Efficacy and Safety Assessment of T4030 Eye Drops versus Ganfort® UD
Research type
Research Study
Full title
Efficacy and Safety Assessment of T4030 Eye Drops versus Ganfort® UD in Ocular Hypertensive or Glaucomatous Patients.
IRAS ID
1003500
Contact name
Francesca Cordeiro
Contact email
Sponsor organisation
Laboratoires THEA
Eudract number
2020-003979-18
Research summary
Research Summary
This is a phase III, international, multicentre, randomised (participants are randomly selected), 2 parallel groups, investigator-masked, 3-month treatment study. The purpose of this study is to see how efficient the drug T4030 is as a treatment for patients with open-angle glaucoma (OAG) or Ocular Hypertension (OHT) compared with the standard (Ganfort® UD). Around 500 participants will be randomised, who have been treated with a first-line monotherapy (prostaglandin or beta-blocker). The participants will be involved in the study for a maximum of 23 weeks, this will include a 4 week (maximum 5 weeks) period of wash-out, 12 weeks (maximum 13 weeks) period of treatment and 4 weeks (maximum 5 weeks) period of follow-up, after last dose. An optional visit can be completed after screening if the investigator deems it necessary.
The participants will be randomised into two groups and will receive T4030 or Ganfort® UD once a day.Summary of Results
"554 participants living in 13 different countries took part in this study. All participants were between 22 and 89 years of age.
People living in India, Russia, Tunisia, Ukraine, the United Kingdom, and 8 countries in the EU took part
This was an investigator-masked study. This means that the study doctor did not know what medicine the participant took. The participant was also told not to discuss the medicine they took with the study doctor. This is done to avoid bias when comparing the 2 medicines.
Participants had an equal chance to receive either study medicine.
This table shows the study medicine the participants received:
T4030 Ganfort® UD
280 participants 274 participants
0.01% bimatoprost and 0.1% timolol 0.03% bimatoprost and 0.5% timolol
T4030 is an eye gel Ganfort® UD is a liquid eye solution
T4030 is a new combination of the 2 medicines that are also used in Ganfort® UD: bimatoprost and timolol.
• Bimatoprost reduces eye pressure by allowing the fluid in the eye to drain better.
• Timolol is thought to lower the amount of eye fluid the body makes.
T4030 contains a lower concentration of each medicine than Ganfort® UD does.
People could take part in this study if they were:
• 18 years of age or older
• diagnosed with OHT or OAG in both eyes
• taking a glaucoma treatment with a single medicine but their doctor thought a combination treatment might be better.
People could not take part in this study if they:
• could not safely discontinue their current glaucoma treatment
• had advanced glaucoma or glaucoma other than OAG in at least 1 eye
The study started in March 2021 and ended in April 2023
The results described here include fewer than the total number of participants who originally joined the study. Some participants did not follow the study instructions exactly, so their data could not be included here.
Researchers found that:
• T4030 reduced the IOP in participants as well as Ganfort® UD.
• Participants in the T4030 group reported slightly fewer side effects than participants in the Ganfort® UD group.
Based on these results, researchers think that in adults with OHT and OAG:
• a dual therapy (such as T4030 and Ganfort® UD) reduces the IOP in adults whose condition did not respond when a single medicine was used.
• a lower amount of bimatoprost and timolol is effective in reducing IOP.
• T4030 and Ganfort® UD are similarly safe to use and were tolerated by the participants.
In this study, the researchers looked at 2 types of side effects:
•Ocular side effects: Health problems related to the study medicine that participants experienced in their eye(s)."REC name
East of Scotland Research Ethics Service REC 2
REC reference
20/ES/0122
Date of REC Opinion
19 Jan 2021
REC opinion
Further Information Favourable Opinion