---
title: Efficacy and Safety of SHR8028 Eye Drops for the Treatment of Dry Eye Disease
nct_id: NCT05841043
overall_status: COMPLETED
phase: PHASE3
sponsor: Jiangsu HengRui Medicine Co., Ltd.
study_type: INTERVENTIONAL
primary_condition: Dry Eye Disease
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05841043.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05841043"
ct_last_update_post_date: 2023-05-03
last_seen_at: "2026-05-12T06:46:32.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy and Safety of SHR8028 Eye Drops for the Treatment of Dry Eye Disease

**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

**NCT ID:** [NCT05841043](https://clinicaltrials.gov/study/NCT05841043)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 206
- **Lead Sponsor:** Jiangsu HengRui Medicine Co., Ltd.
- **Conditions:** Dry Eye Disease
- **Start Date:** 2021-03-04
- **Completion Date:** 2022-07-22
- **CT.gov Last Update:** 2023-05-03

## Brief 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. Age ≥ 18 years old;
2. Provide written informed consent form;
3. Have a subject reported history of dry eye disease in both eyes for at least 180 days before the screening visit (visit 0);
4. 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;
5. Have at least one eye meets criteria of moderate to severe dry eye both at visit 0\&1
6. Be able and willing to follow instructions and participate in all study assessments and visits.

Exclusion Criteria:

1. 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;
2. 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);
3. Have active ocular allergy or ocular allergy that may occur during the study;
4. 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;
5. Be a woman who is pregnant, breastfeeding, or planning pregnancy;
6. Have an uncontrolled systemic disease;
7. Have allergies to investigational medicinal product (IMP) or its components: cyclosporin A or semi-fluorinated alkanes (SFA);
8. Be currently participating in other drug or device trials, or have used other investigational drugs or devices within 60 days before visit 0;
9. 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;
10. 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.
```

## Arms

- **SHR8028 eye drops** (EXPERIMENTAL)
- **Vehicle** (PLACEBO_COMPARATOR)

## Interventions

- **SHR8028 eye drops** (DRUG) — SHR8028 eye drops
- **Vehicle eye drops.** (DRUG) — Vehicle eye drops.

## Primary Outcomes

- **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)_

## Locations (1)

- Peking University Third Hospital, Beijing, Beijing Municipality, China

## Recent Field Changes (last 30 days)

- `locations.peking university third hospital|beijing|beijing municipality|china` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT05841043*  
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