Age Related CataractsPhase 2NCT07395986
A Multicenter, Randomized, Double-Masked, Placebo-Controlled Pilot Study to Evaluate the Efficacy and Safety of ZOC2017217 in Subjects With Age-Related Cataract
A Phase 2 study testing 0.4% ZOC2017217 in people with Age Related Cataracts, run by Ocusun Ophthalmic Pharmaceutical (Guangzhou) Co., Ltd. at 21 sites in United States.
Trial summary
This is a multicenter, randomized, double-masked, placebo-controlled pilot study conducted in the United States (US) in subjects with age-related cataract in one or both eyes. Approximately 40 subjects with age-related cataract will be stratified by race and Best Corrected Distance Visual Acuity (BCDVA) and randomized… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age Related Cataracts
- What is being tested?
- 0.4% ZOC2017217
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 21 sitesUnited States
- Study dates
- 10 Feb 2026to Feb 2027
- Phase
- Phase 2
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are ≥50 years of age.
- Willing and able to provide informed consent and provide relevant privacy authorization(s).
- Willing and able to comply with study requirements and visit schedule.
- Able to successfully administer ophthalmic solution or have an appropriate designee (e.g., family member, health care professional) who can administer ophthalmic solution.
- Have high-contrast BCDVA under photopic conditions ≥35 letters and ≤67 letters at Visit 1 (Screening).
- Have calculated baseline BCDVA at Visit 2 (Randomization; Baseline; Day 1) that simultaneously meets Randomization Criteria.
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- Have, in the opinion of the Investigator, age-related cataract (cortical, nuclear, posterior, mixed) in one or both eyes, as assessed using digital imaging after adequate mydriasis.
- C < 5.0 B. N < 5.0 (both nuclear opalescence [NO] and nuclear color [NC]) C. P < 1.0
- Have, in the opinion of the Investigator, sufficiently clear ocular media and adequate pupillary dilation to permit quality fundus imaging.
Who cannot join
- Ocular Exclusion Criteria:
- Study Eye:
- Have a history of ocular trauma.
- Have a history of intraocular surgery, laser treatment, or corneal surgery. Note: Corneal refractive surgery more than 2 years prior to Visit 1 (Screening) is allowed.
- Have, in the opinion of the Investigator, a cataract other than age-related cataract (e.g., traumatic, concurrent, metabolic, drug and toxic, radiation).
- Have, in the opinion of the Investigator, any ocular disease or condition that is not stably controlled or is likely to affect central vision, including but not limited to:
Show all 30Show fewer
- Glaucoma Elevated IOP (e.g., ≥30 mmHg) Optic neuropathy Age-related macular degeneration Diabetic retinopathy Retinal artery or vein occlusion Macular hole Retinal detachment Epiretinal membrane involving the fovea High myopia (i.e., spherical equivalent of subjective refraction ≥ -7.0 D) High hyperopia (i.e., spherical equivalent of subjective refraction > +4.00 D)
- Have overall CFS >3.
- Have active eye infection or inflammation, including but not limited to conjunctivitis, keratitis, scleritis, or endophthalmitis.
- Note: Mild inflammation (CFS <3 on the NEI scale) from ocular surface disease, including dry eye disease, is allowed.
- Non-study Eye:
- Have high-contrast BCDVA under photopic conditions ≤19 letters.
- Either Eye:
- Have planned or be planning to undergo cataract surgery during the study. Note: A history of cataract surgery in the non-study eye is allowed for subjects who commit to not undergoing additional cataract surgery during the study.
- Have newly developed or not stably controlled uveitis within the 6 months prior to Visit 1 (Screening).
- Unwilling or unable to discontinue wearing contact lenses 14 days prior to Visit 2 (Randomization; Baseline; Day 1), and during the study conduct.
- Requires, is likely to require, or is unwilling to discontinue the use of prohibited medications or procedures within 14 days prior to Visit 1 (Screening), or during the study conduct.
