MyopiaNCT07091825
Evaluating the Efficacy and Safety of Contact Lens Lubricant in Rigid Gas Permeable Corneal Contact Lens Wearers
A study testing LACRIFRESH OCU-DRY 0.3% OSD and Rigid contact lens lubricant in people with Myopia, run by Avizor SA at 3 sites in China.
Trial summary
This trial aims to evaluate the safety and effectiveness of LACRIFRESH OCU-DRY 0.3% OSD, a contact lens lubricant produced by AVIZOR, S.A. This clinical trial adopts a Multi-center, randomized, open-label, positive parallel-controlled design in accordance with the principles outlined in the Norms on the Quality… Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- LACRIFRESH OCU-DRY 0.3% OSD and Rigid contact lens lubricant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 3 sitesChina
- Study dates
- 27 Jun 2025to 30 Jun 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged 8 and older, no gender limitation;
- Rigid gas permeable corneal contact lens (OK lens) wearers;
- The best corrected distance visual acuity of framed lenses in both eyes can reach 5.0 (5-Point Scale);
- Be able and willing to comply with all treatments and follow-ups;
- Be able to understand the purpose of the trial, participate voluntarily and have ICF signed by the subject himself/herself or his/her legal guardian.
Who cannot join
- Patients with only one eye meeting the inclusion criteria.
- Patients with abnormal clinical abnormalities or systemic diseases affecting the eyes that occurred or is occurring before screening and, in the investigator's judgment, preclude the use of corneal contact lenses.
- Patients with some eye diseases that affect contact lens wearing: such as acute or chronic eye diseases, conjunctivitis catarrhalis aestiva, glaucoma, corneal abnormalities, keratoconus, etc.
- Patients with allergies to the components of contact lens or contact lens care solution involved in this trial;
- Patients who are using or need to use drugs that may cause dry eyes or affect vision and corneal curvature (e.g. immunosuppressant, glucocorticoids, IOP-lowering drugs, low concentration atropine) during the study;
- Patients with a history of intraocular operation;
Show all 13Show fewer
- Patients with abnormal IOP (the single eye IOP <10 mmHg or >21mmHg, or the IOP difference of both eyes >5mmHg), obvious fundus abnormalities, examination of corneal endothelial cell (abnormal ≥ Level 4), or slit-lamp examination abnormalities.
- Patients with dry eye syndrome or with break up time (BUT) <5s.
- Subjects who participated in other drug clinical trials within 90 days before screening, and participated in other medical device clinical trials within 30 days;
- Patients who wore rigid contact lens (including orthokeratology lens) within the past 30 days;
- Patients who are pregnant, nursing or planning to conceive at the enrollment;
- Patients with contraindications for wearing rigid contact lenses or unsuitable for wearing rigid contact lenses as indicated by examination results;
- Other conditions for which the investigator judged the patient unsuitable for inclusion.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Beijing Aier Intech Eye Hospital
Beijing, Beijing Municipality, 100021
Chunlei Fan, +86 10 67715558, eye010bjkjb@163.com
- Recruiting
Tianjin Eye Hospital
Tianjin, Tianjin Municipality, 300020
Lihua Li, +86 137 5200 7098, tysgzxlccs@163.com
- Recruiting
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, 300380
Ruihua Wei, +86 22 8642 8817, ec_tmueh@126.com
About this study
Official title: A Prospective, Multi-center, Open-Label, Randomized Controlled, Non-Inferiority Clinical Study Evaluating the Efficacy and Safety of Contact Lens Lubricant in Rigid Gas Permeable Corneal Contact Lens Wearers
This trial aims to evaluate the safety and effectiveness of LACRIFRESH OCU-DRY 0.3% OSD, a contact lens lubricant produced by AVIZOR, S.A. This clinical trial adopts a Multi-center, randomized, open-label, positive parallel-controlled design in accordance with the principles outlined in the Norms on the Quality Management for the Clinical Trials of Medical Devices issued by the National Medical Products Administration of China.
Meanwhile, following statistical requirements, 152 rigid contact lens wearers are planned to be enrolled after screening and meeting the inclusion criteria. Participants will be randomly assigned to groups and provided with lenses, lubricants, and care solutions accordingly. Clinical follow-up assessments are scheduled at 1 week, 1 month, and 3 months after use.
The primary efficacy indexes are the percentage of patients with binocular comfort score ≥ Level 3 at the 1-month follow-up and the percentage of patients with best corrected distance visual acuity with contact lenses for both eyes ≥5.0 at the 1-month follow-up after using the contact lens lubricant. Secondary efficacy indexes include, best corrected distance visual acuity with lenses, visual acuity with lenses, residual diopter, tear break-up time, uncorrected visual acuity, examination of contact lens fitting status, lens assessment, and contact lens lubricant evaluation during the corresponding follow-up periods. Safety indexes include slit lamp examination, fundus examination, IOP, corneal endothelial cell, adverse events, serious adverse events, device defects that may lead to serious adverse events, other device defects during the corresponding follow-up periods.
