192024-054: LUMIGAN® 0.1 mg/mL compared with LUMIGAN® 0.3 mg/mL
Research type
Research Study
Full title
A 2-year, multicenter, double-masked, randomized, parallel study of the safety of LUMIGAN® 0.1 mg/mL compared with LUMIGAN® 0.3 mg/mL in patients with glaucoma or ocular hypertension
IRAS ID
72307
Contact name
Kin Sheng Lim
Sponsor organisation
Allergan LTD
Eudract number
2010-023917-68
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
Research summary
PurposeThis 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.<table style="border-right: windowtext 1px solid; border-top: windowtext 1px solid; border-left: windowtext 1px solid; width: 95.08%; border-bottom: windowtext 1px solid" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="border-right: windowtext 1px solid; padding-right: 3.75pt; border-top: windowtext 1px solid; padding-left: 3.75pt; padding-bottom: 3.75pt; border-left: windowtext 1px solid; width: 39.04%; padding-top: 3.75pt; border-bottom: windowtext 1px solid"> <p style="text-align: center"><a title="Help on Conditions field" href="http://clinicaltrials.gov/ct2/help/conditions_desc">windowtext">Condition</a> </td> <td style="border-right: windowtext 1px solid; padding-right: 3.75pt; border-top: windowtext 1px solid; padding-left: 3.75pt; padding-bottom: 3.75pt; border-left: windowtext 1px solid; padding-top: 3.75pt; border-bottom: windowtext 1px solid"> <p style="text-align: center"><a title="Help on Interventions field" href="http://clinicaltrials.gov/ct2/help/interventions_desc">windowtext">Intervention</a> </td> <td style="border-right: windowtext 1px solid; padding-right: 3.75pt; border-top: windowtext 1px solid; padding-left: 3.75pt; padding-bottom: 3.75pt; border-left: windowtext 1px solid; padding-top: 3.75pt; border-bottom: windowtext 1px solid"> <p style="text-align: center"><a title="Help on Phase field" href="http://clinicaltrials.gov/ct2/help/phase_desc">windowtext">Phase</a> </td> </tr> <tr> <td style="border-right: windowtext 1px solid; padding-right: 3.75pt; border-top: windowtext 1px solid; padding-left: 3.75pt; padding-bottom: 3.75pt; border-left: windowtext 1px solid; width: 39.04%; padding-top: 3.75pt; border-bottom: windowtext 1px solid"> GlaucomaOcular Hypertension </td> <td style="border-right: windowtext 1px solid; padding-right: 3.75pt; border-top: windowtext 1px solid; padding-left: 3.75pt; padding-bottom: 3.75pt; border-left: windowtext 1px solid; padding-top: 3.75pt; border-bottom: windowtext 1px solid"> Drug: bimatoprost 0.01% ophthalmic solutionDrug: bimatoprost 0.03% ophthalmic solution </td> <td style="border-right: windowtext 1px solid; padding-right: 3.75pt; border-top: windowtext 1px solid; padding-left: 3.75pt; padding-bottom: 3.75pt; border-left: windowtext 1px solid; padding-top: 3.75pt; border-bottom: windowtext 1px solid"> Phase IV <table cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-right: 0cm; padding-left: 0cm; padding-bottom: 0cm; padding-top: 0cm"> Study Type: </td> <td style="padding-right: 0cm; padding-left: 12pt; padding-bottom: 0cm; padding-top: 0cm"> Interventional </td> </tr> <tr> <td style="padding-right: 0cm; padding-left: 0cm; padding-bottom: 0cm; padding-top: 0cm"></td> <td style="padding-right: 0cm; padding-left: 12pt; padding-bottom: 0cm; padding-top: 0cm">Primary Outcome Measures: Percentage of Patients Reporting One or More Treatment-Related Ocular Surface Adverse Events [TimeFrame:Month 24] [Designatedassafetyissue:No]Secondary Outcome Measures: Percentage of Patients Reporting One or More Treatment-Related Ocular Surface Adverse Events excluding "Conjunctival Hyperemia" [TimeFrame:Month 24] [Designatedassafetyissue:No]Timelines:Estimated Enrollment: 784Study Start Date April 2011Estimated Study Completion Date: August 