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Tests treatment safety and results for Age Related Cataracts
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
What this study is testing
What is 0.4% ZOC2017217?
0.4% ZOC2017217 is an investigational medicine, being studied as a potential treatment for age related cataracts.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- 1. 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...
- Have high-contrast BCDVA under photopic conditions ≥35 letters and ≤67 letters at Visit 1 (Screening).
You likely can't join if
- 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...
- Have, in the opinion of the Investigator, a cataract other than age-related cataract (e.g., traumatic, concurrent, metabolic, drug and toxic...
- Have, in the opinion of the Investigator, any ocular disease or condition that is not stably controlled or is likely to affect central vision...
- Have overall CFS \>3.
See the full eligibility criteria
- 1. 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.
- 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...
- Have, in the opinion of the Investigator, sufficiently clear ocular media and adequate pupillary dilation to permit quality fundus imaging.
- 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: Glaucoma Elevated IOP (e.g., ≥30 mmHg) Optic...
- 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...
- 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 people who commit to not undergoing additional cataract surgery during...
- 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. A. Other ocular surgeries that may...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Tucson, Arizona, United States
- Glendale, California, United States
- Hemet, California, United States
- Inglewood, California, United States
- Petaluma, California, United States
- Torrance, California, United States
- Grand Junction, Colorado, United States
- Longmont, Colorado, United States
- Deerfield Beach, Florida, United States
- Jacksonville, Florida, United States
- Morrow, Georgia, United States
- Springfield, Illinois, United States
- Cary, North Carolina, United States
- Fargo, North Dakota, United States
- Blue Ash, Ohio, United States
- Eugene, Oregon, United States
- Erie, Pennsylvania, United States
- Laredo, Texas, United States
- McAllen, Texas, United States
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Tucson, Arizona, United States; Glendale, California, United States; Hemet, California, United States; Inglewood, California, United States; Petaluma, California, United States and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.