Primary Open Angle GlaucomaPhase 4NCT02017327
Safety and Efficacy Assessment of Monoprost® in Comparison With Lumigan® 0.01 % and Lumigan® 0.03% Unit Dose
A Phase 4 study testing Monoprost, Lumigan 0.01% and Lumigan 0.03% Unit Dose in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Laboratoires Thea at 1 site in France.
Trial summary
Primary objective: The primary objective is to demonstrate the superiority of Monoprost® versus Lumigan® 0.01% and Lumigan® 0.03% Unit Dose in term of safety with respect to the assessment of conjunctival hyperaemia in the worse eye at Day 84. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- Monoprost, Lumigan 0.01% and Lumigan 0.03% Unit Dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 379 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2013to Jul 2016
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥18 years old.
- Written informed consent.
- Association of the 3 following criteria:
- Both eyes have primary open angle glaucoma or ocular hypertension already treated and controlled by mono-therapy of Lumigan® 0.01% since at least 3 months (according to European Glaucoma Society guidelines).
- Intra Ocular Pressure ≤ 18 mm Hg in both eyes.
- With local intolerance signs in at least one eye defined by the association of:
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- 3.1 Hyperaemia = Grade (2) or (3) or (4) following the photographic MacMonnies scale.
- And 3.2.1 Presence of at least 2 symptoms with a level of severity ≥ 1 (= mild or moderate or severe) among the following 5 symptoms: irritation/burning, itching, tearing, eye dryness sensation, foreign body sensation.
- And/Or 3.2.2 Presence of at least 2 signs with a level of severity ≥ 1 (= mild or moderate or severe) among the following 3 signs: superficial punctate keratitis, blepharitis, eyelid skin darkness.
Who cannot join
- - Presence of at least one severe objective sign among the following:
- Global ocular staining with Oxford (0-15) grading scheme >12.
- Blepharitis (Grade 4: Very severe, i.e. eczematiform lesion).
- Any ocular hypertension other than primary ocular hypertension or primary chronic open angle glaucoma (such as congenital, angle closure glaucoma, secondary glaucoma).
- Visual field not performed or not available within the 6 months before inclusion visit.
- Fundus not performed or not available within the 6 months before inclusion visit.
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- Advanced stage of glaucoma:
- Absolute defect in the ten degrees central point of the visual field.
- Severe visual field loss according to the investigator's best judgement.
- Risk of visual field worsening as a consequence of participation in the trial according to the investigator's best judgement.
- Best far corrected visual acuity ≤ 1/10.
- History of trauma, infection, inflammation within the 3 months before inclusion visit.
- Ongoing or known history of ocular allergy and/or uveitis and/or viral infection.
- Severe dry eye (defined by severe epithelial erosions of the cornea and/or use of dry eye medication with a frequency exceeding 8 instillations / day).
- Corneal ulceration.
- Palpebral abnormalities not related to medical treatment study and incompatible with a good evaluation.
- Any abnormality preventing accurate assessment e.g. reliable tonometry measurement, visual field examination.
- Systemic/non ophthalmic/ exclusion criteria
- Non-controlled diabetic patient.
- Known or suspected hypersensitivity to one of the components of the study product.
- Any medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine, neoplastic, haematological; immunosuppressive, infectious diseases, severe psychiatric illness, relevant cardiovascular abnormalities, etc… and/or any complicating factor or structural abnormality, judged by the investigator to be incompatible with the study.
- Specific exclusion criteria for women
- Pregnancy, lactation.
- Childbearing potential woman who is not using a reliable method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant, vaginal ring, patch) and is not surgically sterilised.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy Assessment of Monoprost® in Comparison With Lumigan® 0.01% and Lumigan® 0.03% Unit Dose, in Patients With Primary Open Angle Glaucoma or Ocular Hypertension, Stabilized by Lumigan® 0.01% With Ocular Surface Intolerance
Primary objective:
The primary objective is to demonstrate the superiority of Monoprost® versus Lumigan® 0.01% and Lumigan® 0.03% Unit Dose in term of safety with respect to the assessment of conjunctival hyperaemia in the worse eye at Day 84.
The conjunctival hyperaemia will be scored using the MacMonnies photographic scale (0 to 5).
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Being tested
- Monoprost, Lumigan 0.01%, Lumigan 0.03% Unit Dose
- 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.
MonoprostDrug
Also called Latanoprost 0.005%
Monoprost®: Latanoprost 0.005% ophthalmic preparation is a sterile unpreserved oil-based solution for topical ophthalmic use. It is supplied in 0.30 ml single use polyethylene containers. The batch numbers and reanalysis dates will be stated in the certificate of analysis.
Lumigan 0.01%Drug
Also called Bimatoprost 0.1mg/ml
Lumigan® 0.01%: Bimatoprost eye drop solution is supplied in 3 ml multidose container.
Lumigan 0.03% Unit DoseDrug
Also called Bimatoprost 0.3mg/ML
Lumigan® 0.03% Unit Dose: Bimatoprost eye drop solution is supplied in 0.4 ml single use low density polyethylene (LDPE) containers.
| Study group | Role | What they receive |
|---|---|---|
| Monoprost | Experimental | 1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months. Receives: Drug: Monoprost |
| Lumigan 0.01% | Active comparator | 1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months. Receives: Drug: Lumigan 0.01% |
| Lumigan 0.03% Unit Dose | Active comparator | 1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months. Receives: Drug: Lumigan 0.03% Unit Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety With Respect to the Assessment of Conjunctival Hyperaemia in the Worse Eye
The primary endpoint is the change from baseline of conjunctival hyperaemia assessed on MacMonnies' 6 point ordinal scale, in the worse eye at the D84 visit. The primary statistical hypothesis tested is that Monoprost® is superior to Lumigan® 0.03% Unit Dose with regard to this primary endpoint, i.e. that in the worse eye the decrease from baseline in the MacMonnies 6 point ordinal scale is greater in the Monoprost® treated group than in the Lumigan® 0.03% Unit Dose group at the Day 84 visit.
