commercially Available Correct Powered (Prescription) Contact Lenses Compared to Lenses Within a Range of ± 2.00 Dioptres (Strength/Power of Lens) From the Prescription
- ClinicalTrials.gov ID
- NCT06745375
- Acronym / sponsor ID
- FLOSS / HLS21201
- Keywords
- contact lens, contact lens wear, contact lens fit
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Aston UniversityUniversity, hospital or other
- Collaborators
- CooperVision, Inc.
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Dec 2024 (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.
The purpose of this study is to evaluate whether altering the optical power (in dioptres) of a contact lens affects both vision and lens fit. As the majority of modern contact lens wearers prefer daily disposable soft lenses, the trial lenses used in this study-provided by CooperVision-reflect this trend, representing nearly 80% of the current UK market.
This study aims to generate data supporting the use of contact lenses with powers that do not precisely match a participant's visual prescription (within ±2.00 dioptres) as a viable temporary alternative when the exact required power is unavailable.
At present, there is no published literature in the context of modern contact lens design that compares the fitting characteristics of 'fit-for-purpose' lenses with those of lenses from the same design family that would not typically be selected due to power mismatch.
Detailed description
This study aims to evaluate the vision and fit of commercially available prescription contact lenses of different strengths to determine whether this affects the final lens selection and, if so, how. In addition, the study will compare subjective comfort and key fitting criteria such as centration, movement, tightness, coverage, and overall impression.
These data could help eye care practitioners use lenses they already have in stock instead of ordering new ones and requiring patients to return. Understanding whether these lenses fit similarly could make the process more convenient for both patients and practitioners. Patients would receive their lenses more quickly, and eye care providers could manage their existing stock more effectively.
The two visits will take place at the Aston University Eye Clinic. Data collection and assessments will include:
Participant's age, ethnicity, sex, and ocular history to determine eligibility [recorded electronically on a secure computer].
A standardised OSDI questionnaire (paper copy only), which quantifies dry eye symptoms, severity, and frequency (e.g. in the past week, how often participants' eyes felt gritty, watery, itchy, or burning, and how many times they experienced these symptoms), will be administered at the first visit after written consent. The completed questionnaire will be scanned and uploaded to BOX.
Both Visit One and Visit Two will include:
Application of contact lenses to the participant's eyes. Lens powers will be randomised between visits for each participant.
Comfort assessment using:
A visual analogue scale (paper-based) from "most comfortable" to "least comfortable," where participants mark their comfort level.
A numerical rating (1-10) of comfort, recorded electronically. Vision assessment after lens application, both objectively (autorefractor) and subjectively, as in routine clinical practice.
A video-recorded ocular assessment of the contact lens fit, including horizontal lens movement, blink-induced movement, and lens centration.
After data collection is complete and the lenses are removed at Visit Two, participants will be asked which lenses they preferred [recorded electronically].
The data collection follows standardised contact lens assessment protocols used in both primary and secondary care optometry.
A participant's current eye care practitioner will not be informed of their participation or the corresponding assessments/data unless clinically significant findings are discovered and the participant consents to sharing this information. Participants will be informed of the lens brand and manufacturer used in the study so that, if they find the lenses more comfortable than their current ones (if applicable) or are considering contact lenses, they may discuss this with their eye care practitioner.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This crossover study compares patients' actual prescription contact lenses with lenses ±2.00 dioptres to assess differences in fit. Key fitting metrics include lens movement (<1.00 mm), coverage, and push-up tests. Using G*Power (v3.1.9.4), a sample size of 38 was calculated. The study uses paired assessments (same participant wears both lenses) to evaluate lens movement in mm. Literature reports mean ± SD of 0.352 ± 0.355 mm and 0.269 ± 0.179 mm, with high correlation (r = 0.95) (Belda-Salmerón et al.). A clinically significant difference is set at 0.25 mm. To achieve 80% power with a 5% Type I error and accounting for a 10% dropout rate, 38 participants are required.
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | Experimental | Device: contact lens wearAll healthy participants wear two different contact lenses, one with the correct power and one with +/- 2.00 Ds to actual refraction. All lenses are commercially available. No 2nd arm. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between 18-60 years of age
- Vision correctable to at least 6/12 (20/40) or better in each eye
- with mental capacity to provide written consent in English (as per the Mental Capacity Act, 2005).
- happy to wear investigational contact lenses
Key exclusion criteria (5 listed)
- Any active infection or inflammation, history of major systemic or ophthalmic conditions
- use of systemic or topical medications known to affect the eye in the previous 3 months
- history of ocular surgery, currently enrolled on another study/clinical trial that may impact outcome
- any other contraindications for typical contact lens wear
- As per the Mental Capacity Act, 2005, participants will be automatically excluded if not deemed to have Capacity for consent or under the age of 18.
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 |
|---|---|---|
| contact lens wearparticipants wear two different powered contact lenses (one with actual power, and one +/- 2.00Ds) contact lenses. No 2nd arm | Device | Healthy participants |
Primary outcome
Soft contact lens movement: Subjective and objective assessment of soft contact lens movement.
Time frame: within 30 mins of lens wear
Lens movements will be graded between 0.25 - 0.50 mm = Optimum, <0.25 = Less movement; >0.50mm is more movement.
Soft contact lens horizontal lag:Subjective and objective assessment of soft contact lens lag.
Time frame: within 30 mins of lens wear
Lens lag will be graded as: <50% lag = less leg, 50% to 100% is optimum lag, >100% = high lag.
Soft contact lens tightness: graded subjectively as optimum, loose and tight
Time frame: within 30 mins of lens wear
Soft contac tlens tightness
1 secondary outcome
Assessment of ocular comfort with soft contact lenses
Time frame: within 30 mins of lens wear
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 21 Jan 2026.
- Individual participant dataSharing planned: Undecided. This has not been planned, yet but there is no reason cant be done by the end of study.
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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.
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 contact lens wear in people with Healthy Participants Study and Contact Lens Wear, run by Aston University at 1 site in United Kingdom.
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 5 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: enrolling by invitation, as of the sponsor's last update on 21 Jan 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 United Kingdom. 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?
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?
Soft contact lens movement: Subjective and objective assessment of soft contact lens movement. (time frame: within 30 mins of lens wear). The study lists 3 primary outcomes in all. 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 21 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.