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

NCT02017327 | Completed Phase 4 Results

• 2 other identifiers: LT2345-PIV-02/132013-001250-10
• Study Type: interventional
• Target: 379
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

  Day 84

Study Arms (3)

Monoprost

EXPERIMENTAL

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

Drug: Monoprost

Lumigan 0.01%

ACTIVE COMPARATOR

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

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.

Drug: Lumigan 0.03% Unit Dose

Interventions

Monoprost 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.

Also known as: Latanoprost 0.005%

Monoprost

Lumigan 0.01% DRUG

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

Also known as: Bimatoprost 0.1mg/ml

Lumigan 0.01%

Lumigan 0.03% Unit Dose DRUG

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

Also known as: Bimatoprost 0.3mg/ML

Lumigan 0.03% Unit Dose

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• \- 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).
• 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.
• 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.

Sponsors & Collaborators

• Laboratoires Thea: lead

Study Sites (1)

Laboratoires Théa

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Bimatoprost

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Director of medical operation
• Organization: Laboratoires Thea

J.auger@laboratoires-thea.fr

+473985089

Study Officials

• Christophe Baudouin, Professor

  Hopital des XV-XX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 20, 2013
• Study Start: December 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: April 2, 2020
• Results First Posted: April 2, 2020

Record last verified: 2020-02

Locations

FR (1)