2015Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)<p style="text-align: center"><table style="border-right: windowtext 1px solid; border-top: windowtext 1px solid; border-left: windowtext 1px solid; width: 100%; border-bottom: windowtext 1px solid" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="border-right: windowtext 1px solid; padding-right: 3.75pt; border-top: windowtext 1px solid; padding-left: 3.75pt; padding-bottom: 3.75pt; border-left: windowtext 1px solid; width: 38.08%; padding-top: 3.75pt; border-bottom: windowtext 1px solid"> <p style="text-align: center"><a title="Help on Arm Group field" href="http://clinicaltrials.gov/ct2/help/arm_group_desc">windowtext">Arms </a> </td> <td style="border-right: windowtext 1px solid; padding-right: 3.75pt; border-top: windowtext 1px solid; padding-left: 3.75pt; padding-bottom: 3.75pt; border-left: windowtext 1px solid; width: 61.92%; padding-top: 3.75pt; border-bottom: windowtext 1px solid"> <p style="text-align: center"><a title="Help on Interventions field" href="http://clinicaltrials.gov/ct2/help/interventions_desc">windowtext">Assigned Interventions </a> </td> </tr> <tr> <td style="border-right: windowtext 1px solid; padding-right: 3.75pt; border-top: windowtext 1px solid; padding-left: 3.75pt; padding-bottom: 3.75pt; border-left: windowtext 1px solid; width: 38.08%; padding-top: 3.75pt; border-bottom: windowtext 1px solid"> 1: Active Comparator bimatoprost 0.01% ophthalmic solution Intervention: Drug: bimatoprost 0.01% ophthalmic solution </td> <td style="border-right: windowtext 1px solid; padding-right: 3.75pt; border-top: windowtext 1px solid; padding-left: 3.75pt; padding-bottom: 3.75pt; border-left: windowtext 1px solid; width: 61.92%; padding-top: 3.75pt; border-bottom: windowtext 1px solid"> Drug: 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. Other Names: ú LUMIGAN© 0.01% ú LUMIGAN 0.1 mg/ml </td> </tr> <tr> <td style="border-right: windowtext 1px solid; padding-right: 3.75pt; border-top: windowtext 1px solid; padding-left: 3.75pt; padding-bottom: 3.75pt; border-left: windowtext 1px solid; width: 38.08%; padding-top: 3.75pt; border-bottom: windowtext 1px solid"> 2: Active Comparator bimatoprost 0.03% ophthalmic solution Intervention: Drug: bimatoprost 0.03% ophthalmic solution </td> <td style="border-right: windowtext 1px solid; padding-right: 3.75pt; border-top: windowtext 1px solid; padding-left: 3.75pt; padding-bottom: 3.75pt; border-left: windowtext 1px solid; width: 61.92%; padding-top: 3.75pt; border-bottom: windowtext 1px solid"> Drug: 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 Other Names: ú LUMIGAN© 0.03% ú LUMIGAN 0.3 mg/ml Eligibility<table cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-right: 0cm; padding-left: 0cm; padding-bottom: 0cm; padding-top: 0cm"> Ages Eligible for Study: </td> <td style="padding-right: 0cm; padding-left: 12pt; padding-bottom: 0cm; padding-top: 0cm"> 18 Years and older </td> </tr> <tr> <td style="padding-right: 0cm; padding-left: 0cm; padding-bottom: 0cm; padding-top: 0cm"> Genders Eligible for Study: </td> <td style="padding-right: 0cm; padding-left: 12pt; padding-bottom: 0cm; padding-top: 0cm"> Both </td> </tr> <tr> <td style="padding-right: 0cm; padding-left: 0cm; padding-bottom: 0cm; padding-top: 0cm"> Accepts Healthy Volunteers: </td> <td style="padding-right: 0cm; padding-left: 12pt; padding-bottom: 0cm; padding-top: 0cm"> No Criteria<span style="text-decoration:underline;">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 <span style="text-decoration:underline;">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
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
11/EM/0074
Date of REC Opinion
17 May 2011
REC opinion
Further Information Favourable Opinion