- Other ocular surgeries that may affect visual function, including but not limited to photodynamic therapy. B. Desferrioxamine, hydroxychloroquine, chloroquine, tamoxifen, phenothiazines, ethambutol, or other agents known to cause crystalline lens, retinal, or optic nerve toxicity.
- Chlorpromazine or corticosteroids that may aggravate crystalline lens opacity.
- Note: Topical non-ocular corticosteroids are allowed.
- General Exclusion Criteria:
- Have a severe or not stably controlled systemic disease that may interfere with study participation or confound interpretability (e.g., acute phase of chronic obstructive pulmonary disease; congestive heart failure; severe hepatic or renal insufficiency; malignant tumors currently being treated with chemotherapy).
- Have diabetes mellitus with HbA1c ≥7.5%.
- Have hypertension that is not stably controlled at Visit 1 (Screening) A. Systolic blood pressure: >180 mmHg B. Diastolic blood pressure: >100 mmHg after standard of care
- Have participated or are planning to participate in a clinical study for an investigational drug/medical device within 30 days prior to Visit 1 (Screening), or during the study conduct.
- Are pregnant, nursing, or planning a pregnancy during the study.
- Unwilling or unable to use an acceptable method of contraception throughout the study if a woman of childbearing potential (WOCBP).
- Unwilling or unable to use an acceptable method of contraception throughout the study if a male sexual partner of a WOCBP.
- Have a family member or household member enrolled in the study.
- Have any condition, in the opinion of the Investigator, that makes the subject unsuitable for study participation.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Cincinnati Eye Institute - Blue Ash
Blue Ash, Ohio, 45242
Oculus Research - Cary
Cary, North Carolina, 27518
Rand Eye Institute
Deerfield Beach, Florida, 33064
Erie Retina Research
Erie, Pennsylvania, 16505
Verum Research
Eugene, Oregon, 97401
Bergstrom Eye Research
Fargo, North Dakota, 58103
Global Research Management
Glendale, California, 91204
ICON Eye Care
Grand Junction, Colorado, 81501
Inland Eye Specialists
Hemet, California, 92545
United Medical Research Institute
Inglewood, California, 90301
Levenson Eye Associates
Jacksonville, Florida, 32204
Valley Retina Institute P.A.
Laredo, Texas, 78041
Advanced Vision Research Institute
Longmont, Colorado, 80503
Valley Retina Institute P.A.
McAllen, Texas, 78503
Clayton Eye Clinical Research, LLC
Morrow, Georgia, 30260
North Bay Eye Associates, Inc.
Petaluma, California, 94954
R and R Eye Research, LLC
San Antonio, Texas, 78229
Cornea and Cataract Consultants of Arizona
Scottsdale, Arizona, 85255
Springfield Clinic
Springfield, Illinois, 62703
East West Eye Institute - Torrance
Torrance, California, 90505
Catalina Eye
Tucson, Arizona, 85712
About this study
This is a multicenter, randomized, double-masked, placebo-controlled pilot study conducted in the United States (US) in subjects with age-related cataract in one or both eyes.
Approximately 40 subjects with age-related cataract will be stratified by race and Best Corrected Distance Visual Acuity (BCDVA) and randomized (1:1) to active investigational product (IP) or placebo. Subjects will administer their assigned IP in both eyes, except as noted below, two times a day (BID) for 24 weeks before being exited from the study. Subjects with new or ongoing ocular adverse events (AEs) at the time of planned study exit will be asked to return 2 weeks later for a safety follow-up evaluation.
The study eye will be the qualified eye that meets study eligibility criteria. Data from the study eye will be used for the purposes of efficacy analyses. Both eyes will receive treatment, except in subjects who have previously undergone cataract surgery in the non-study eye or whose non-study eye, in the opinion of the Investigator, is not suitable for treatment with the IP due to safety or another concern.
