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

NCT ID: NCT02017327

Last Updated: 2020-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 379 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2016-07-31

Brief 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.

The conjunctival hyperaemia will be scored using the MacMonnies photographic scale (0 to 5).

Conditions

Primary Open Angle Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Monoprost

1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.

Group Type: EXPERIMENTAL

Monoprost

Intervention Type: DRUG

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%

1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.

Group Type: ACTIVE_COMPARATOR

Lumigan 0.01%

Intervention Type: DRUG

Lumigan® 0.01%: Bimatoprost eye drop solution is supplied in 3 ml multidose container.

Lumigan 0.03% Unit Dose

1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.

Group Type: ACTIVE_COMPARATOR

Lumigan 0.03% Unit Dose

Intervention Type: DRUG

Lumigan® 0.03% Unit Dose: Bimatoprost eye drop solution is supplied in 0.4 ml single use low density polyethylene (LDPE) containers.

Interventions

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.

Intervention Type: DRUG

Lumigan 0.01%

Lumigan® 0.01%: Bimatoprost eye drop solution is supplied in 3 ml multidose container.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Latanoprost 0.005%; Bimatoprost 0.1mg/ml; Bimatoprost 0.3mg/ML

Eligibility 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.

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratoires Thea

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christophe Baudouin, Professor

Role: PRINCIPAL_INVESTIGATOR

Hopital des XV-XX

Locations

Laboratoires Théa

Clermont-Ferrand, , France

Countries

France

Other Identifiers

2013-001250-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LT2345-PIV-02/13

Identifier Type: -

Identifier Source: org_study_id