- Conditions
- Myopia
- Being tested
- LACRIFRESH OCU-DRY 0.3% OSD, Rigid contact lens lubricant
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LACRIFRESH OCU-DRY 0.3% OSDDevice
Use LACRIFRESH OCU-DRY 0.3% OSD as the daily contact lens lubricant product.
Rigid contact lens lubricantDevice
Use Rigid contact lens lubricant as the daily contact lens lubricant product.
| Study group | Role | What they receive |
|---|---|---|
| Tested medical device | Experimental | LACRIFRESH OCU-DRY 0.3% OSD Receives: Device: LACRIFRESH OCU-DRY 0.3% OSD |
| Control medical device | Active comparator | Rigid contact lens lubricant Receives: Device: Rigid contact lens lubricant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with comfort scores ≥ Level 3 for both eyes at the 1-month follow-up after using the contact lens lubricant.
Measured: 1 month
Percentage of subjects with the best corrected distance visual acuity in both eyes with lenses ≥5.0 at the 1-month follow-up after using the contact lens lubricant.
Measured: 1 month
Secondary outcomes (14)
Changes in subjective symptoms assessed by subjective acceptability Scale of National Medical Products Administration（NMPA）
According to the Guidelines for Registration Review of Contact Lens Care Products of NMPA, subjective acceptability of contact lens care products is investigated through the investigation of subjective symptoms during follow-up, specifically including evaluations of comfort, visual and operability assessments. Higher scores indicate a more favorable outcome for the endpoint. For comfort assessment, the 6-point scale is defined as follows: Level 0: Painful; Level 1: Extremely uncomfortable; Level 2: Mildly uncomfortable; Level 3: Comfortable; Level 4: Very comfortable; Level 5: Excellent. For visual and operability assessments, the 6-point scale is defined as follows: Level 0: Unacceptable; Level 1: Very poor; Level 2: Poor; Level 3: Good; Level 4: Very good; Level 5: Outstanding.
Measured: 1 week, 1 month, and 3 months
Changes in best corrected distance visual acuity with lenses
Measured: 1 week, and 3 months
Changes in lens wearing vision and residual diopter
Measured: 1 week, 1 month, and 3 months
Changes in tear break up time (TBUT)
Measured: 1 week, 1 month, and 3 months
Changes in uncorrected visual acuity
Measured: 1 week, 1 month, and 3 months
Changes in contact lens fitness examination
Measured: 1 week, 1 month, and 3 months
Changes in lens assessment
Measured: 1 week, 1 month, and 3 months
Changes in contact lens lubricant evaluation
Measured: 1 week, 1 month, and 3 months
Changes in slit-lamp examinations
Measured: 1 week, 1 month, and 3 months
Changes in fundus examinations
Measured: 1 month and 3 months
Comparison between groups for intraocular pressure (IOP) at each follow-up visit, along with changes relative to baseline
Measured: 1 week, 1 month, and 3 months
Comparison between groups for examination of corneal endothelial cell at each follow-up visit, along with changes relative to baselineChanges
Measured: 3 months
Incidence of adverse events
Measured: From the date of randomization until the occurrence of adverse events, assessed for up to 3 months
Incidence of serious adverse event
Measured: From the date of randomization until the occurrence of serious adverse event, assessed for up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start27 Jun 2025
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avizor SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091825
- Sponsor's protocol ID
- Avizor-CT
- Status last verified
- Jun 2025
- First submitted
- 26 Jun 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Open-Label, Randomized Controlled, Non-Inferiority Clinical Study Evaluating the Efficacy and Safety of Contact Lens Lubricant in Rigid Gas Permeable Corneal Contact Lens Wearers
- ClinicalTrials.gov ID
- NCT07091825
- Acronym / sponsor ID
- Avizor-CT
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Avizor SAIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 29 Jul 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.
This trial aims to evaluate the safety and effectiveness of LACRIFRESH OCU-DRY 0.3% OSD, a contact lens lubricant produced by AVIZOR, S.A. This clinical trial adopts a Multi-center, randomized, open-label, positive parallel-controlled design in accordance with the principles outlined in the Norms on the Quality Management for the Clinical Trials of Medical Devices issued by the National Medical Products Administration of China.
Meanwhile, following statistical requirements, 152 rigid contact lens wearers are planned to be enrolled after screening and meeting the inclusion criteria. Participants will be randomly assigned to groups and provided with lenses, lubricants, and care solutions accordingly. Clinical follow-up assessments are scheduled at 1 week, 1 month, and 3 months after use.