The conjunctival hyperaemia will be scored using the "McMonnies" photographic scale (0 to 5). The minimum score is 0 corresponding to a low hyperaemia and the maximum score is 5 corresponding to a higher hyperaemia.
The Rows represent the number of participants with a change from Baseline to D84 corresponding to
- "decrease of 3 points"
- "decrease of 2 points"
- "no change",
- "increase of 2 points"
- "increase of 1 point" on Mc Monnies scale
Measured: Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJul 2016
- Study completionJul 2016
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 Primary Open Angle GlaucomaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Thea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christophe Baudouin, Professor, Principal investigator, Hopital des XV-XX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017327
- Sponsor's protocol ID
- LT2345-PIV-02/13
- Other IDs
- 2013-001250-10
- Status last verified
- Feb 2020
- First submitted
- 2 Dec 2013
- Last updated
- 2 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Assessment of Monoprost® in Comparison With Lumigan® 0.01% and Lumigan® 0.03% Unit Dose, in Patients With Primary Open Angle Glaucoma or Ocular Hypertension, Stabilized by Lumigan® 0.01% With Ocular Surface Intolerance
- ClinicalTrials.gov ID
- NCT02017327
- Acronym / sponsor ID
- LT2345-PIV-02/13
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 20 Dec 2013 (estimated)
- Results
- Posted 2 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective:
The primary objective is to demonstrate the superiority of Monoprost® versus Lumigan® 0.01% and Lumigan® 0.03% Unit Dose in term of safety with respect to the assessment of conjunctival hyperaemia in the worse eye at Day 84.
The conjunctival hyperaemia will be scored using the MacMonnies photographic scale (0 to 5).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Monoprost | Experimental | Drug: Monoprost1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months. |
| Lumigan 0.01% | Active comparator | Drug: Lumigan 0.01%1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months. |
| Lumigan 0.03% Unit Dose | Active comparator | Drug: Lumigan 0.03% Unit Dose1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female aged ≥18 years old.
- Written informed consent.
- Association of the 3 following criteria:
- 3.1 Hyperaemia = Grade (2) or (3) or (4) following the photographic MacMonnies scale.
- And 3.2.1 Presence of at least 2 symptoms with a level of severity ≥ 1 (= mild or moderate or severe) among the following 5 symptoms: irritation/burning, itching, tearing, eye dryness sensation, foreign body sensation.
Key exclusion criteria (24 listed)
- - Presence of at least one severe objective sign among the following:
- Any ocular hypertension other than primary ocular hypertension or primary chronic open angle glaucoma (such as congenital, angle closure glaucoma, secondary glaucoma).
- Visual field not performed or not available within the 6 months before inclusion visit.
- Fundus not performed or not available within the 6 months before inclusion visit.
- Advanced stage of glaucoma:
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 |
|---|---|---|
| MonoprostAlso: Latanoprost 0.005%Monoprost®: Latanoprost 0.005% ophthalmic preparation is a sterile unpreserved oil-based solution for topical ophthalmic use. It is supplied in 0.30 ml single use polyethylene containers. The batch numbers and reanalysis dates will be stated in the certificate of analysis. | Drug | Monoprost |
| Lumigan 0.01%Also: Bimatoprost 0.1mg/mlLumigan® 0.01%: Bimatoprost eye drop solution is supplied in 3 ml multidose container. | Drug | Lumigan 0.01% |
| Lumigan 0.03% Unit DoseAlso: Bimatoprost 0.3mg/MLLumigan® 0.03% Unit Dose: Bimatoprost eye drop solution is supplied in 0.4 ml single use low density polyethylene (LDPE) containers. | Drug | Lumigan 0.03% Unit Dose |
Primary outcome
Safety With Respect to the Assessment of Conjunctival Hyperaemia in the Worse Eye
Time frame: Day 84
The primary endpoint is the change from baseline of conjunctival hyperaemia assessed on MacMonnies' 6 point ordinal scale, in the worse eye at the D84 visit. The primary statistical hypothesis tested is that Monoprost® is superior to Lumigan® 0.03% Unit Dose with regard to this primary endpoint, i.e. that in the worse eye the decrease from baseline in the MacMonnies 6 point ordinal scale is greater in the Monoprost® treated group than in the Lumigan® 0.03% Unit Dose group at the Day 84 visit. The conjunctival hyperaemia will be scored using the "McMonnies" photographic scale (0 to 5). The minimum score is 0 corresponding to a low hyperaemia and the maximum score is 5 corresponding to a higher hyperaemia. The Rows represent the number of participants with a change from Baseline to D84 corresponding to * "decrease of 3 points" * "decrease of 2 points" * "no change", * "increase of 2 points" * "increase of 1 point" on Mc Monnies scale
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- 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.
Christophe Baudouin, Professor principal investigator
Hopital des XV-XX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Monoprost, Lumigan 0.01% and Lumigan 0.03% Unit Dose in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Laboratoires Thea 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 9 inclusion and 24 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 2 Apr 2020. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 2 Apr 2020). 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?
Safety With Respect to the Assessment of Conjunctival Hyperaemia in the Worse Eye (time frame: Day 84). 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 2 Apr 2020.