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

This study is currently recruiting participants.
Verified March 2016 by Laboratoires Thea
Sponsor:
ClinicalTrials.gov Identifier:
NCT02017327
First Posted: December 20, 2013
Last Update Posted: March 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Laboratoires Thea
  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
Intervention Model: Parallel Assignment
Masking: Single (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 ]
    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 ]
    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: July 2016
Estimated Primary Completion Date: July 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Laboratoires Thea
ClinicalTrials.gov Identifier: NCT02017327     History of Changes
Other Study ID Numbers: LT2345-PIV-02/13
2013-001250-10 ( EudraCT Number )
First Submitted: December 2, 2013
First Posted: December 20, 2013
Last Update Posted: March 17, 2016
Last Verified: March 2016

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