T4090 Eye Drops for Glaucoma and Ocular Hypertension

Overseen By Corentin LECAMUS

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Laboratoires Thea

Disqualifiers: Trauma, Infection, Inflammation, Pregnancy, others

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment called T4090 to see if it is safe for people. The study includes a wide range of participants to ensure the treatment does not cause harm.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to ask the trial coordinators for more details.

What data supports the effectiveness of the drug T4090 Eye Drops for treating glaucoma and ocular hypertension?

The study on the dorzolamide/timolol fixed combination (DTFC) shows that combining different components in eye drops can effectively lower intraocular pressure in glaucoma patients, suggesting that T4090 Eye Drops might also be effective if it uses a similar approach. ^{1 2 3 4 5}

Is T4090 Eye Drops safe for use in humans?

There is no specific safety data available for T4090 Eye Drops, but similar treatments like Carteolol and Timolol have been generally safe for most patients with glaucoma, with side effects occurring in a small percentage of cases. ^{6 7 8 9 10}

Eligibility Criteria

This trial is for individuals with open-angle glaucoma or ocular hypertension in both eyes who have signed an informed consent. It's not suitable for those allergic to the trial medication, pregnant or breastfeeding women, or anyone with recent eye trauma or significant inflammation.

Inclusion Criteria

Both of my eyes have been diagnosed with glaucoma or high eye pressure.

Informed consent dated and signed.

Informed consent dated and signed

Exclusion Criteria

Known or suspected hypersensitivity to one of the components of the Investigational Medicinal Product(s)

Pregnancy or breast-feeding

I have not had any serious injuries, infections, or inflammation in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive T4090 or placebo eye drops to assess safety

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• T4090 Eye Drops

Trial Overview The study is testing T4090 eye drops containing Kinezodianone R hydrochloride against a placebo to assess their safety in treating patients with ocular hypertension or glaucoma.

Participant Groups

Group I: T4090 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

named "Vehicle" in the study protocol.

Who Is Running the Clinical Trial?

Laboratoires Thea

Lead Sponsor

Trials

64

Recruited

6,900+

Findings from Research

In a study of 165 patients with glaucoma, 38 experienced adverse effects related to the addition of timolol to their treatment regimen.

Timolol had to be discontinued in 15 patients (9%) due to these side effects, indicating a need for further double-masked studies to better understand the safety profile of timolol in glaucoma therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects experienced by patients taking timolol. McMahon, CD., Shaffer, RN., Hoskins, HD., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Intraocular pressure lowering effect of dorzolamide/timolol fixed combination in patients with glaucoma who were unresponsive to prostaglandin analogs/prostamides. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of tranilast on filtering blebs: a pilot study. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Generic versus brand-name North American topical glaucoma drops. [2016]

4. Germany pubmed.ncbi.nlm.nih.gov

[Prevention of early postoperative increase in intraocular pressure after phacoemulsification. Comparison of different antiglaucoma drugs]. [2019]

5. England pubmed.ncbi.nlm.nih.gov

24-hour intraocular pressure and blood pressure levels with latanoprost/timolol fixed combination versus timolol. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

[Carteolol: general practice-oriented assessment of the effectiveness and tolerance of a new beta-blocker in the treatment of glaucoma]. [2013]

7. Czech Republic pubmed.ncbi.nlm.nih.gov

[Efficacy and tolerability of preservative-free tafluprost 0.0015 % in the treatment of glaucoma and ocular hypertension]. [2014]

8. United States pubmed.ncbi.nlm.nih.gov

Trimolol: effect on intraocular pressure in chronic open-angle glaucoma. [2013]

9. India pubmed.ncbi.nlm.nih.gov

Timolol maleate 0.5% versus timolol maleate in gel forming solution 0.5% (Timolol GFS) in open angle glaucoma in India. Preliminary safety and efficacy study. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

Adverse effects experienced by patients taking timolol. [2019]