â??PROSPECTIVE, OBSERVATIONAL STUDY TO OBSERVE THE EFFICACY AND SAFETY OF BRINZOLAMIDE 1% OPHTHALMIC SUSPENSION IN SUBJECTS WITH CHRONIC OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSIONâ??
- Conditions
- Health Condition 1: null- Chronic Open Angle Glaucoma and or Intra Ocular Hypertensive Patients
- Registration Number
- CTRI/2015/10/006266
- Lead Sponsor
- Dr Rajesh Parekh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
•Written, signed, dated and ethics committee approved informed consent obtained from subjects and/or legally acceptable representative, before performing any screening procedures
•Male and/or non-pregnant females of age 18 to 65 years [both inclusive] with chronic open angle glaucoma or ocular hypertension in both the eyes on stable ocular hypotensive treatment regimen
•Newly diagnosed or Subjects who require treatment of both the eyes and is able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period
•Adequate wash-out period prior to baseline of any ocular hypotensive medication (see Table No. 1). In order to minimize potential risk to patients due to IOP elevations during the washout period, investigator may choose to substitute a parasympathomimetic or carbonic anhydrase inhibitor in place of a sympathomimetic, alpha-agonist, beta-adrenergic blocking agent, or prostaglandin; however, all patients must have discontinued all ocular hypotensive medication for the minimum washout period provided in Table No. 1
•Baseline (hour 0) IOP >= 22 mm Hg and <= 34 mm Hg in each eye and any asymmetry of IOP between the eyes which is no greater than 5 mm Hg
•Baseline best corrected visual acuity equivalent to 20/200 or better in each eye
•Female who are pregnant, breast feeding or planning a pregnancy
•Female of childbearing potential who do not agree to utilize an adequate form of contraception
•Current or past history of severe hepatic or renal impairment
•Current or history of significant ocular disease within two months prior to baseline e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye
•Current corneal abnormalities that would prevent accurate IOP readings with the Goldmann applanation tonometer
•Functionally significant visual field loss
•Contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity to any component of brinzolamide or sulfonamide therapy
•Use of intraocular corticosteroid implant at any time prior to baseline
•Use of contact lens within one week prior to baseline
•Use of: a) topical ophthalmic corticosteroid or b) topical corticosteroid within two weeks prior to baseline
•Use of: a) systemic corticosteroid or b) high-dose salicylate therapy within one month prior to baseline
•Use of intravitreal or subtenon injection of ophthalmic corticosteroid within six months prior to baseline
•Performance of any other intraocular surgery (e.g., cataract surgery) within six months prior to baseline
•Performance of refractive surgery, filtering surgery or laser surgery for IOP reduction within twelve months prior to baseline
•History of alcohol, chemical or drug abuse or dependence as per DSM IV criteria
•Current active malignancy or history of malignancy within the past five years
•Any other clinically significant abnormal medical condition that in the Investigators judgement would put the patient at increased risk of illness or injury would interfere with study participation or would interfere with the evaluation or quality of the data
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Endpoints: <br/ ><br>â?¢The mean change intraocular pressure (IOP) of both the eyes at four time points, i.e., at approximately 08:00 AM (hour 0; before the morning dose) and 10:00 AM (hour 2) at enrolment and on day 14 +3 days (week 2) visits <br/ ><br>â?¢The mean change in the IOP at week 2 compared to baseline <br/ ><br>Timepoint: Primary Endpoints: <br/ ><br>â?¢The mean change intraocular pressure (IOP) of both the eyes at four time points, i.e., at approximately 08:00 AM (hour 0; before the morning dose) and 10:00 AM (hour 2) at enrolment and on day 14 +3 days (week 2) visits <br/ ><br>â?¢The mean change in the IOP at week 2 compared to baseline <br/ ><br>
- Secondary Outcome Measures
Name Time Method Subjectâ??s overall satisfaction with treatment <br/ ><br>Safety Endpoints <br/ ><br>Incidence and nature of adverse events <br/ ><br>Incidence of drug related adverse events <br/ ><br>Clinically significant changes in the vital signs, ocular and laboratory examination <br/ ><br>Timepoint: Subjectâ??s overall satisfaction with treatment <br/ ><br>Safety Endpoints <br/ ><br>Incidence and nature of adverse events <br/ ><br>Incidence of drug related adverse events <br/ ><br>Clinically significant changes in the vital signs, ocular and laboratory examination <br/ ><br>