A Multicenter, Randomized, Double-Masked, Placebo-Controlled Pilot Study to Evaluate the Efficacy and Safety of ZOC2017217 in Subjects With Age-Related Cataract
Purpose
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.
Condition
- Age Related Cataracts
Eligibility
- Eligible Ages
- Over 50 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Inclusion Criteria: 1. Are ≥50 years of age. 2. Willing and able to provide informed consent and provide relevant privacy authorization(s). 3. Willing and able to comply with study requirements and visit schedule. 4. Able to successfully administer ophthalmic solution or have an appropriate designee (e.g., family member, health care professional) who can administer ophthalmic solution. 5. Have high-contrast BCDVA under photopic conditions ≥35 letters and ≤67 letters at Visit 1 (Screening). 6. Have calculated baseline BCDVA at Visit 2 (Randomization; Baseline; Day 1) that simultaneously meets Randomization Criteria. 7. 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. A. C < 5.0 B. N < 5.0 (both nuclear opalescence [NO] and nuclear color [NC]) C. P < 1.0 8. Have, in the opinion of the Investigator, sufficiently clear ocular media and adequate pupillary dilation to permit quality fundus imaging.
Exclusion Criteria
- Ocular Exclusion Criteria: Study Eye: 1. Have a history of ocular trauma. 2. 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. 3. Have, in the opinion of the Investigator, a cataract other than age-related cataract (e.g., traumatic, concurrent, metabolic, drug and toxic, radiation). 4. 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: 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) 5. Have overall CFS >3. 6. 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: 7. Have high-contrast BCDVA under photopic conditions ≤19 letters. Either Eye: 8. 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. 9. Have newly developed or not stably controlled uveitis within the 6 months prior to Visit 1 (Screening). 10. Unwilling or unable to discontinue wearing contact lenses 14 days prior to Visit 2 (Randomization; Baseline; Day 1), and during the study conduct. 11. 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. A. 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. C. Chlorpromazine or corticosteroids that may aggravate crystalline lens opacity. Note: Topical non-ocular corticosteroids are allowed. General Exclusion Criteria: 12. 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). 13. Have diabetes mellitus with HbA1c ≥7.5%. 14. 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 15. 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. 16. Are pregnant, nursing, or planning a pregnancy during the study. 17. Unwilling or unable to use an acceptable method of contraception throughout the study if a woman of childbearing potential (WOCBP). 18. Unwilling or unable to use an acceptable method of contraception throughout the study if a male sexual partner of a WOCBP. 19. Have a family member or household member enrolled in the study. 20. Have any condition, in the opinion of the Investigator, that makes the subject unsuitable for study participation.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Control |
Drug with no active ingredients |
|
|
Experimental Active |
ZOC2017217 |
|
Recruiting Locations
Catalina Eye
Tucson, Arizona 85712
Tucson, Arizona 85712
Global Research Management
Glendale, California 91204
Glendale, California 91204
Inland Eye Specialists
Hemet, California 92545
Hemet, California 92545
United Medical Research Institute
Inglewood, California 90301
Inglewood, California 90301
North Bay Eye Associates, Inc.
Petaluma, California 94954
Petaluma, California 94954
East West Eye Institute - Torrance
Torrance, California 90505
Torrance, California 90505
Advanced Vision Research Institute
Longmont, Colorado 80503
Longmont, Colorado 80503
Rand Eye Institute
Deerfield Beach, Florida 33064
Deerfield Beach, Florida 33064
Levenson Eye Associates
Jacksonville, Florida 32204
Jacksonville, Florida 32204
Clayton Eye Clinical Research, LLC
Morrow, Georgia 30260
Morrow, Georgia 30260
Springfield Clinic
Springfield, Illinois 62703
Springfield, Illinois 62703
Oculus Research - Cary
Cary, North Carolina 27518
Cary, North Carolina 27518
Bergstrom Eye Research
Fargo, North Dakota 58103
Fargo, North Dakota 58103
Cincinnati Eye Institute - Blue Ash
Blue Ash, Ohio 45242
Blue Ash, Ohio 45242
Valley Retina Institute P.A.
Laredo, Texas 78041
Laredo, Texas 78041
Valley Retina Institute P.A.
McAllen, Texas 78503
McAllen, Texas 78503
R and R Eye Research, LLC
San Antonio, Texas 78229
San Antonio, Texas 78229
More Details
- Status
- Recruiting
- Sponsor
- Ocusun Ophthalmic Pharmaceutical (Guangzhou) Co., Ltd.