- Conditions
- Age Related Cataracts
- Being tested
- 0.4% ZOC2017217, Control
- Keywords
- Cataract, Cataracts, Age related cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.4% ZOC2017217Drug
Active Investigational Product
ControlDrug
Control
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Drug with no active ingredients Receives: Drug: Control |
| Active | Experimental | ZOC2017217 Receives: Drug: 0.4% ZOC2017217 |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCDVA
Change from baseline in BCDVA at Weeks 4, 12, and 24.
Measured: Baseline as compared to Weeks 4, 12, and 24.
Contrast Sensitivity
Change from baseline in contrast sensitivity at Weeks 4, 12, and 24.
Measured: Baseline as compared to Weeks 4, 12, and 24.
Visual Function Questionnaire (VFQ-25)
Change from baseline in Visual Function Questionnaire (VFQ-25) scores at Weeks 4, 12, and 24. VFQ-25 score total should increase from the baseline visit to show better visual function at Weeks 4, 12, and 24.
Measured: Baseline compared to Weeks 4, 12, and 24.
Crystalline Lens Opacity
Change from baseline in crystalline lens opacity at Weeks 4, 12, and 24.
Measured: Baseline compared to Weeks 4, 12, and 24.
BCDVA
Proportion of subjects gaining ≥5, ≥10, or ≥15 letters from baseline in BCDVA at Weeks 4, 12, and 24.
Measured: Baseline compared to Weeks 4, 12, and 24.
BCDVA
Proportion of subjects losing ≤5, ≤10, or ≤15 letters from baseline in BCDVA at Weeks 4, 12, and 24.
Measured: Baseline compared to Weeks 4, 12, and 24.
BCDVA
Proportion of subjects achieving BCDVA ≥0.3, 0.1, or 0.0 Logarithm of the Minimum Angle of Resolution (LogMAR; Snellen: 20/40, 20/25, or 20/20) at Weeks 4, 12, and 24.
Measured: Baseline compared to Weeks 4, 12, and 24.
Secondary outcomes (2)
Safety, AEs
AE monitoring (ocular and non-ocular)
Measured: From the start of use of the IP at Visit 2 (Day 1) to the time the subject is exited after Visit 6 procedures and assessments are conducted. Visit 6 is conducted 2 weeks after the last dose is given at Week 24.
Safety, Clinically Relevant Changes
Clinically relevant changes from baseline in the following:
Vital signs Slit-lamp biomicroscopy Corneal fluorescein staining (CFS)-National Eye Institute (NEI) Grading Scale Corneal endothelial cell count Intraocular pressure (IOP) Dilated fundus examination
Measured: From the start of use of the IP at Visit 2 (Day 1) to the time the subject is exited after Visit 6 procedures and assessments are conducted. Visit 6 is conducted 2 weeks after the last dose is given at Week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start10 Feb 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related CataractsStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ocusun Ophthalmic Pharmaceutical (Guangzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395986
- Sponsor's protocol ID
- GOCS-H101-E06
- Status last verified
- Aug 2026
- First submitted
- 15 Jan 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Masked, Placebo-Controlled Pilot Study to Evaluate the Efficacy and Safety of ZOC2017217 in Subjects With Age-Related Cataract
- ClinicalTrials.gov ID
- NCT07395986
- Acronym / sponsor ID
- GOCS-H101-E06
- Conditions
- Age Related Cataracts
- Keywords
- Cataract, Cataracts, Age related cataract
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Ocusun Ophthalmic Pharmaceutical (Guangzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 9 Feb 2026 (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.
This is a multicenter, randomized, double-masked, placebo-controlled pilot study conducted in the United States (US) in subjects with age-related cataract in one or both eyes.
