Safety and Efficacy Assessment of Monoprost® in Comparison With Lumigan® 0.01 % and Lumigan® 0.03% Unit Dose

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Laboratoires Thea
Sponsor:
Information provided by (Responsible Party):
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT02017327
First received: December 2, 2013
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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).


Condition Intervention Phase
Primary Open Angle Glaucoma
Ocular Hypertension
Drug: Monoprost
Drug: Lumigan 0.01%
Drug: Lumigan 0.03% Unit Dose
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:
  • safety with respect to the assessment of conjunctival hyperaemia in the Worse eye [ Time Frame: Day 84 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Response to treatment [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    The major secondary endpoint is response to treatment defined as a mean Intra Ocular Pressure ≤ 18 mm Hg and a decrease in MacMonnies scale from baseline of at least 1 point in the worse eye at the D84 visit.


Estimated Enrollment: 396
Study Start Date: December 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Monoprost
1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.
Drug: Monoprost
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 Name: Latanoprost 0.005%
Active Comparator: Lumigan 0.01%
1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.
Drug: Lumigan 0.01%
Lumigan® 0.01%: Bimatoprost eye drop solution is supplied in 3 ml multidose container.
Other Name: Bimatoprost 0.1mg/ml
Active Comparator: Lumigan 0.03% Unit Dose
1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.
Drug: Lumigan 0.03% Unit Dose
Lumigan® 0.03% Unit Dose: Bimatoprost eye drop solution is supplied in 0.4 ml single use low density polyethylene (LDPE) containers.
Other Name: Bimatoprost 0.3mg/ML

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female aged ≥18 years old.
  • Written informed consent.
  • Association of the 3 following criteria:

    1. 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).
    2. Intra Ocular Pressure ≤ 18 mm Hg in both eyes.
    3. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02017327

Locations
France
Laboratoires Théa Recruiting
Clermont ferrand, France, 63000
Contact: Lydia Bresson    04 73 98 95 07    l.bresson@laboratoires-thea.fr   
Principal Investigator: Christophe Baudouin, Professor         
Sponsors and Collaborators
Laboratoires Thea
Investigators
Principal Investigator: Christophe Baudouin, Professor Hopital des XV-XX
  More Information

No publications provided

Responsible Party: Laboratoires Thea
ClinicalTrials.gov Identifier: NCT02017327     History of Changes
Other Study ID Numbers: LT2345-PIV-02/13
Study First Received: December 2, 2013
Last Updated: December 16, 2013
Health Authority: France: Agance Nationale de Sécurité des Médicaments et des Produits de Santé
Espagne: Agencia Espanola de Medicamentos y Productos Sanitarios
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Switzerland: Swissmedic

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Latanoprost
Bimatoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014