120 Participants Needed

T4090 Eye Drops for Glaucoma and Ocular Hypertension

CL
Overseen ByCorentin LECAMUS
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Laboratoires Thea

What You Need to Know Before You Apply

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.

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.12345

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.678910

Are You a Good Fit for This Trial?

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
See 1 more

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: T4090Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Laboratoires Thea

Lead Sponsor

Trials
64
Recruited
6,900+

Published Research Related to This Trial

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

Citations

Intraocular pressure lowering effect of dorzolamide/timolol fixed combination in patients with glaucoma who were unresponsive to prostaglandin analogs/prostamides. [2013]
Effects of tranilast on filtering blebs: a pilot study. [2019]
Generic versus brand-name North American topical glaucoma drops. [2016]
[Prevention of early postoperative increase in intraocular pressure after phacoemulsification. Comparison of different antiglaucoma drugs]. [2019]
24-hour intraocular pressure and blood pressure levels with latanoprost/timolol fixed combination versus timolol. [2018]
[Carteolol: general practice-oriented assessment of the effectiveness and tolerance of a new beta-blocker in the treatment of glaucoma]. [2013]
7.Czech Republicpubmed.ncbi.nlm.nih.gov
[Efficacy and tolerability of preservative-free tafluprost 0.0015 % in the treatment of glaucoma and ocular hypertension]. [2014]
Trimolol: effect on intraocular pressure in chronic open-angle glaucoma. [2013]
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 Statespubmed.ncbi.nlm.nih.gov
Adverse effects experienced by patients taking timolol. [2019]
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