Dry EyeNCT05973409
Evaluation of Onefit Scleral Lenses in the Mangement of Dry Eye
A study testing scleral lens in people with Dry Eye, run by CooperVision International Limited (CVIL) at 1 site in Canada.
Trial summary
This study is being conducted to determine if scleral lenses treated with Hydra-PEG improve comfort and dryness. Read more about this study
- Who is it for?
- Ages 17 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- scleral lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteCanada
- Study dates
- 26 Sep 2022to 15 Aug 2023
- 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 17 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Are at least 17 years of age and have full legal capacity to volunteer;
- Have read and signed an information consent letter;
- Are willing and able to follow instructions and maintain the appointment schedule;
- Agree to wear the study scleral lenses for at least 8 hours per day, 5 days a week;
- Have a refraction between +20.00 and -20.00D and spectacle astigmatism of no more than -3.00DC in each eye;
- Have best corrected visual acuity of 20/40 or better in each eye with the study lenses;
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- Demonstrate an acceptable fit with the study lenses;
- Have no active ocular disease or inflammation;
- Group 1: Habitual wearer of frequent replacement or daily disposable soft lenses;
- Group 2: Have not worn contact lenses for 6 months;
- Group 1: Contact lens wearers should score ≥12 on CLDEQ-8;
- Group 2: Non contact lens wearers should score ≥13 on OSDI.
Who cannot join
- Are participating in any concurrent clinical or research study, or have done so within the past 30 days;
- Cannot achieve a successful lens fit or vision with the study lens;
- Have been diagnosed with keratoconus or corneal distortion;
- Have any known active* ocular condition, disease and/or infection;
- Have a systemic or ocular condition that in the opinion of the investigator may affect a study outcome variable e.g. pingueculae;
- Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
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- Group 2: Non-contact lens wearers who score ≥33 on OSDI and also demonstrate either corneal staining ≥3 (Oxford scale) or non-invasive tear break-up time ≤3 seconds#;
- Have known sensitivity to the diagnostic sodium fluorescein to be used in the study;
- Are pregnant, lactating or planning a pregnancy^ at the time of enrolment, by self report;
- Have undergone refractive error surgery;
- Are listed on the Delegation Log for this study.
Trial locations and contacts
1 site in 1 country.
About this study
This study is being conducted to determine if scleral lenses treated with Hydra-PEG improve comfort and dryness.
Read the detailed description
The objective of the study is to determine if scleral lenses with and scleral lenses without Hydra-PEG treatment provide positive improvement in ocular comfort and dryness scores.
The effect of the study lenses and the treatment, will be compared in a group of symptomatic soft lens wearers, and also in a group of symptomatic non contact lens wearers.
The primary outcome variable for this study is "overall ocular comfort" reported at the screening visit for the habitual vision correction, and at the 4-week follow-up visits for each of the two study lenses. using a 0-10 scale (0.5 steps).
- Conditions
- Dry Eye
- Being tested
- scleral lens
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scleral lensDevice
scleral lens with and without hydra-peg treatment
| Study group | Role | What they receive |
|---|---|---|
| Habitual Soft Lens Wearers | Experimental | Each group will be a prospective, randomized, double masked, cross-over, 1-month per arm, daily wear study. Each participant will be active in the study for at least 2 months. Receives: Device: scleral lens |
| Non Contact Lens Wearers | Experimental | Each group will be a prospective, randomized, double masked, cross-over, 1-month per arm, daily wear study. Each participant will be active in the study for at least 2 months. Receives: Device: scleral lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall ocular comfort
reported at the screening visit for the habitual vision correction, and at the 4-week follow-up visits for each of the two study lenses. using a 0-10 scale (0.5 steps)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start26 Sep 2022
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision International Limited (CVIL)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lyndon Jones, PhD, Principal investigator, Director, Centre for Ocular Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973409
- Sponsor's protocol ID
- SEC-P052021
- Status last verified
- Apr 2026
- First submitted
- 23 Mar 2023
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Onefit Scleral Lenses in the Mangement of Dry Eye
- ClinicalTrials.gov ID
- NCT05973409
- Acronym / sponsor ID
- SEC-P052021
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- CooperVision International Limited (CVIL)Industry (pharma, biotech, devices)
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 2 Aug 2023 (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 is being conducted to determine if scleral lenses treated with Hydra-PEG improve comfort and dryness.
Detailed description
The objective of the study is to determine if scleral lenses with and scleral lenses without Hydra-PEG treatment provide positive improvement in ocular comfort and dryness scores.
The effect of the study lenses and the treatment, will be compared in a group of symptomatic soft lens wearers, and also in a group of symptomatic non contact lens wearers.
The primary outcome variable for this study is "overall ocular comfort" reported at the screening visit for the habitual vision correction, and at the 4-week follow-up visits for each of the two study lenses. using a 0-10 scale (0.5 steps).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Habitual Soft Lens Wearers | Experimental | Device: scleral lensEach group will be a prospective, randomized, double masked, cross-over, 1-month per arm, daily wear study. Each participant will be active in the study for at least 2 months. |
| Non Contact Lens Wearers | Experimental | Device: scleral lensEach group will be a prospective, randomized, double masked, cross-over, 1-month per arm, daily wear study. Each participant will be active in the study for at least 2 months. |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Are at least 17 years of age and have full legal capacity to volunteer;
- Have read and signed an information consent letter;
- Are willing and able to follow instructions and maintain the appointment schedule;
- Agree to wear the study scleral lenses for at least 8 hours per day, 5 days a week;
- Have a refraction between +20.00 and -20.00D and spectacle astigmatism of no more than -3.00DC in each eye;
Key exclusion criteria (11 listed)
- Are participating in any concurrent clinical or research study, or have done so within the past 30 days;
- Cannot achieve a successful lens fit or vision with the study lens;
- Have been diagnosed with keratoconus or corneal distortion;
- Have any known active* ocular condition, disease and/or infection;
- Have a systemic or ocular condition that in the opinion of the investigator may affect a study outcome variable e.g. pingueculae;
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 |
|---|---|---|
| scleral lensscleral lens with and without hydra-peg treatment | Device | Habitual Soft Lens Wearers, Non Contact Lens Wearers |
Primary outcome
overall ocular comfort
Time frame: 4 weeks
reported at the screening visit for the habitual vision correction, and at the 4-week follow-up visits for each of the two study lenses. using a 0-10 scale (0.5 steps)
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 17 Apr 2026.
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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.
Lyndon Jones, PhD principal investigator
Director, Centre for Ocular Research and Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing scleral lens in people with Dry Eye, run by CooperVision International Limited (CVIL) at 1 site in Canada.
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 12 inclusion and 11 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 17 Apr 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 Canada. 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 ocular comfort (time frame: 4 weeks). 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 17 Apr 2026.