Open-Angle Glaucoma or Ocular HypertensionPhase 3NCT04133311
A Phase III Multinational Multicenter Investigator-Masked Randomized Active-Controlled Trial Comparing the Efficacy and Safety of DE-130A With Xalatan® in Patients With Open-Angle Glaucoma or Ocular Hypertension
A Phase 3 study testing DE-130A, Xalatan® and DE-130A/DE-130A in people with Open-Angle Glaucoma or Ocular Hypertension and Ocular Surface Disease, run by Santen SAS at 1 site in France.
Trial summary
A Phase III, Multinational, Multicenter, Investigator-Masked, Randomized, 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-Angle Glaucoma or Ocular Hypertension, Ocular Surface Disease
- What is being tested?
- DE-130A, Xalatan® and DE-130A/DE-130A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 1 siteFrance
- Study dates
- 10 Apr 2019to 26 Oct 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18 years of age or older
- The patient has signed and dated a written informed consent form and any required privacy authorization prior to the conduct of any study procedures.
- Diagnosis of OAG (primary open angle glaucoma, pseudo exfoliative glaucoma, or pigmentary glaucoma), or OHT in eligible eye(s) currently on monotherapy.
- Unilateral OAG, or OHT are permissible as long as the physician does not anticipate significant IOP changes to the fellow eye that would require treatment during the duration of the study.
- Current treatment with monotherapy for OAG or OHT with a controlled IOP ≤ 18 mmHg in each eye (pre-washout).
- Stable visual field (based on at least two visual fields available within the last 18 months prior to screening, including one in the last 6 months; A visual field test will be performed at screening if not already performed within the last 6 months prior to screening) in each eye.
Show all 19Show fewer
- Post-washout IOP ≥ 22 mmHg in at least one eye (defined at baseline visit [Day 1] by IOP measurement at both 9:00 am ± 1 hour and 4:00 pm ±1 hour)
- Post-washout IOP ≤ 32 mmHg (defined at baseline visit [Day 1] by IOP measurement at both 9:00 am ±1 hour and 4:00 pm ±1 hour) in both eyes.
- Ability to discontinue their current topical IOP-lowering medication for the required washout period. Washout periods should be as follows;
- Prostaglandin analogs = 4 weeks
- Topical beta blockers ≥ 3 weeks and ≤ 4 weeks
- Topical carbonic anhydrase inhibitors ≥ 5 days and ≤ 4 weeks
- All other IOP lowering medication ≥ 2 weeks and ≤ 4 weeks
- Snellen best corrected visual acuity score of 20/100 or better in each eye
- Patient must be willing to discontinue wearing contact lenses during the study.
- Adequate health for study participation as determined by the investigator
- In the opinion of the investigator, the patient is capable of understanding and complying with protocol requirements
- Patient must be willing and able to undergo and return for scheduled study-related examinations.
- -
Who cannot join
- Any form of glaucoma other than primary open angle glaucoma, pseudo exfoliative glaucoma, and pigmentary glaucoma in either eye.
- IOP at any time point during the Screening or Baseline visits (Visits 1 or 2) of > 32 mmHg in either eye.
- Current treatment for glaucoma with a fixed-combination therapy or more than one drug in either eye or with an oral drug within 6 months prior to screening.
- Corneal abnormalities that would interfere with accurate IOP readings with an applanation tonometer in either eye.
- Central corneal thickness ≤ 480 µm or ≥ 600 µm in either eye (historical data or at the screening visit).
- Significant visual field loss (absolute defect in the 10° central point or mean deviation worse than -12 dB) or progressive field loss during the year before screening in either.
Show all 27Show fewer
- Significant optic nerve abnormality, other than glaucomatous abnormalities in the opinion of the investigator as determined by ophthalmoscopy in either eye.
- Significant changes of the optic neuropathy (e.g. increase cupping since the last examination, optic nerve hemorrhage) in either eye.
- Inability to visualize the patient's optic nerve in either eye.
- Gonioscopy consistent with potential angle closure glaucoma in either eye.
