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Dry Eye DiseasePhase 3NCT06942793

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

A Phase 3 study testing CsA-PG Ophthalmic Gel and CsA Ophthalmic Gel in people with Dry Eye Disease, run by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. 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?
CsA-PG Ophthalmic Gel and CsA Ophthalmic Gel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
396 participants
Where
No sites listed yet
Study dates
20 May 2025to 15 Nov 2025
Phase
Phase 3
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
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  • 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
  • Topical ophthalmic autologous serum Exceptions: demulcent ophthalmic drops (e.g., OCCT artificial tears) may be used until Screen Visit 1, but these must be discontinued after screening.
  • Systemic medication (30 days before Visit 1):
  • Any systemic medication known to cause ocular drying (e.g., antidepressants, beta blockers) except if it was taken on a stable dosing regimen for at least 30 days before Visit 1 and is expected to be taken on the same regimen throughout the study period. The known systemic medications that can cause ocular drying include:
  • antihistamines, antidepressants, bronchodilators, antiarrhythmics
  • anti-Parkinson's disease drugs, antipsychotics, antitussives, anticongestants
  • adrenoceptor blockers, thiazide diuretics, anti-leprosy drugs, antimalarials, antineoplastics anxiolytics/sleeping agents, herbs and vitamins, calcium modulators
  • Corticosteroids (e.g., systemic steroids including intravenous, intramuscular, intraarticular, and oral steroids; facial topical steroids; dermatological steroids with high potency or large treatment areas)
  • Cyclosporine and any other immunosuppressor
  • Other medications that can impact dry eye disease favorably or not include various analgesics, including opiates, cannabinoids, omega-3 dietary supplements, and other agents. Such meds should be continued on study only if that represents a continuation of an unavoidable and unchanged regimen of treatment for a disease that is not otherwise excluded
  • Non-medicine treatment (30 days before Visit 1):
  • LipiFlow® or other similar meibomian gland dysfunction (MGD) therapy;
  • Eye mask with heat or steam and any other warming method of the eyelid (e.g., warm towel application);
  • Intense pulsed light treatment;
  • Bandage contact lenses or scleral contact lenses;
  • Route eyelid cleaning;
  • Any other treatment that will relieve dry eye symptoms and signs.
  • Have a severe/serious systemic disease, chronic illness, or uncontrolled medical condition including, but not limited to, severe cardiopulmonary disease, poorly controlled hypertension, poorly controlled diabetes, and/or clinically significant (CS) hematologic, renal, or liver disease that in the opinion of the Investigator could interfere with study assessments or limit compliance;
  • Be a woman who is pregnant, nursing, or planning a pregnancy;
  • Be unwilling to submit a urine pregnancy test at Visit 1 and Visit 5 (or early termination visit) if of childbearing potential. The non-childbearing potential is defined as a woman who is permanently sterilized (e.g., has had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is post-menopausal (i.e., without menses for 12 consecutive months);
  • Be a woman of childbearing potential who is not using an acceptable means of birth control during the study period and 30 days after the end of the study. Acceptable methods of contraception include hormonal (e.g., oral, implantable, injectable, or transdermal contraceptives), mechanical (e.g., spermicide in conjunction with a barrier such as a diaphragm or a condom), intrauterine device (IUD), or surgical sterilization of partner. For non-sexually active females, abstinence might be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the study, she must agree to use acceptable birth control as defined above for the remainder of the study;
  • Have a known hypersensitivity or contraindication to the investigational products (IPs) or their components;
  • Have a condition or be in a situation that the Investigator felt may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study (e.g., any planned procedure or surgery during the study period);
  • Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days before Visit 1;
  • In the opinion of the Investigator, be unable or unwilling to comply with the study protocol, including participation in all study assessments, visits, and dosing, or be unable to instill eye drops successfully.

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-Masked, Active-Controlled Study to Evaluate the Efficacy and Safety of Treatment With CsA-PG Ophthalmic Gel in Dry Eye Patients

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.

Read the detailed description

396 subjects will be enrolled (198 in each treatment group). Subject selection will be conducted during a 14-day run-in period before randomization. After the screening, subjects will receive lubricant eye drops (Refresh Tears®, Carboxymethylcellulose Sodium (0.5%)) treatment bilaterally BID for 14 days. Eligible subjects will be randomized (1:1) and receive the experimental drug or control drug , administered bilaterally once daily for 84 days.

Conditions
Dry Eye Disease
Being tested
CsA-PG Ophthalmic Gel, CsA Ophthalmic Gel
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.

  • CsA-PG Ophthalmic GelDrug

    Administer to eyes

  • CsA Ophthalmic GelDrug

    Administer to eyes

Study groups in NCT06942793
Study groupRoleWhat they receive
Experimental groupExperimental1 drop each time, bilaterally once daily
Receives: Drug: CsA-PG Ophthalmic Gel
Control groupPlacebo comparator1 drop each time, bilaterally once daily
Receives: Drug: CsA Ophthalmic Gel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 84 days

Secondary outcomes (2)

  1. Total Corneal Staining Score(TCSS)

    The proportion of patients achieving complete resolution of total corneal staining (TCSS= 0 ) at Day 84.TCSS is scored on a 0-to-20-point scale, higher numerical values correlate with increased severity of corneal damage.

    Measured: 84 days

  2. Schirmer Tear Test (STT)

    At day 84, the proportion of patients improved by ≥ 10 mm from baseline.

    Measured: 84 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2025
  2. Study start20 May 2025 (estimated)
  3. Primary completion20 Oct 2025 (estimated)
  4. Study completion15 Nov 2025 (estimated)

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
396 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06942793
Sponsor's protocol ID
ZKY-CSA-202401
Status last verified
Apr 2025
First submitted
16 Apr 2025
Last updated
29 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CsA-PG Ophthalmic Gel and CsA Ophthalmic Gel in people with Dry Eye Disease, run by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd..

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 7 inclusion and 39 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: opening soon, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

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?

Eye Dryness Score(EDS) (time frame: 84 days). 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 NCT06942793.

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 Apr 2025.

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