Clinical Trials Logo
  1. Home
  2. Glaucoma
  3. NCT06394973
  4. Details
NCT06394973 Clinical Trial

Efficacy and Safety Assessment of T4090 Ophthalmic Solution Versus Rhopressa® Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension

Glaucoma Clinical Trial

Official title:
Efficacy and Safety Assessment of T4090 Ophthalmic Solution (Preservative-free Kinezodianone R HCl 0.2% or 0.3%) Versus Rhopressa® Ophthalmic Solution (Preserved Netarsudil 0.02%) in Patients With Open-angle Glaucoma or Ocular Hypertension

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06394973
Other study ID # LT4090-201
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date June 2024
Est. completion date May 2025

Study information
Verified date April 2024
Source Laboratoires Thea
Contact Corentin LE CAMUS
Phone +33473981436
Email Corentin.LECAMUS@theapharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main purpose is to compare the ocular hypotensive efficacy and safety of two concentrations of T4090 (Kinezodianone R HCl 0.2% and 0.3%) ophthalmic solution with Rhopressa® ophthalmic solution

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 126
Est. completion date May 2025
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Main Inclusion Criteria: - Patient (male or female) =18 years old - Patient with Open Angle Glaucoma or Ocular Hypertension in both eyes - Informed consent dated and signed. Main Exclusion Criteria: - Secondary Open Agle Glaucoma (ex. Pseudoexfoliation, Pigmentary glaucoma) - Advanced stage of glaucoma - History of ocular trauma, eye infection, or/and ocular clinically significant inflammation within the 6 previous months. - Known or suspected hypersensitivity to one of the components of the IMPs or other product used in the clinical study - Pregnancy (confirmed with a positive urine pregnancy test) or breast-feeding.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• T4090 0.2%
1 drop in the conjunctival cul-de-sac of each eye once daily at 8:00 PM (±1 hour) from Day 1 to the day before the End of treatment visit (Visit #5 - Week 7).
• T4090 0.3%
1 drop in the conjunctival cul-de-sac of each eye once daily at 8:00 PM (±1 hour) from Day 1 to the day before the End of treatment visit (Visit #5 - Week 7).
• Rhopressa®
1 drop in the conjunctival cul-de-sac of each eye once daily at 8:00 PM (±1 hour) from Day 1 to the day before the End of treatment visit (Visit #5 - Week 7).

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Laboratoires Thea

Outcome
Type Measure Description Time frame Safety issue
Primary IOP Assessment IOP measurement with calibrated Goldmann applanation tonometer in each eye at three time points (8:00 AM; 10:00 AM; 4:00 PM) by the Investigator. The primary efficacy endpoint is the change from baseline (D1) at Week 7 in the mean diurnal IOP in the study eye.
See also
  Status Clinical Trial Phase
Recruiting NCT06000865 - Glaucoma Rehabilitation With Action viDeo Games and Exercise - GRADE N/A
Recruiting NCT06278597 - Automatic Evaluation of the Anterior Chamber Angle Width by a New Non-contact Optical Device N/A
Active, not recruiting NCT04271709 - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT) N/A
Recruiting NCT03274024 - The Asia Primary Tube Versus Trab (TVT) Study N/A
Completed NCT04552964 - Assessment of the Impact of an add-on and Its Smartphone Application on the Daily Management of Glaucoma N/A
Recruiting NCT01957267 - Functional and Structural Imaging for Glaucoma
Active, not recruiting NCT04624698 - iStent Inject New Enrollment Post-Approval Study N/A
Completed NCT04020705 - The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma N/A
Completed NCT03150160 - Additive Effect of Twice-daily Brinzolamide 1%/Brimonidine 0.2%Combination as an Adjunctive Therapy to Travoprost in Patients With Normal Tension Glaucoma Phase 4
Not yet recruiting NCT05581498 - Glaucoma Exercise as Medicine Study (GEMS). N/A
Recruiting NCT02921568 - Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes N/A
Active, not recruiting NCT02901730 - Clinical Study of LPI With Different Laser Wavelengths N/A
Completed NCT02955849 - A Trial of China Laser and Surgery Study Glaucoma in Rural China Early Phase 1
Recruiting NCT02554214 - Pilot Clinical Trial on a New Adjustable Glaucoma Drainage Device N/A
Recruiting NCT02471105 - Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml Phase 4
Active, not recruiting NCT02390284 - Stop Retinal Ganglion Cell Dysfunction Study Phase 3
Completed NCT02390245 - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study N/A
Completed NCT02653963 - Triamcinolone for Ahmed Glaucoma Valve N/A
Completed NCT02520674 - Glaucoma Screening With Smartphone Ophthalmology N/A
Completed NCT02246764 - Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension Phase 3