Treatment of Dry Eye Disease With Meibomian Gland DysfunctionPhase 3NCT05515471
Effect of SHR8058 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction
A Phase 3 study testing SHR8058 eye drops and saline eye drops. in people with Treatment of Dry Eye Disease With Meibomian Gland Dysfunction, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy and safety of SHR8058 eye drops for patients with dry eye disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment of Dry Eye Disease With Meibomian Gland Dysfunction
- What is being tested?
- SHR8058 eye drops and saline eye drops.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 312 participants
- Where
- 1 siteChina
- Study dates
- 4 Feb 2021to 7 Sep 2021
- 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
- Signed ICF (Informed Consent Form)
- Subject-reported history of Drye Eye Disease (DED) in both eyes
- Ability and willingness to follow instructions, including participation in all study assessments and visits
Who cannot join
- clinically significant slit lamp findings or abnormal lid anatomy at screening, including eye trauma, pterygium, active blepharitis, and active lid margin inflammation;
- Stevens-Johnson syndrome or other severe systemic autoimmune diseases;
- underwent LipiFlow procedure or intention pulsed light therapy within 6 months before baseline, or received Meibomian gland massage treatment within 2 weeks before baseline;
- received or removed permanent lacrimal plug within 3 months before baseline;
- DED secondary to scarring, radiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells;
- ocular or periocular malignancy;
Show all 15Show fewer
- active ocular allergies, or allergy to the study drug or its components;
- ongoing ocular or systemic infection;
- use of contact lenses within 1 month before screening;
- intraocular surgery or ocular laser surgery within 6 months before enrollment;
- uncontrolled systemic disease or history of herpetic keratitis;
- use of topical steroids, topical cyclosporine, lifitegrast, serum tears, or topical anti-glaucoma medication within 60 days before screening;
- used any known oral drugs that could have caused eye dryness within 1 month before screening;
- participated in or were participating in other clinical trials drugs or device within 60 days before baseline;
- inappropriate to participate for other reasons judged by the investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3, Multi-Center, Randomized, Double-Masked, Saline-Controlled Trial to Evaluate the Effect of SHR8058 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction
The study is being conducted to evaluate the efficacy and safety of SHR8058 eye drops for patients with dry eye disease.
- Being tested
- SHR8058 eye drops, saline eye drops.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR8058 eye dropsDrug
SHR8058 eye drops
saline eye drops.Drug
saline eye drops.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: SHR8058 eye drops | Experimental | Not described Receives: Drug: SHR8058 eye drops |
| Treatment group B: saline eye drops | Placebo comparator | Not described Receives: Drug: saline eye drops. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in total Corneal Fluorescein Staining (NEI scale) at Day 57
The National Eye Institute (NEI) scale relies on a chart that divides the cornea into five sections (central, superior, temporal, nasal, and inferior) and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the punctate keratitis, for a maximum total score of 15 points (sum of scores for each section).
Measured: Baseline, Day 57
Change from baseline in Dryness Score (visual analogue scale [VAS] Severity of Dryness) at Day 57
Study staff will ask participants to rate their severity of ocular dryness (both eyes simultaneously) by placing a vertical mark on a horizontal line to indicate the level of discomfort (0 corresponds to "no dryness" and 100% corresponds to "maximal dryness").
Measured: Baseline, Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start4 Feb 2021
- Primary completion7 Sep 2021
- Study completion7 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Treatment of Dry Eye Disease With Meibomian Gland DysfunctionStudies 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
- Model description
- SHR8058 eye drops compared with placebo
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 312 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
- NCT05515471
- Sponsor's protocol ID
- SHR8058-301
- Status last verified
- Aug 2022
- First submitted
- 23 Aug 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhu Y, Xie J, Shi X, Sun Y. Perfluorohexyloctane Eye Drops in Premenopausal and Postmenopausal Women with Dry Eye Disease Associated with Meibomian Gland Dysfunction: A Post Hoc Analysis of a Phase 3 Trial. Curr Eye Res. 2026 Jan;51(1):9-15. doi: 10.1080/02713683.2025.2549289. Epub 2025 Sep 2.
PubMed 40898391Tian L, Gao Z, Zhu L, Shi X, Zhao S, Gu H, Xu G, Wang L, Dai H, Zhang H, Jin X, Ma K, Xu Y, Ma L, Pei C, Ke B, Krosser S, Zhang Y, Jie Y. Perfluorohexyloctane Eye Drops for Dry Eye Disease Associated With Meibomian Gland Dysfunction in Chinese Patients: A Randomized Clinical Trial. JAMA Ophthalmol. 2023 Apr 1;141(4):385-392. doi: 10.1001/jamaophthalmol.2023.0270.
PubMed 36929413
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multi-Center, Randomized, Double-Masked, Saline-Controlled Trial to Evaluate the Effect of SHR8058 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT05515471
- Acronym / sponsor ID
- SHR8058-301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 7 Sep 2021 (actual)
- Study completion
- 7 Sep 2021 (actual)
- First posted
- 25 Aug 2022 (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 evaluate the efficacy and safety of SHR8058 eye drops for patients with 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
- Model description
- SHR8058 eye drops compared with placebo
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: SHR8058 eye drops | Experimental | Drug: SHR8058 eye drops |
| Treatment group B: saline eye drops | Placebo comparator | Drug: saline eye drops. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed ICF (Informed Consent Form)
- Subject-reported history of Drye Eye Disease (DED) in both eyes
- Ability and willingness to follow instructions, including participation in all study assessments and visits
Key exclusion criteria (15 listed)
- clinically significant slit lamp findings or abnormal lid anatomy at screening, including eye trauma, pterygium, active blepharitis, and active lid margin inflammation;
- Stevens-Johnson syndrome or other severe systemic autoimmune diseases;
- underwent LipiFlow procedure or intention pulsed light therapy within 6 months before baseline, or received Meibomian gland massage treatment within 2 weeks before baseline;
- received or removed permanent lacrimal plug within 3 months before baseline;
- DED secondary to scarring, radiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells;
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 |
|---|---|---|
| SHR8058 eye dropsSHR8058 eye drops | Drug | Treatment group A: SHR8058 eye drops |
| saline eye drops.saline eye drops. | Drug | Treatment group B: saline eye drops |
Primary outcome
Change from baseline in total Corneal Fluorescein Staining (NEI scale) at Day 57
Time frame: Baseline, Day 57
The National Eye Institute (NEI) scale relies on a chart that divides the cornea into five sections (central, superior, temporal, nasal, and inferior) and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the punctate keratitis, for a maximum total score of 15 points (sum of scores for each section).
Change from baseline in Dryness Score (visual analogue scale [VAS] Severity of Dryness) at Day 57
Time frame: Baseline, Day 57
Study staff will ask participants to rate their severity of ocular dryness (both eyes simultaneously) by placing a vertical mark on a horizontal line to indicate the level of discomfort (0 corresponds to "no dryness" and 100% corresponds to "maximal dryness").
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 25 Aug 2022.
- Derived from this study: PubMed 40898391Zhu Y, Xie J, Shi X, Sun Y. Perfluorohexyloctane Eye Drops in Premenopausal and Postmenopausal Women with Dry Eye Disease Associated with Meibomian Gland Dysfunction: A Post Hoc Analysis of a Phase 3 Trial. Curr Eye Res. 2026 Jan;51(1):9-15. doi: 10.1080/02713683.2025.2549289. Epub 2025 Sep 2.
- Derived from this study: PubMed 36929413Tian L, Gao Z, Zhu L, Shi X, Zhao S, Gu H, Xu G, Wang L, Dai H, Zhang H, Jin X, Ma K, Xu Y, Ma L, Pei C, Ke B, Krosser S, Zhang Y, Jie Y. Perfluorohexyloctane Eye Drops for Dry Eye Disease Associated With Meibomian Gland Dysfunction in Chinese Patients: A Randomized Clinical Trial. JAMA Ophthalmol. 2023 Apr 1;141(4):385-392. doi: 10.1001/jamaophthalmol.2023.0270.
- 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 SHR8058 eye drops and saline eye drops. in people with Treatment of Dry Eye Disease With Meibomian Gland Dysfunction, 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 3 inclusion and 15 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 25 Aug 2022. 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 from baseline in total Corneal Fluorescein Staining (NEI scale) at Day 57 (time frame: Baseline, Day 57). 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 NCT05515471, which also lists 2 linked publications.
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 25 Aug 2022.