- Patients with severe blepharitis and/or Meibomian Gland Disease (MGD). Patients enrolled with mild to moderate blepharitis and/or MGD should be treated as appropriate during the study in either eye.
- Use of oral or topical ophthalmic steroid within the past 14 days from screening date, or anticipated need for ocular steroid treatment during the study in either eye.
- Use of intravitreal or peribulbar injection of depot steroid or placement of an intravitreal steroid implant within the past 3 months from screening date in either eye.
- Known allergy or sensitivity to the study medications.
- Active or expected ocular allergy during period 1.
- Any active ocular disease (e.g. uveitis, ocular infection, severe dry eye with CFS grade 4 or more on the modified Oxford scale) in either eye. Patients may have mild cataracts, age-related maculopathy or background diabetic retinopathy if, in the opinion of the Investigator, it would not interfere with the conduct of the study.
- Intraocular surgery within 6 months prior to screening in either eye.
- Past history of any filtering surgery for glaucoma in either eye.
- Refractive surgery of any type within 1 year prior to screening in either eye.
- Uncontrolled systemic disease of any type.
- Anticipated alteration in chronic therapy with or introduction of agents known to have a substantial effect on IOP (e.g., alpha-adrenergic agonists, beta-adrenergic antagonists, calcium channel blockers, ACE inhibitors and/or angiotensin II receptor blockers), unless the subject and the medication dosage have been stable for three months prior to the screening visit and the dosage is not expected to change during the study.
- Anticipated change in dosage of or introduction of new medications for chronic cardiac, pulmonary or hypertensive conditions.
- Females who are pregnant or lactating and females of child-bearing potential who are not using a medically acceptable, highly effective method of birth control.
- Current enrolment in an investigational drug or device study or participation in such a study within 30 days prior to screening.
- History of drug or alcohol abuse.
- Patient has any condition or situation that, in the Investigator's opinion, might confound the results of the study, may put the patient at significant risk or might interfere with the patient's ability to participate in the study.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Multinational, Multicenter, Investigator-Masked, Randomized, 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.
A Phase III, Multinational, Multicenter, Investigator-Masked, Randomized, 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.
Read the detailed description
Phase III, prospective, interventional, multinational, multicentre, investigator-masked, randomized, active-controlled trial
Study duration:
- 5 days to 5-week washout period
- 15 months for the first 130 patients
- 12 weeks for the next 250 patients
Patients will attend 6 visits following the wash-out phase (up to 5 weeks):
- Period 1 (3-month investigator-masked treatment period, DE-130A vs Xalatan®): Randomization/Baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days)
- Period 2 (12-month follow-up from Week 12, open-label DE-130A treatment for the first 130 patients who complete their week 12 visit and agree to participate in the open-label period of the study): Month 6 (± 7days), Month 9 (±7 days) and Month 15 (± 1 week) visits.
- Being tested
- DE-130A, Xalatan®, DE-130A/DE-130A, Xalatan®/DE-130A
- Keywords
- IOP, OSD
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DE-130ADrug
Also called Catiolanze®
Latanoprost 50 microg/ml eye drops emulsion, preservative-free eye drops emulsion in single-dose containers.
Xalatan®Drug
Latanoprost 50 microg/ml eye drops solution, eye drops in 2.5 ml dropper containers.
DE-130A/DE-130ADrug
Also called Catiolanze®
After Week 12, received DE-130A continuously.
Xalatan®/DE-130ADrug
Also called Catiolanze®
From week 12 onwards, DE-130A was continued to be administered instead of Xalatan®.
| Study group | Role | What they receive |
|---|---|---|
| DE-130A | Experimental | Instillation of one drop, once daily in the evening (9 pm ±1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT Receives: Drug: DE-130A |
| Xalatan® | Active comparator | Instillation of one drop, once daily in the evening (9 pm ± 1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT Receives: Drug: Xalatan® |
| DE-130A/DE-130A | Other | After 12 weeks, continue to use DE-130A once daily for an additional 12 months. Receives: Drug: DE-130A/DE-130A |
| Xalatan®/DE-130A | Other | After 12 weeks, use DE-130A instead of Xalatan® once daily for an additional 12 months. Receives: Drug: Xalatan®/DE-130A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure (IOP) Change (mmHg) at Week 12
Intraocular Pressure (IOP) change from baseline peak (mmHg). IOP was measured using calibrated Goldman applanation tonometer in the morning (9:00 am ± 1 hour). Analysis using Mixed-Effects Model for Repeated Measures (MMRM).
