- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02017327
Safety and Efficacy Assessment of Monoprost® in Comparison With Lumigan® 0.01 % and Lumigan® 0.03% Unit Dose
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Clermont ferrand, France, 63000
- Laboratoires Thea
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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:
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.
Exclusion Criteria:
- 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.
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Monoprost
1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.
|
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.
Other Names:
|
Active Comparator: Lumigan 0.01%
1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.
|
Lumigan® 0.01%: Bimatoprost eye drop solution is supplied in 3 ml multidose container.
Other Names:
|
Active Comparator: Lumigan 0.03% Unit Dose
1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.
|
Lumigan® 0.03% Unit Dose: Bimatoprost eye drop solution is supplied in 0.4 ml single use low density polyethylene (LDPE) containers.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 84
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christophe Baudouin, Professor, Hôpital des XV-XX
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LT2345-PIV-02/13
- 2013-001250-10 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Primary Open Angle Glaucoma
-
Omar SaidCompletedGlaucoma,Primary Open-Angle ,Primary Angle ClosureEgypt
-
Peking UniversityRecruitingPrimary Open Angle Glaucoma | Ocular Hypertension | Primary Open Angle Glaucoma of Both Eyes | Primary Open-Angle Glaucoma, Unspecified Eye | Suspect GlaucomaChina
-
Glaucot Teknoloji Anonim SirketiRecruitingPrimary Open-Angle GlaucomaTurkey
-
China Medical University HospitalCompletedEffect of Acupuncture on Visual Acuity and Visual Field in Patients With Primary Open-angle GlaucomaPrimary Open-angle GlaucomaTaiwan
-
InnFocus Inc.CompletedPrimary Open-angle GlaucomaSpain, United States, United Kingdom, France, Italy
-
Glaukos CorporationTerminatedPrimary Open-Angle GlaucomaUnited States
-
Rehab mahmoud abdelhamid mohamedCairo UniversityCompletedPrimary Open-angle GlaucomaEgypt
-
Cairo UniversityUniversity of LuebeckUnknown
-
Xiaodong ZhouCompletedPrimary Open-angle Glaucoma
-
Qlaris Bio, Inc.RecruitingPrimary Open Angle Glaucoma of Both Eyes | Primary Open Angle Glaucoma (POAG) | Primary Open-Angle Glaucoma, Unspecified Eye | Ocular Hypertension (OHT)United States
Clinical Trials on Monoprost
-
Rigshospitalet, DenmarkLaboratoires TheaRecruitingOcular Hypertension | GlaucomaDenmark
-
CHA UniversitySamil Pharmaceutical Co., Ltd.CompletedOcular Hypertension | GlaucomaKorea, Republic of
-
Association for Innovation and Biomedical Research...European Vision Institute Clinical Research NetworkCompletedOcular Hypertension | GlaucomaUnited Kingdom, Switzerland, Belgium, Italy, Portugal, Austria