Santen Catioprost - Comparing DE-130A with Xalatan for Glaucoma
Research type
Research Study
Full title
Phase III, Multinational, Multicenter, Investigator-Masked, Randomised, Active-Controlled Trial, comparing the efficacy and safety of DE-130A with Xalatan® in Patients with Open-Angle Glaucoma or Ocular Hypertension over a 3-Month period, followed by a 12-Month Follow-Up with Open-Label DE-130A Treatment
IRAS ID
257583
Contact name
Rupert Bourne
Contact email
Sponsor organisation
Santen SAS
Eudract number
2017-004262-95
Duration of Study in the UK
1 years, 9 months, 24 days
Research summary
Research Summary
The purpose of the study is to test whether DE-130A is as safe and effective as Xalatan at reducing the intraocular pressure (IOP) of patients with Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT).
Approximately 380 patients will be enrolled in the study, which will be made up of 3 sections: The first section will be a wash out phase which will last between 5 days and 5 weeks. During this wash-out phase the patients' usual IOP lowering medication will be replaced by Brinzolamide, in order to remove any effect their previous IOP lowering medication would have had on the results. This treatment of Brinzolamide will continue for between 5 days and 5 weeks, until 5 days before the Baseline Visit, when it will cease. at the Baseline Visit patients will be reviewed against the inclusion criteria; if they fail to meet these criteria they will be removed from the study, whilst if they meet the criteria they will progress to Treatment Period 1.
Treatment Period 1 will involve the patients being randomly assigned to two different groups of equal size. One of these groups will receive Xalatan and the other group will receive DE-130A. Both treatments will take the form of eye drops, with one drop being administered to the affected eye(s) each day. This phase will last 12 weeks and the investigators will not be aware of which patients are receiving which treatments.
Treatment Period 2 will only be applied to the first 130 patients to complete Treatment Period 1 and agree to participate in period 2. This period will last 12 months and the investigators will be aware of which patients are receiving which treatments.
Summary of Results
1. What Was the Study About?
Glaucoma is a common eye disease which may lead to loss of vision. In this disease, the nerve in the back of the eye (called the optic nerve) is damaged. This causes the clear fluid inside the eye (called the aqueous humor) to build up and the pressure inside the eye becomes higher than normal. Ocular hypertension is also a condition where the pressure inside the eye is higher than normal, but there is no obvious damage to the optic nerve. Glaucoma cannot be treated, but the pressure inside the eye can be lowered by taking medications to slow down or stop the damage to the optic nerve.
Some patients receive glaucoma medications that have a preservative called benzalkonium chloride (or BAK for short). Eye drops that have this ingredient may cause some patients to experience discomfort such as dryness, redness, itching or burning on the surface of their eye. These conditions are sometimes called ocular surface disease (or OSD for short).
The researchers in this study are trying to develop better treatments for glaucoma and other conditions that increase the pressure inside the eye, that have fewer side effects and also help improve ocular surface disease. By comparing new medicines to those already proven to treat high pressure in the eye, there will be opportunities for new or better treatments.2. What Happened During the Study
This study was completed in 52 research clinics in Austria, Belgium, Estonia, Finland, France, Germany, Italy, Latvia, Poland, Spain, United Kingdom, Russia, and South Korea between April of 2019 and February of 2022.
This was an active-control study, which means that about half of the study participants received the Test medicine called DE-130A (the medicine that the study was learning about), and the other half received the Control medicine called Xalatan (the medicine that was compared with the Test medicine). Both the Test and Control medicines were eye drops and participants placed 1 drop in each eye at night.
Participants who agreed to be in the study were asked to stop taking any other eye drops that they were already taking before the start of the study (this is called a washout). After the washout, if they still met the study entry criteria, they participated in the study.
There were 2 periods in the study. In the first period (Period 1), the study participants were randomized (this means that they were assigned by chance) to either receive the study Test medicine or the Control medicine, and they were treated for 3 months. This was also considered an investigator-masked study. That means the study doctors did not know which medicine each study participant was receiving. In the second period (Period 2), study participants from Period 1 received only Test medicine DE-130A, and they were treated for 12 months. Period 2 was an open-label study. This means that study participants and study doctors knew which medicine the participants were taking.3. Why Was This Study Needed?
The main question that the study researchers wanted to answer was if the Test eye drop (DE-130A) works as well as an already marketed eye drop (Xalatan) to lower the pressure inside the eye in people who had glaucoma or ocular hypertension. To answer this question, the researchers measured the pressure of the study eye and compared the results between the participants who used the Test and the Control eye drops after 3 months of using the medications.
The researchers also wanted to find out if the Test medicine is safe to use for a longer time period. To answer this question, some participants received the Test medicine for about 12 more months and their eye health and general health were monitored on a regular basis.4. Who Was in This Study?
The participants in this study either had glaucoma or ocular hypertension. Participants were only able to be in the study if they were 18 years of age or older, had good vision in both eyes, and had no other problems or diseases in their eyes that could cause harm. There were 386 participants in Period 1 of whom 137 participated in Period 2. The study participants were between 18 to 88 years of age.5. What Medicines Were Used in the Study?
There were 2 medicines used on this study. Both study medicines included the active medicine latanoprost, which is an eyedrop solution that helps lower the pressure inside the eye. Latanoprost has been approved to be sold around the world for many years and is commonly prescribed to patients with glaucoma and ocular hypertension. The Test medicine DE-130A was a formula of latanoprost that did not include the preservative BAK. The Control medicine Xalatan was a formula of latanoprost with the preservative BAK.
The study participants were asked to place one drop of the study medication in each eye at around 9 o’clock in the evening, every day for 12 weeks.6. What Were Any Adverse Reactions?
An adverse reaction (also called an adverse effect) is an unwanted reaction, effect, or medical problem that happens to the body or parts of the body after taking a medicine. This is called as adverse reaction because the study doctors believe it might have been caused by the study medication.
Some participants in the study experienced adverse reactions after the study medication was used. These are listed on the next page in Table 1 and Table 2. None of the adverse reactions that are listed in these tables were considered serious. An adverse reaction is considered to be “serious” when it is life-threatening, causes long lasting medical problems, or if the patient needs hospital care. Two study participants had to leave the study after experiencing adverse reactions of eye redness, eye irritation, and dry eye sensation that were caused by the study medicine.7. What Were the Results of This Study?
The study results showed that the Test medicine worked as well as Xalatan, which is a medicine often prescribed to lower eye pressure. Both of the Test and Control groups of study participants who received the study medication had a lower average eye pressure after 3 months of use than they did at the start of the study. The results also showed that participants who had damage to their cornea (the clear part that covers the front of the eye) at the beginning of the study, had improvement in their condition after using the Test medicine.8. What Do the Study Results Mean?
The information that was found in this summary helped the researchers better understand how well DE-130A works in lowering the pressure inside the eye. This information will help in the development of a new treatment, which will mean patients with glaucoma or higher pressure in the eye may have more choices for treatments that work and are safe to use. Please keep in mind that these are the results of one study. Other studies with the same investigational medicine may show different results.9. Future Studies
Santen will likely perform future studies with the Test medicine. But the plans or details of these studies are not available yet.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
19/EE/0042
Date of REC Opinion
12 Apr 2019
REC opinion
Further Information Favourable Opinion