Measured: Week 12 (09:00) peak timepoint
Intraocular Pressure (IOP) Change (mmHg) at Week 12
Intraocular Pressure (IOP) change from baseline trough (mmHg). IOP was measured using calibrated Goldman applanation tonometer in the afternoon (4:00 pm ± 1 hour). Analysis using Mixed-Effects Model for Repeated Measures (MMRM).
Measured: Week 12 (16:00) trough timepoint
Secondary outcomes (2)
Corneal Fluorescein Staining (CFS) Change From Baseline (First Key Secondary Endpoint)
CFS Change from baseline in participants with baseline CFS score ≥ 1 at Week 12
Staining using fluorescein were graded using the Modified Oxford scale (7-point ordinal scale, score 0, 0.5, and 1 to 5 per area for cornea and conjunctiva separately) as shown below:
- Score = 0: No staining dots
- Score = 0.5: One staining dot per area
- Score = 1: More staining dot per area than score 0.5
- Score = 2: More staining dot per area than score 1
- Score = 3: More staining dot per area than score 2
- Score = 4: More staining dot per area than score 3
- Score = 5: More staining dot per area than score 4
A Mixed-Effects Model for Repeated Measures (MMRM) was fitted to the CFS change from baseline at each visit.
Measured: Week 12
Ocular Surface Disease (OSD) Symptoms (Average of 3 Symptoms); Second Key Secondary Endpoint
Change from baseline in OSD symptom score (average of 3 symptoms: dry eye sensation, blurred/poor vision and burning/stinging/itching) in the study eye at Week 12 in patients with baseline symptom average score>0.
Ocular symptoms were graded on a 5-point scale as shown below:
- Scale = 0: Absent
- Scale = 1: Mild
- Scale = 2: Moderate
- Scale = 3: Severe
- Scale = 4: Very severe
Least Square Means and p-values were obtained by fitting a Mixed-Effects Model for Repeated Measures (MMRM) model to the Ocular Surface Disease (OSD) average change from baseline at each visit.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start10 Apr 2019
- Primary completion3 Feb 2022
- Study completion26 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Open-Angle Glaucoma or Ocular HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 386 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santen SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Sebastien Garrigue, PhD, Study chair, Santen SAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133311
- Sponsor's protocol ID
- 0130A01SA
- Status last verified
- May 2024
- First submitted
- 4 Oct 2019
- Last updated
- 28 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multinational, Multicenter, Investigator-Masked, Randomized, 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.
- ClinicalTrials.gov ID
- NCT04133311
- Acronym / sponsor ID
- 0130A01SA
- Keywords
- IOP, OSD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Santen SASIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 3 Feb 2022 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 21 Oct 2019 (actual)
- Results
- Posted 28 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase III, Multinational, Multicenter, Investigator-Masked, Randomized, 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.
