Long-Term Safety of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

Phase 4

Completed

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: bimatoprost 0.01% ophthalmic solution; Drug: bimatoprost 0.03% ophthalmic solution

• Registration Number: NCT01298700
• Lead Sponsor: Allergan

Brief Summary

This study will evaluate the long-term safety of bimatoprost 0.01% ophthalmic solution compared with bimatoprost 0.03% ophthalmic solution in patients with glaucoma or ocular hypertension.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-16
• Study First Submitted QC: 2011-02-16
• Study First Posted: 2011-02-18
• Study Start: 2011-05-31
• Primary Completion: 2016-12-06
• Study Completion: 2016-12-06
• Status Verified: 2017-12
• Results First Submitted: 2018-01-02
• Results First Submitted QC: 2018-01-02
• Last Update Submitted: 2018-01-02
• Results First Posted: 2018-09-17
• Last Update Posted: 2018-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 806

Inclusion Criteria

• Ocular hypertension or glaucoma in each eye
• Requires intraocular pressure (IOP)-lowering therapy in both eyes
• Best corrected visual acuity of 20/100 or better in each eye

Exclusion Criteria

• Ocular seasonal allergies within 2 years
• Required chronic use of ocular medications during the study (intermittent use of artificial tears is allowed)
• Ocular surgery or laser within 3 months
• Anticipated wearing of contact lenses during the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bimatoprost 0.01% Ophthalmic Solution	bimatoprost 0.01% ophthalmic solution	One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
Bimatoprost 0.03% Ophthalmic Solution	bimatoprost 0.03% ophthalmic solution	One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events	24 Months	An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The percentage of participants with ocular (eye) surface AEs deemed related to treatment by the investigator are reported.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events Excluding "Conjunctival Hyperemia"	24 Months	An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The percentage of participants with ocular (eye) surface AEs deemed related to treatment by the investigator excluding AEs with the preferred term Conjunctival hyperemia are reported.

Trial Locations

Locations (50)

UZ Leuven; 🇧🇪 Leuven, Belgium

CHU Sart Tilman; 🇧🇪 Liege, Belgium

University Hospital Brno; 🇨🇿 Brno, Czechia

Eye Clinic; 🇨🇿 Frydstejn, Czechia

Centre Hospitalier Universitaire de Bordeaux; 🇫🇷 Bordeaux, France

Clinique Montcelli; 🇫🇷 Marseille, France

Universitat Augenklinik; 🇩🇪 Freiburg, Germany

Univ. des Saarlandes; 🇩🇪 Homburg Saar, Germany

Johannes Gutenberg Univ Mainz; 🇩🇪 Mainz, Germany

Thelen Private Practice; 🇩🇪 Műnster, Germany

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