Dry Eye DiseasePhase 3NCT05841043
Efficacy and Safety of SHR8028 Eye Drops for the Treatment of Dry Eye Disease
A Phase 3 study testing SHR8028 eye drops in people with Dry Eye Disease, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to assess the efficacy, safety and tolerability of SHR8028 eye drops in comparison to the vehicle for the treatment of dry eye disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- SHR8028 eye drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2021to 22 Jul 2022
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old;
- Provide written informed consent form;
- Have a subject reported history of dry eye disease in both eyes for at least 180 days before the screening visit (visit 0);
- Be currently (within 30 days before visit 0) using over-the-counter (OTC) eye drops, lubricating gels or tear neurostimulator device (such as True TearTM), and/or artificial tears for dry eye symptoms;
- Have at least one eye meets criteria of moderate to severe dry eye both at visit 0\&1
- Be able and willing to follow instructions and participate in all study assessments and visits.
Who cannot join
- Have any clinically significant slit-lamp findings at visit 0 that require treatment with prescription drugs and/or in the opinion of the investigator may interfere with study parameters, such as trauma, Stevens-Johnson syndrome, or advanced epithelial basement membrane disease;
- Have dry eye disease secondary to scar formation, such as radiation, alkali burn, cicatricial pemphigus, and destruction of conjunctival goblet cells (i.e., destruction of conjunctival goblet cells caused by vitamin A deficiency);
- Have active ocular allergy or ocular allergy that may occur during the study;
- Be diagnosed with an ongoing ocular or systemic infection (bacterial, viral, or fungal), including fever, or be undergoing treatment with antibiotics at visit 0 and visit 1;
- Be a woman who is pregnant, breastfeeding, or planning pregnancy;
- Have an uncontrolled systemic disease;
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- Have allergies to investigational medicinal product (IMP) or its components: cyclosporin A or semi-fluorinated alkanes (SFA);
- Be currently participating in other drug or device trials, or have used other investigational drugs or devices within 60 days before visit 0;
- Have a condition which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere with the subject's participation in the study significantly;
- Have received or removed lacrimal duct embolism within 90 days before visit 0, or plan to receive or remove lacrimal duct embolism during the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: A Multi-Center, Randomized, Double-masked, Vehicle-Controlled Phase III Clinical Study to Assess the Efficacy and Safety of SHR8028 Eye Drops for the Treatment of Dry Eye Disease
The study is being conducted to assess the efficacy, safety and tolerability of SHR8028 eye drops in comparison to the vehicle for the treatment of dry eye disease.
- Conditions
- Dry Eye Disease
- Being tested
- SHR8028 eye drops, Vehicle eye drops.
- 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.
SHR8028 eye dropsDrug
SHR8028 eye drops
Vehicle eye drops.Drug
Vehicle eye drops.
| Study group | Role | What they receive |
|---|---|---|
| SHR8028 eye drops | Experimental | Not described Receives: Drug: SHR8028 eye drops |
| Vehicle | Placebo comparator | Not described Receives: Drug: Vehicle eye drops. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total corneal fluorescein staining (tCFS) score (National Eye Institute [NEI] scale) from baseline on Day 29
Measured: Baseline, Day 29
Change in eye dryness score (visual analogue scale [VAS] Severity of Dryness) from baseline on Day 29
Measured: Baseline, Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start4 Mar 2021
- Primary completion2 Apr 2022
- Study completion22 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841043
- Sponsor's protocol ID
- SHR8028-301
- Status last verified
- Apr 2023
- First submitted
- 24 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Peng R, Jie Y, Long Q, Gong L, Zhu L, Zhong X, Zhao S, Yan X, Gu H, Wu H, Li G, Zhang K, Krosser S, Xu R, Hong J. Water-Free Cyclosporine Ophthalmic Solution vs Vehicle for Dry Eye Disease: A Randomized Clinical Trial. JAMA Ophthalmol. 2024 Apr 1;142(4):337-343. doi: 10.1001/jamaophthalmol.2024.0101.
PubMed 38451509
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-masked, Vehicle-Controlled Phase III Clinical Study to Assess the Efficacy and Safety of SHR8028 Eye Drops for the Treatment of Dry Eye Disease
- ClinicalTrials.gov ID
- NCT05841043
- Acronym / sponsor ID
- SHR8028-301
- Conditions
- Dry Eye Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 2 Apr 2022 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 3 May 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.
The study is being conducted to assess the efficacy, safety and tolerability of SHR8028 eye drops in comparison to the vehicle for the treatment of dry eye disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR8028 eye drops | Experimental | Drug: SHR8028 eye drops |
| Vehicle | Placebo comparator | Drug: Vehicle eye drops. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years old;
- Provide written informed consent form;
- Have a subject reported history of dry eye disease in both eyes for at least 180 days before the screening visit (visit 0);
- Be currently (within 30 days before visit 0) using over-the-counter (OTC) eye drops, lubricating gels or tear neurostimulator device (such as True TearTM), and/or artificial tears for dry eye symptoms;
- Have at least one eye meets criteria of moderate to severe dry eye both at visit 0\&1
Key exclusion criteria (10 listed)
- Have any clinically significant slit-lamp findings at visit 0 that require treatment with prescription drugs and/or in the opinion of the investigator may interfere with study parameters, such as trauma, Stevens-Johnson syndrome, or advanced epithelial basement membrane disease;
- Have dry eye disease secondary to scar formation, such as radiation, alkali burn, cicatricial pemphigus, and destruction of conjunctival goblet cells (i.e., destruction of conjunctival goblet cells caused by vitamin A deficiency);
- Have active ocular allergy or ocular allergy that may occur during the study;
- Be diagnosed with an ongoing ocular or systemic infection (bacterial, viral, or fungal), including fever, or be undergoing treatment with antibiotics at visit 0 and visit 1;
- Be a woman who is pregnant, breastfeeding, or planning pregnancy;
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 |
|---|---|---|
| SHR8028 eye dropsSHR8028 eye drops | Drug | SHR8028 eye drops |
| Vehicle eye drops.Vehicle eye drops. | Drug | Vehicle |
Primary outcome
Change in total corneal fluorescein staining (tCFS) score (National Eye Institute [NEI] scale) from baseline on Day 29
Time frame: Baseline, Day 29
Change in eye dryness score (visual analogue scale [VAS] Severity of Dryness) from baseline on Day 29
Time frame: Baseline, Day 29
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 3 May 2023.
- Derived from this study: PubMed 38451509Peng R, Jie Y, Long Q, Gong L, Zhu L, Zhong X, Zhao S, Yan X, Gu H, Wu H, Li G, Zhang K, Krosser S, Xu R, Hong J. Water-Free Cyclosporine Ophthalmic Solution vs Vehicle for Dry Eye Disease: A Randomized Clinical Trial. JAMA Ophthalmol. 2024 Apr 1;142(4):337-343. doi: 10.1001/jamaophthalmol.2024.0101.
- Individual participant dataSharing planned: Undecided
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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 Phase 3 study testing SHR8028 eye drops in people with Dry Eye Disease, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site 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 6 inclusion and 10 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 3 May 2023. 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 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in total corneal fluorescein staining (tCFS) score (National Eye Institute [NEI] scale) from baseline on Day 29 (time frame: Baseline, Day 29). 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?
On the ClinicalTrials.gov record for NCT05841043, which also lists 1 linked publication.
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 3 May 2023.