Clinical trial NCT05165290: Prospective, Double-masked, Randomized, Multi-center, Active-controlled, Parallel-group, 3-month Study Assessing the Safety & Ocular Hypotensive Efficacy of TC-002 Ophthalmic Solution Compared to Latanoprost Ophthalmic Solution 0.005% in Subjects With Elevated Intraocular Pressure
Official title: Prospective, Double-masked, Randomized, Multi-center, Active-controlled, Parallel-group, 3-month Study Assessing the Safety & Ocular Hypotensive Efficacy of TC-002 Ophthalmic Solution Compared to Latanoprost Ophthalmic Solution 0.005% in Subjects With Elevated Intraocular Pressure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Elevated Intraocular Pressure
Keywords: elevated IOP
open-angle glaucoma
ocular hypertension
Lead sponsor: TearClear Corp
Sponsor class: INDUSTRY
First posted: 2021-12-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, double-masked, randomized, multi-center, active-controlled, parallel-group, 3-month study assessing the safety and ocular hypotensive efficacy of TearClear latanoprost Ophthalmic Solution, 0.005% (TC-002) compared to latanoprost Ophthalmic Solution, 0.005% (LAT) in subjects with elevated intraocular pressure at approximately 20 study sites located in the United States

Detailed description: This is a Phase 3, randomized, investigator-masked, multicenter, parallel-group trial comparing two ophthalmic solution formulations of latanoprost at a fixed dose of 0.005% administered once daily (QD) for 12 weeks.

Approximately 300 subjects will be randomized in this study at approximately 20 sites in the United States (US).

Treatment assignments will be masked to TearClear, study subjects, Investigators and site staff. Because the container closure for the investigational product is different, this study will use an unmasked dosing coordinator at each study site. All clinical trial supplies will be masked by using carton boxes to mask the appearance of the immediate container closure.

At approximately 2 select sites, approximately10% of total randomized subjects will have systemic PK labs drawn.

The study involves 7 clinic visits, including Screening (Visit 1), Randomization (Visit 2) and treatment visits (Visits 3, 5 and 7, during which ophthalmic assessments will occur and IOP will be assessed diurnally. There will be two interim IP dispensation visits (Visits 4 and 6).

Eligibility criteria: Inclusion Criteria:

1. Greater than 18 years old.
2. Have been diagnosed and treated for bilateral open-angle glaucoma or ocular hypertension in both eyes.
3. Currently and for at least 30 days prior to screening, are being treated with a stable dose of latanoprost ophthalmic solution or prostaglandin analog for which there is a documented and positive treatment response with either agent maintained within both eyes.
4. Have best corrected visual acuity (BCVA) via Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) score +0.6 logarithm of the minimum angle of resolution (logMAR) or better in each eye.
5. At Visit 1, have IOP on prostaglandin or prostaglandin analog single therapy ≤ 21mmHg, at Visit 2, have diurnal IOP between 22 and 30 mmHG, inclusive for each eye.
6. In the Investigator's judgment, are able to safely discontinue current ocular hypotensive medication during the washout period.
7. Willing and able to avoid wearing contact lenses from Visit 1 (Screening) and for the duration of the trial.
8. Willing and able to self-administer or have an able person available on a daily basis to assist with administration of study medication.
9. Female subjects must either be incapable of pregnancy because of bilateral oophorectomy, hysterectomy, or bilateral tubal ligation, or be post-menopausal (have been amenorrheic for at least 2 years) or must use an effective (e.g., double-barrier) method of birth control for the duration of the study. Female subjects of childbearing potential must have a negative pregnancy test and not be nursing.
10. Willing and able to comply with all study procedures.

Exclusion Criteria:

1. Causes of glaucoma other than primary open-angle glaucoma, including:

   1. narrow angles (3 quadrants with less than Grade 2 according to Shaffer anterior chamber angle grading system) and subjects with angle closure
   2. clinically significant peripheral anterior synechiae
   3. congenital glaucoma
   4. a history of angle closure in either eye
   5. aphakic glaucoma
   6. traumatic glaucoma
   7. neovascular glaucoma
   8. pigmentary glaucoma
   9. pseudoexfoliative glaucoma
   10. drug-induced glaucoma
2. Using a multi-drop treatment (other than prostaglandin or prostaglandin analog) for IOP-lowering medications.
3. Advanced glaucoma or subjects with a cup/disc ratio greater than 0.8.
4. Have undergone incisional IOP-lowering surgeries a placement or removal of minimally invasive glaucoma implant (MIG) in either eye.
5. Have undergone non-incisional IOP-lowering surgeries within the past 6 months.
6. Used anti-vascular endothelial growth factor (anti-VEGF) within 12 months of screening.
7. Used intraocular, periocular or topical corticosteroids within 60 days of screening.
8. Have received laser surgery for glaucoma (selective laser trabeculoplasty \[SLT\] or argon laser trabeculoplasty \[ALT\]) within 6 months of screening.
9. Have uveitis, iritis or congenital aphakia.
10. Are unwilling to discontinue current glaucoma medication within 30 days of the randomization (Visit 2).
11. Have had intraocular or periocular surgery within the past 3 months.
12. Are non-responsive to topical prostaglandins, prostamides or prostaglandin analogs in the Investigator's judgement.
13. History of previous complicated cataract surgery, or previous refractive keratotomy in either eye.
14. Used miotics and oral/topical carbonic anhydrase inhibitors within 5 days of screening.
15. Have any known hypersensitivity to any components of the formulation or latanoprost.
16. Have participated in a clinical trial for IOP-lowering investigational product or exposure to an IP within the prior 30 days.
17. In the judgement of the Investigator, have previous or currently active clinically significant systemic or ocular disease in either eye that could affect study outcome.

Primary outcomes:
measure: Primary efficacy endpoint is the difference in mean change from baseline (CFB) in IOP
timeFrame: Weeks 2, 6, and 12 at 8:00 AM, 10:00 AM, and 4:00 PM.
Secondary outcomes:
measure: Secondary efficacy endpoints include diurnal (average of 8:00 AM, 10:00 AM, and 4:00 PM measurements) IOP
timeFrame: Weeks 2, 6, and 12.
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Orange County Ophthalmology Medical Group
state: California
city: Glendale
country: United States
facility: Global Research Management
state: California
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates
state: California
city: Rancho Cordova
country: United States
facility: Martel Eye Medical Group
state: California
city: Torrance
country: United States
facility: Wolstan & Goldberg Eye Associates
state: California
city: Westminster
country: United States
facility: Michael K. Tran, MD
state: California
city: Delray Beach
country: United States
facility: Segal Drug Trials
state: Florida
city: Largo
country: United States
facility: Shettle Eye Research Inc.
state: Florida
city: Tampa
country: United States
facility: International Research Center
state: Florida
city: Louisville
country: United States
facility: The Eyecare Institute/Butcherton Clinical Trials
state: Kentucky
city: Rochester
country: United States
facility: Rochester Ophthalmological Group PA
state: New York
city: Cleveland
country: United States
facility: Abrams Eye Center
state: Ohio
city: Cranberry Township
country: United States
facility: Scott & Christie Associates PC
state: Pennsylvania
city: Memphis
country: United States
facility: Total Eye Care P.A.
state: Tennessee
city: El Paso
country: United States
facility: Louis M. Alpern, M.D., M.P.H., P.A.
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: San Antonio
country: United States
facility: R&R Research LLC
state: Texas
city: San Antonio
country: United States
facility: San Antonio Eye Center
state: Texas
Study officials:
References: