Is NCT07395986 recruiting in Longmont, CO?

Yes, NCT07395986 is currently recruiting participants at its Longmont, CO location. This age related cataracts clinical trial is actively enrolling qualified participants.

How do I join the age related cataracts clinical trial in Longmont?

To join this clinical trial in Longmont, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Longmont clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Age Related Cataracts Clinical Trial in Longmont, CO

About This Age Related Cataracts Study in Longmont

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.

Sponsor: Ocusun Ophthalmic Pharmaceutical (Guangzhou) Co., Ltd.

Who Can Participate

Inclusion Criteria

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 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.

Exclusion Criteria

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 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. 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:

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Longmont?

Yes, this clinical trial (NCT07395986) has an active research site in Longmont, CO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Age Related Cataracts Treatment Options in Longmont, CO

If you're searching for age related cataracts treatment options in Longmont, CO, this clinical trial (NCT07395986) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Longmont research site is actively enrolling participants for this clinical trial. You'll receive care from experienced age related cataracts specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all age related cataracts clinical trials near you to find additional studies recruiting in your area.

Age Related Cataracts Clinical Trial in Longmont, CO

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