Ocular Hypertension Clinical Trial
— ConstellationOfficial title:
A Randomized, Single-Center, Open-Label, Crossover Study Comparing the Efficacy of BOL-303259-X Ophthalmic Solution With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension.
NCT number | NCT01707381 |
Other study ID # | 803 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | November 2012 |
Est. completion date | February 2014 |
Verified date | August 2018 |
Source | Bausch & Lomb Incorporated |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This clinical investigation is being performed to compare the effect of BOL-303259-X dosed once daily (QD) with timolol maleate 0.5% dosed twice daily (BID) in reducing intraocular pressure (IOP) measured over a 24-hour period in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).
Status | Completed |
Enrollment | 25 |
Est. completion date | February 2014 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Subjects must have a diagnosis of OAG or OHT in 1 or both eyes. - Subjects who are treatment-naïve must meet the following IOP requirements at Visit 1 (Screening), and pretreated subjects must meet the following IOP requirements at Visit 2 (Washout): Intraocular pressure = 22 mmHg in at least 1 eye and = 36 mmHg in both eyes. Exclusion Criteria: - Subjects who have been exposed to BOL-303259-X within 3 months prior to Visit 1 (Screening). - Subjects with a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the results of the study. - Subjects with an irregular daily sleep schedule. - Subjects who are unable to wear sleep monitoring device for 7 days prior to laboratory study. - Subjects with an anticipated need to initiate or modify medication (systemic or topical) that is known to affect IOP. - Subjects for whom concomitant use of medications may interact with the safety or efficacy of a nitric oxide. - Subjects with known hypersensitivity or contraindications to latanoprost or any of the ingredients in the study drugs. - Subjects who are expected to require treatment with ocular or systemic corticosteroids. - Subjects who are in need of any other topical or systemic treatment of OAG or OHT. - Subjects who are unable to discontinue contact lens use during and for 24 hours before the laboratory study. - Subjects with a central corneal thickness greater than 600 µm in either eye. - Subjects with any condition that prevents reliable applanationtonometry in either eye. - Subjects with advanced glaucoma and subjects with a cup/disc ratio greater than 0.8 or a history of split fixation, or a field loss threatening fixation in either eye. - Subjects with previous or active corneal disease. - Subjects with a history of severe dry eye. - Subjects with active optic disc hemorrhage. - Subjects with a history of central/branch retinal vein or artery occlusion. - Subjects with a history of macular edema. - Subjects with very narrow angles and subjects with angle closure, congenital, and secondary glaucoma, and subjects with history of angle closure in either eye. - Subjects with a diagnosis of a clinically significant or progressive retinal disease in either eye. - Subjects with any intraocular infection or inflammation within 3 months prior to Visit 1 (Screening). - Subjects with a history of ocular laser surgery within the 3 months prior to Visit 1 (Screening). - Subjects with a history of incisional ocular surgery or severe trauma within 3 months prior to Visit 1 (Screening). |
Country | Name | City | State |
---|---|---|---|
United States | University of California San Diego | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
Bausch & Lomb Incorporated |
United States,
Liu JHK, Slight JR, Vittitow JL, Scassellati Sforzolini B, Weinreb RN. Efficacy of Latanoprostene Bunod 0.024% Compared With Timolol 0.5% in Lowering Intraocular Pressure Over 24 Hours. Am J Ophthalmol. 2016 Sep;169:249-257. doi: 10.1016/j.ajo.2016.04.019 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 24 Hour IOP | Supine intraocular pressure (IOP) measured in the study eye following 4 weeks of treatment | after 4 weeks of treatment | |
Secondary | 24-hour Ocular Perfusion Pressure | Sitting Ocular Perfusion Pressure = 95/140 x mean arterial blood pressure - IOP; Supine Ocular Perfusion Pressure = 115/130 x mean arterial blood pressure - IOP; the nocturnal time frame encompassed measures taken at 10pm, 12am, 2am and 4 am; whereas the diurnal time frame encompassed measures taken at 6am, 8am, 10am, 12pm, 2pm, 4pm, 6pm, and 8pm. | after 4 weeks of treatment | |
Secondary | IOP Area Under the Curve Over 24 Hours | The Area Under the Curve(AUC) is the weighted average of IOP over all 24-hour IOP assessment times (2pm, 4pm, 6pm, 8pm, 10pm, 12am, 2am, 4am, 6am, 8am, 10am, 12pm). The AUC was calculated using the trapezoidal rule. | after 4 weeks of treatment |
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