Health Condition 1: null- chronic open angle glaucoma or ocular hypertension
Conditions
Interventions
Intervention1: Tobramycin 0.3% and Dexamethasone 0.1% Ophthalmic Suspension: Single dose
Intervention2: Brinzolamide 1% ophthalmic suspension: 1 drop in each eye three times a day, up to 6 weeks.
Inte
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Written, signed, dated and ethics committee approved informed consent obtained from subjects and/or legally acceptable representative, along with the audio-video recording of the process, before performing any screening procedures 2.Male or non-pregnant females of age 18 to 65 years [both inclusive] with chronic open angle glaucoma or ocular hypertension in both eyes on stable ocular hypotensive treatment regimen 3.Subject requires treatment of both eyes and is able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period 4.Adequate wash-out period prior to baseline of any ocular hypotensive medication (see Table 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 1. 5.Baseline (Day 0/hour 0) IOP >= 22 mm Hg and 6.Baseline best corrected visual acuity equivalent to 20/200 or better in each eye.
Exclusion criteria
Exclusion criteria: 1.Females who are pregnant, breast feeding, or planning a pregnancy. 2.Females of childbearing potential who do not agree to utilize an adequate form of contraception. 3.Current or past history of severe hepatic or renal impairment. 4.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. 5.Current corneal abnormalities that would prevent accurate IOP readings with the Goldmann applanation tonometer. 6.Functionally significant visual field loss. 7.Contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity to any component of brinzolamide or sulfonamide therapy. 8.Use of intraocular corticosteroid implant at any time prior to baseline. 9.Use of contact lens within one week prior to baseline. 10.Use of: a) topical ophthalmic corticosteroid, or b) topical corticosteroid within two weeks prior to baseline. 11.Use of: a) systemic corticosteroid or b) high-dose salicylate therapy within one month prior to baseline. 12.Use of intravitreal or subtenon injection of ophthalmic corticosteroid within six months prior to baseline. 13.Performance of any other intraocular surgery (e.g., cataract surgery) within six months prior to baseline 14.Performance of refractive surgery, filtering surgery or laser surgery for IOP reduction within twelve months prior to baseline 15.History of alcohol, chemical or drug abuse or dependence as per DSM IV criteria 16.Serologic positivity for the Hepatitis B virus (HBV), Hepatitis C virus (HCV) or Human Immunodeficiency Virus (HIV) 17.Current active malignancy or history of malignancy within the past five years 18.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean difference in intraocular pressure (IOP) of both eyes between the Cipla Brinzolamide TID and Azopt® TID groups at four time points.Timepoint: At approximately 8:00 am (hour 0; before the morning dose) and 10:00 am (hour 2) at the Day 14 (week 2) and Day 42 (week 6) visits. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in the IOP at week 4 compared to baselineTimepoint: 4 weeks;Subjectâ??s overall satisfaction with treatmentTimepoint: 6 weeks;The mean difference in IOP of both eyes between Cipla Brinzolamide BID group Vs Azopt TID group at four time points.Timepoint: At approximately 8:00 am (hour 0; before the morning dose) and 10:00 am (hour 2) at the Day 14 (week 2) and Day 42 (week 6) visits.;The mean difference in IOP of both eyes between Cipla Brinzolamide TID group Vs Cipla Brinzolamide BID group at four time points.Timepoint: At approximately 8:00 am (hour 0; before the morning dose) and 10:00 am (hour 2) at the Day 14 (week 2) and Day 42 (week 6) visits. | — |
Countries
India
Contacts
Public ContactDr Sachin Naik
Cipla Ltd., India
Outcome results
None listed