Detailed description
Phase III, prospective, interventional, multinational, multicentre, investigator-masked, randomized, active-controlled trial
Study duration:
- 5 days to 5-week washout period
- 15 months for the first 130 patients
- 12 weeks for the next 250 patients
Patients will attend 6 visits following the wash-out phase (up to 5 weeks):
- Period 1 (3-month investigator-masked treatment period, DE-130A vs Xalatan®): Randomization/Baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days)
- Period 2 (12-month follow-up from Week 12, open-label DE-130A treatment for the first 130 patients who complete their week 12 visit and agree to participate in the open-label period of the study): Month 6 (± 7days), Month 9 (±7 days) and Month 15 (± 1 week) visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DE-130A | Experimental | Drug: DE-130AInstillation of one drop, once daily in the evening (9 pm ±1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT |
| Xalatan® | Active comparator | Drug: Xalatan®Instillation of one drop, once daily in the evening (9 pm ± 1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT |
| DE-130A/DE-130A | Other | Drug: DE-130A/DE-130AAfter 12 weeks, continue to use DE-130A once daily for an additional 12 months. |
| Xalatan®/DE-130A | Other | Drug: Xalatan®/DE-130AAfter 12 weeks, use DE-130A instead of Xalatan® once daily for an additional 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Male or female, 18 years of age or older
- The patient has signed and dated a written informed consent form and any required privacy authorization prior to the conduct of any study procedures.
- Diagnosis of OAG (primary open angle glaucoma, pseudo exfoliative glaucoma, or pigmentary glaucoma), or OHT in eligible eye(s) currently on monotherapy.
- Unilateral OAG, or OHT are permissible as long as the physician does not anticipate significant IOP changes to the fellow eye that would require treatment during the duration of the study.
- Current treatment with monotherapy for OAG or OHT with a controlled IOP ≤ 18 mmHg in each eye (pre-washout).
Key exclusion criteria (27 listed)
- Any form of glaucoma other than primary open angle glaucoma, pseudo exfoliative glaucoma, and pigmentary glaucoma in either eye.
- IOP at any time point during the Screening or Baseline visits (Visits 1 or 2) of > 32 mmHg in either eye.
- Current treatment for glaucoma with a fixed-combination therapy or more than one drug in either eye or with an oral drug within 6 months prior to screening.
- Corneal abnormalities that would interfere with accurate IOP readings with an applanation tonometer in either eye.
- Central corneal thickness ≤ 480 µm or ≥ 600 µm in either eye (historical data or at the screening visit).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DE-130AAlso: Catiolanze®Latanoprost 50 microg/ml eye drops emulsion, preservative-free eye drops emulsion in single-dose containers. | Drug | DE-130A |
| Xalatan®Latanoprost 50 microg/ml eye drops solution, eye drops in 2.5 ml dropper containers. | Drug | Xalatan® |
| DE-130A/DE-130AAlso: Catiolanze®After Week 12, received DE-130A continuously. | Drug | DE-130A/DE-130A |
| Xalatan®/DE-130AAlso: Catiolanze®From week 12 onwards, DE-130A was continued to be administered instead of Xalatan®. | Drug | Xalatan®/DE-130A |
Primary outcome
Intraocular Pressure (IOP) Change (mmHg) at Week 12
Time frame: Week 12 (09:00) peak timepoint
Intraocular Pressure (IOP) change from baseline peak (mmHg). IOP was measured using calibrated Goldman applanation tonometer in the morning (9:00 am ± 1 hour). Analysis using Mixed-Effects Model for Repeated Measures (MMRM).
Intraocular Pressure (IOP) Change (mmHg) at Week 12
Time frame: Week 12 (16:00) trough timepoint
Intraocular Pressure (IOP) change from baseline trough (mmHg). IOP was measured using calibrated Goldman applanation tonometer in the afternoon (4:00 pm ± 1 hour). Analysis using Mixed-Effects Model for Repeated Measures (MMRM).
2 secondary outcomes
Corneal Fluorescein Staining (CFS) Change From Baseline (First Key Secondary Endpoint)
Time frame: Week 12
Ocular Surface Disease (OSD) Symptoms (Average of 3 Symptoms); Second Key Secondary Endpoint
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Sebastien Garrigue, PhD study chair
Santen SAS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DE-130A, Xalatan® and DE-130A/DE-130A in people with Open-Angle Glaucoma or Ocular Hypertension and Ocular Surface Disease, run by Santen SAS at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular Pressure (IOP) Change (mmHg) at Week 12 (time frame: Week 12 (09:00) peak timepoint). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024; AzTrials last refreshed its copy on 30 Oct 2026.