The primary efficacy indexes are the percentage of patients with binocular comfort score ≥ Level 3 at the 1-month follow-up and the percentage of patients with best corrected distance visual acuity with contact lenses for both eyes ≥5.0 at the 1-month follow-up after using the contact lens lubricant. Secondary efficacy indexes include, best corrected distance visual acuity with lenses, visual acuity with lenses, residual diopter, tear break-up time, uncorrected visual acuity, examination of contact lens fitting status, lens assessment, and contact lens lubricant evaluation during the corresponding follow-up periods. Safety indexes include slit lamp examination, fundus examination, IOP, corneal endothelial cell, adverse events, serious adverse events, device defects that may lead to serious adverse events, other device defects during the corresponding follow-up periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tested medical device | Experimental | Device: LACRIFRESH OCU-DRY 0.3% OSDLACRIFRESH OCU-DRY 0.3% OSD |
| Control medical device | Active comparator | Device: Rigid contact lens lubricantRigid contact lens lubricant |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 8 and older, no gender limitation;
- Rigid gas permeable corneal contact lens (OK lens) wearers;
- The best corrected distance visual acuity of framed lenses in both eyes can reach 5.0 (5-Point Scale);
- Be able and willing to comply with all treatments and follow-ups;
- Be able to understand the purpose of the trial, participate voluntarily and have ICF signed by the subject himself/herself or his/her legal guardian.
Key exclusion criteria (13 listed)
- Patients with only one eye meeting the inclusion criteria.
- Patients with abnormal clinical abnormalities or systemic diseases affecting the eyes that occurred or is occurring before screening and, in the investigator's judgment, preclude the use of corneal contact lenses.
- Patients with some eye diseases that affect contact lens wearing: such as acute or chronic eye diseases, conjunctivitis catarrhalis aestiva, glaucoma, corneal abnormalities, keratoconus, etc.
- Patients with allergies to the components of contact lens or contact lens care solution involved in this trial;
- Patients who are using or need to use drugs that may cause dry eyes or affect vision and corneal curvature (e.g. immunosuppressant, glucocorticoids, IOP-lowering drugs, low concentration atropine) during the study;
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 |
|---|---|---|
| LACRIFRESH OCU-DRY 0.3% OSDUse LACRIFRESH OCU-DRY 0.3% OSD as the daily contact lens lubricant product. | Device | Tested medical device |
| Rigid contact lens lubricantUse Rigid contact lens lubricant as the daily contact lens lubricant product. | Device | Control medical device |
Primary outcome
Percentage of subjects with comfort scores ≥ Level 3 for both eyes at the 1-month follow-up after using the contact lens lubricant.
Time frame: 1 month
Percentage of subjects with the best corrected distance visual acuity in both eyes with lenses ≥5.0 at the 1-month follow-up after using the contact lens lubricant.
Time frame: 1 month
14 secondary outcomes
Changes in subjective symptoms assessed by subjective acceptability Scale of National Medical Products Administration（NMPA）
Time frame: 1 week, 1 month, and 3 months
Changes in best corrected distance visual acuity with lenses
Time frame: 1 week, and 3 months
Changes in lens wearing vision and residual diopter
Time frame: 1 week, 1 month, and 3 months
Changes in tear break up time (TBUT)
Time frame: 1 week, 1 month, and 3 months
Changes in uncorrected visual acuity
Time frame: 1 week, 1 month, and 3 months
Changes in contact lens fitness examination
Time frame: 1 week, 1 month, and 3 months
Changes in lens assessment
Time frame: 1 week, 1 month, and 3 months
Changes in contact lens lubricant evaluation
Time frame: 1 week, 1 month, and 3 months
Changes in slit-lamp examinations
Time frame: 1 week, 1 month, and 3 months
Changes in fundus examinations
Time frame: 1 month and 3 months
Comparison between groups for intraocular pressure (IOP) at each follow-up visit, along with changes relative to baseline
Time frame: 1 week, 1 month, and 3 months
Comparison between groups for examination of corneal endothelial cell at each follow-up visit, along with changes relative to baselineChanges
Time frame: 3 months
Incidence of adverse events
Time frame: From the date of randomization until the occurrence of adverse events, assessed for up to 3 months
Incidence of serious adverse event
Time frame: From the date of randomization until the occurrence of serious adverse event, assessed for up to 3 months
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 29 Jul 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LACRIFRESH OCU-DRY 0.3% OSD and Rigid contact lens lubricant in people with Myopia, run by Avizor SA at 3 sites in China.
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 5 inclusion and 13 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 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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 Yanhong Li (+86(0)1060356258, lyh@cisema.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with comfort scores ≥ Level 3 for both eyes at the 1-month follow-up after using the contact lens lubricant. (time frame: 1 month). The study lists 2 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 29 Jul 2025.