A study to assess the effectiveness of Roclanda (Latanoprost/Netarsudil fixed dose combination) in reducing pressure inside the eye for adults with glaucoma or ocular hypertension
| ISRCTN | ISRCTN17477081 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17477081 |
| Integrated Research Application System (IRAS) | 369113 |
| Central Portfolio Management System (CPMS) | 72791 |
| Sponsor | Santen (United Kingdom) |
| Funder | Santen |
- Submission date
- 03/06/2026
- Registration date
- 18/06/2026
- Last edited
- 04/06/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Glaucoma is a common eye condition that can lead to permanent vision loss if it is not treated. Ocular hypertension means raised pressure inside the eye and increases the risk of developing glaucoma. This study looks at a medicine called Roclanda, which combines two treatments, latanoprost and netarsudil. These medicines help fluid drain from the eye, lowering eye pressure. The aim of the study is to see how well this treatment works and how safe it is for people in routine NHS care who have not responded well to previous single-drug treatment
Who can participate?
Adults aged 18 years or older who have been diagnosed with primary open-angle glaucoma or ocular hypertension may take part. Participants must already have tried a single treatment to lower eye pressure that did not work well enough. They must also have been prescribed the study treatment as part of their usual care and be able to give consent to take part
What does the study involve?
This is an observational study, which means no extra treatment or hospital visits are required. Participants will receive their usual care and treatment as prescribed by their doctor. Researchers will collect information from routine clinic visits over a period of up to 3 months. The study does not change the care patients receive and does not require extra tests
What are the possible benefits and risks of participating?
Participants may benefit from receiving a treatment that could better control their eye pressure. The study may also help improve care for future patients with glaucoma or ocular hypertension. As the treatment is already approved and used in routine care, the risks are those normally linked with this medicine. These may include eye irritation or redness, but no additional risks are expected from taking part in the study itself
Where is the study run from?
The study is being carried out in NHS hospitals across England, including sites in London, Leicester, Manchester, Liverpool, York, and Newcastle
When is the study starting and how long is it expected to run for?
April 2026 to October 2026.
Who is funding the study?
Santen (UK)
Who is the main contact?
Ms Julia Martin, julia.martin@santen.com
Mr Jonathan Clarke, jonathan.clarke8@nhs.net
Contact information
Public, Scientific
Santen UK Ltd, Salisbury Hall
St Albans
AL2 1BU
United Kingdom
| Phone | +44 1727 615110 |
|---|---|
| julia.martin@santen.com |
Principal investigator, Scientific
Moorfields Eye Hospital
City Road
London
EC1V 2PD
United Kingdom
| Phone | +44 2072533411 |
|---|---|
| jonathan.clarke8@nhs.net |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Cohort study |
| Scientific title | PRECISION - A Prospective obseRvational study to assEss the real-world effeCtiveness and tolerability of Latanoprost/NetarsudIl fixed doSe combination in reducing Intraocular pressure in adult patients with primary Open-angle glaucoma or ocular hypertensioN |
| Study acronym | PRECISION |
| Study objectives | The primary objective in this study is to assess the effectiveness of LAT/NET FDC at 3 months in reducing IOP in adult patients with POAG or OHT, who did not respond sufficiently to monotherapy with a PGA or netarsudil in routine practice The secondary objectives in this study are: 1. To assess the short-term effectiveness of LAT/NET FDC at 6 weeks in reducing intraocular pressure in adult patients with primary open-angle glaucoma or ocular hypertension 2. To determine the proportion of treatment responders at 3 months 3. To describe the change in intraocular pressure following initiation of LAT/NET FDC in patients with normal-range baseline intraocular pressure of 20 mmHg or lower 4. To assess the change in eye symptoms score from baseline following LAT/NET FDC use at 3 months using the PNO425 glaucoma symptom scale questionnaire 5. To assess clinician satisfaction of LAT/NET FDC at 3 months using the PNO425 clinician assessment of treatment satisfaction and tolerability questionnaire 6. To assess the tolerability of LAT/NET FDC after 3 months of treatment using the PNO425 clinician assessment of treatment satisfaction and tolerability questionnaire 7. To describe the interval between the diagnosis of primary open-angle glaucoma or ocular hypertension and initiation of LAT/NET FDC 8. To describe the prior treatments for primary open-angle glaucoma or ocular hypertension 9. To assess the proportion of patients discontinuing LAT/NET FDC treatment and reasons for discontinuation 10. To assess the safety of LAT/NET FDC in the treatment of primary open-angle glaucoma or ocular hypertension in routine clinical practice 11. To assess the clinical signs and severity of bulbar conjunctival hyperaemia during treatment with LAT/NET FDC stratified by clinician reported aetiology 12. To describe the presence of cornea verticillata during treatment with LAT/NET FDC 13. To describe participants’ socio-demographic characteristics |
| Ethics approval(s) |
Approved 19/03/2026, London - Queen Square Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 20 7104 8000; queensquare.rec@hra.nhs.uk), ref: 26/PR/0246 |
| Health condition(s) or problem(s) studied | Primary open angle glaucoma and ocular hypertension |
| Methodology | This non-interventional study will observe participants for up to 3 months from the start of their LAT/NET FDC treatment, or until they withdraw consent, switch to another treatment, become pregnant, pass away, or are lost to follow-up. During this period, data will be collected from routine visits and usual assessments with no extra visits resulting from inclusion into the study. |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 31/10/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 110 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. A diagnosis of primary open-angle glaucoma (POAG) or ocular hypertension (OHT) 2. Patient aged ≥ 18 years 3. Have previously received monotherapy with a prostaglandin analogue or netarsudil which has provided insufficient IOP reduction 4. Patients for whom the decision to initiate treatment with LAT/NET FDC was made as part of routine clinical practice and prior to study inclusion 5. Signed informed patient consent before the start of data collection |
| Key exclusion criteria | 1. Previously received combination therapy of topical IOP-lowering medications (including a fixed dose combination) 2. Patient is pregnant, and/or lactating, or planning pregnancy in the following 3 months 3. Contraindications as listed in the SmPC 4. Participation in an investigational programme with interventions outside of routine clinical practice within 30 days prior to enrolment 5. Previous treatment of the study eye with laser in the last 90 days prior to enrolment 6. Patient is listed for laser treatment in the study eye within the next 90 days after enrolment 7. Has a condition or be in a situation that, in the Investigator’s opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient’s study participation |
| Date of first enrolment | 14/04/2026 |
| Date of final enrolment | 31/07/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Leicester
LE1 5WW
England
Manchester
M13 9WL
England
Prescot Street
Liverpool
L7 8XP
England
Wigginton Road
York
YO31 8HE
England
Newcastle upon Tyne
NE1 4LP
England
London
EC1V 2PD
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
04/06/2026: Trial's existence confirmed by NHS HRA.
