In short
Clinical trials investigating Hypromellose are mainly studying eye drop treatments in dry eye disease. These trials look at safety, symptom relief, and changes in the eye surface in different patient groups, including people using topical hypotensors and people in comparator treatment arms.
Key points
- Clinical trials mentioning Hypromellose are mainly focused on dry eye disease and eye drop comparisons. Most of the studies are Phase 3 trials, which means they are testing treatments in larger groups of patients. The main patient groups include people with dry eye disease and one group of patients using topical hypotensors. The studies measure symptom relief, eye surface staining, corneal staining, and tolerance to treatment. In one dry eye trial, Hypromellose appears as part of the artificial tear comparison arm. One other trial in the data is about a different eye condition, central serous chorioretinopathy, but it does not study Hypromellose.
Clinical trials overview
The trial data show that Hypromellose appears in a dry eye study as part of an artificial tear comparison arm. The main research focus across the trials is not Hypromellose alone, but treatment testing for eye conditions, especially dry eye disease.
All of the Hypromellose-related dry eye trials listed here are Phase 3 studies, which are later-stage trials that usually compare treatments in larger groups of people.
Dry eye disease studies
Two completed Phase 3 trials studied dry eye disease and tested insulin eye drops against artificial tears or other eye treatments. These studies aimed to see whether the treatment could improve dry eye control and reduce symptoms over about 6 months.
One authorised Phase 3 trial studied PRGF eye drops in people with dry eye disease and compared them with artificial tear eye drops containing 0.3% hypromellose. The study brief says the trial was designed to look at both safety and whether PRGF eye drops worked better than the comparison eye drops.
A withdrawn version of the same PRGF study is also listed in the source data, with the same dry eye focus and the same comparison against artificial tear eye drops containing 0.3% hypromellose. Because it was withdrawn, it did not continue as planned.
Other eye trials in the data
One authorised Phase 3 trial studied central serous chorioretinopathy, which is a condition where fluid builds up under or within the retina, the light-sensitive layer at the back of the eye. This trial tested steroid eye drops versus placebo eye drops and measured fluid changes on OCT scans.
This central serous chorioretinopathy study does not mention Hypromellose in its main objective, so it is not a Hypromellose trial in the same way as the dry eye comparison study.
Trial phases, sizes, and status
The dry eye studies in the source data are all interventional trials, meaning the researchers gave a treatment and then measured the results. Their planned enrollment ranged from 54 to 120 people, showing that these were modest-sized clinical studies.
Two dry eye trials were completed, one was authorised, and one was withdrawn. The central serous chorioretinopathy trial was authorised and planned for 40 participants.
Main outcomes researchers measure
The dry eye trials measured changes in corneal staining, which shows how much the cornea is affected by dryness or irritation. They also measured changes in dry eye symptoms and ocular surface staining over time.
One PRGF study used the OSDI questionnaire, which asks patients how dry eye affects their daily life. That study also measured global tolerance, which means how well the treatment was accepted by the investigator and by the patient, and it tracked ocular and systemic adverse events.
The central serous chorioretinopathy trial used OCT scans to measure subretinal and intraretinal fluid, which are fluid collections in or under the retina. Its main outcome was the change in that fluid after four weeks of treatment.
Who could join these studies
The main target population was people with dry eye disease, including patients with moderate to severe disease in one completed trial. One completed trial specifically studied patients with topical hypotensors, meaning people already using eye drops that lower eye pressure.
The PRGF trial also focused on people with dry eye disease and compared treatment with artificial tear eye drops containing 0.3% hypromellose. The central serous chorioretinopathy study targeted people with that separate retinal condition, not dry eye disease.