A Study to Evaluate the Efficacy and Safety of Treatment With CsA-PG Ophthalmic Gel in Dry Eye Patients

NCT06942793 | Not Yet Recruiting Phase 3

• 1 other identifier: ZKY-CSA-202401
• Study Type: interventional
• Target: 396
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a phase III, multicenter, randomized, double-masked, Active-controlled design. The aims to confirm previous findings of the efficacy and safety of CsA-PG Ophthalmic Gel by comparing it to CsA Ophthalmic Gel for treating dry eye symptoms.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• Eye Dryness Score(EDS)

  The mean change from baseline in EDS (Eye Dryness Score) at the 84 days , with EDS assessment performed using a Visual Analogue Scale (VAS). The VAS score employs a 0 to 100-point scale (0 = no symptoms; 100 = extreme severity/intolerable discomfort), where higher scores indicate greater symptom severity.

  84 days

Secondary Outcomes (2)

• Total Corneal Staining Score(TCSS)

  84 days

• Schirmer Tear Test (STT)

  84 days

Study Arms (2)

Experimental group

EXPERIMENTAL

1 drop each time, bilaterally once daily

Drug: CsA-PG Ophthalmic Gel

Control group

PLACEBO COMPARATOR

1 drop each time, bilaterally once daily

Drug: CsA Ophthalmic Gel

Interventions

CsA-PG Ophthalmic Gel DRUG

Administer to eyes

Experimental group

CsA Ophthalmic Gel DRUG

Administer to eyes

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 18 years of age, male or female;
• Provide written informed consent;
• Have a reported history of dry eye for at least 6 months before Visit 1;
• Have a clinical diagnosis of bilateral dry eye disease, including all of the following scored in at least one eye at both Visits 1 and 2;
• Corneal fluorescein staining score in either inferior, superior, or central zone ≥ 2
• Schirmer Tear Test score (STT, anesthetized) of ≤ 10 mm and ≥ 1 mm
• Have an Eye Dryness Score (EDS; Visual Analogue scale, VAS) ≤80 and ≥40

You may not qualify if:

• Clinical diagnosis or history of any clinically significant ocular diseases/disorders (e.g., age-related maculopathy that requires treatment and/or in the opinion of the Investigator may interfere with study parameters in Visit 1 and/or Visit 2;
• Any active ocular or systemic infection (e.g., bacterial, viral, or fungal) at Visit 1 and/or Visit 2;
• Any active ocular inflammation (e.g., iritis, uveitis, allergic conjunctivitis) at Visit 1 and/or Visit 2;
• Any conjunctival scarring history (Such as with irradiation, alkali burns, Steven Johnson syndrome, Sjogren's syndrome, cicatricial pemphigoid) or destruction of conjunctival goblet cells (e.g., neurotrophic keratitis, vitamin A deficiency) before Visit 1;
• Have worn contact lenses within 14 days of Visit 1 or anticipate using contact lenses during the study;
• Have any refractive surgery and/or any other ocular surgical procedure within 3 months before Visit 1; or have any ocular surgical procedure scheduled to be conducted during the study period;
• Have eyelid surgery within 6 months before Visit 1 or planned eyelid surgery during the study period;
• Have Nd:YAG (neodymium-doped yttrium aluminum garnet) laser capsulotomy within 6 months before Visit 1;
• Have used temporary (i.e., collagen) punctual plugs within 3 months before Visit 1 or anticipate their use during the study period;
• Have permanent punctual plugs inserted or have surgical punctual occlusion before Visit 1 or anticipate any such event during the study period;
• Use any of the following treatments in the period indicated before Visit 1 or anticipate their use at any time during the study.
• Topical medications（30 days prior to Visit 1）:
• Restasis®, Cequa™, Tyrvaya, Eysuvis, Xiidra
• Topical ophthalmic non-steroidal anti-inflammatories
• Topical ophthalmic corticosteroids

Sponsors & Collaborators

• Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 24, 2025
• Study Start: May 20, 2025
• Primary Completion: October 20, 2025
• Study Completion: November 15, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-04