Approximately 40 subjects with age-related cataract will be stratified by race and Best Corrected Distance Visual Acuity (BCDVA) and randomized (1:1) to active investigational product (IP) or placebo. Subjects will administer their assigned IP in both eyes, except as noted below, two times a day (BID) for 24 weeks before being exited from the study. Subjects with new or ongoing ocular adverse events (AEs) at the time of planned study exit will be asked to return 2 weeks later for a safety follow-up evaluation.
The study eye will be the qualified eye that meets study eligibility criteria. Data from the study eye will be used for the purposes of efficacy analyses. Both eyes will receive treatment, except in subjects who have previously undergone cataract surgery in the non-study eye or whose non-study eye, in the opinion of the Investigator, is not suitable for treatment with the IP due to safety or another concern.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: ControlDrug with no active ingredients |
| Active | Experimental | Drug: 0.4% ZOC2017217ZOC2017217 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
Key exclusion criteria (30 listed)
- Ocular Exclusion Criteria:
- Have a history of ocular trauma.
- Have a history of intraocular surgery, laser treatment, or corneal surgery. Note: Corneal refractive surgery more than 2 years prior to Visit 1 (Screening) is allowed.
- Have, in the opinion of the Investigator, a cataract other than age-related cataract (e.g., traumatic, concurrent, metabolic, drug and toxic, radiation).
- Have, in the opinion of the Investigator, any ocular disease or condition that is not stably controlled or is likely to affect central vision, including but not limited to:
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 |
|---|---|---|
| 0.4% ZOC2017217Active Investigational Product | Drug | Active |
| ControlControl | Drug | Control |
Primary outcome
BCDVA
Time frame: Baseline as compared to Weeks 4, 12, and 24.
Change from baseline in BCDVA at Weeks 4, 12, and 24.
Contrast Sensitivity
Time frame: Baseline as compared to Weeks 4, 12, and 24.
Change from baseline in contrast sensitivity at Weeks 4, 12, and 24.
Visual Function Questionnaire (VFQ-25)
Time frame: Baseline compared to Weeks 4, 12, and 24.
Change from baseline in Visual Function Questionnaire (VFQ-25) scores at Weeks 4, 12, and 24. VFQ-25 score total should increase from the baseline visit to show better visual function at Weeks 4, 12, and 24.
Crystalline Lens Opacity
Time frame: Baseline compared to Weeks 4, 12, and 24.
Change from baseline in crystalline lens opacity at Weeks 4, 12, and 24.
BCDVA
Time frame: Baseline compared to Weeks 4, 12, and 24.
Proportion of subjects gaining ≥5, ≥10, or ≥15 letters from baseline in BCDVA at Weeks 4, 12, and 24.
BCDVA
Time frame: Baseline compared to Weeks 4, 12, and 24.
Proportion of subjects losing ≤5, ≤10, or ≤15 letters from baseline in BCDVA at Weeks 4, 12, and 24.
BCDVA
Time frame: Baseline compared to Weeks 4, 12, and 24.
Proportion of subjects achieving BCDVA ≥0.3, 0.1, or 0.0 Logarithm of the Minimum Angle of Resolution (LogMAR; Snellen: 20/40, 20/25, or 20/20) at Weeks 4, 12, and 24.
2 secondary outcomes
Safety, AEs
Time frame: From the start of use of the IP at Visit 2 (Day 1) to the time the subject is exited after Visit 6 procedures and assessments are conducted. Visit 6 is conducted 2 weeks after the last dose is given at Week 24.
Safety, Clinically Relevant Changes
Time frame: From the start of use of the IP at Visit 2 (Day 1) to the time the subject is exited after Visit 6 procedures and assessments are conducted. Visit 6 is conducted 2 weeks after the last dose is given at Week 24.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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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.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.4% ZOC2017217 in people with Age Related Cataracts, run by Ocusun Ophthalmic Pharmaceutical (Guangzhou) Co., Ltd. at 21 sites in United States.
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 9 inclusion and 30 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: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
BCDVA (time frame: Baseline as compared to Weeks 4, 12, and 24.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2026.