CTRI/2019/04/018738Not yet recruitingPhase 4
Evaluation of efficacy and safety of bimatoprost 0.01% (Careprost) preservative-free (PF) ophthalmic solution in comparison toconventional bimatoprost 0.01% (Lumigan) ophthalmic solution for glaucoma or ocular hypertension in Indian population - ET1901001
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Sun Pharma Laboratories Ltd
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Pms
Eligibility Criteria
Inclusion Criteria
- •1) Men and women aged >=18 years.
- •2) Diagnosis of ocular hypertension (OHT) or primary open angle glaucoma (POAG) in one eye or both eyes
- •3) Unmedicated IOP >= 22 -30 mmHg in one or both eyes with no more than 5 mmHg inter-eye difference
- •4) Willing to give informed consent.
- •5) Best corrected visual acuity equivalent to a Snellen score of 20/100 or better in each eye.
- •6) For ongoing medication below is acceptable minimum washout period.
- •04 days for parasympathomimetic and topical or systemic carbonic anhydrase inhibitors,
- •02 weeks for sympathomimetics and α-agonists
- •04 weeks for β-adrenergic blocking agents, combination products and prostaglandin agonists
- •7) Women of child bearing potential practicing an acceptable method of birth control as judged by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), oral or long acting injected contraceptives] from at least 2 months prior to study entry and through the duration of the study; or be postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject); or with a negative urine pregnancy test.
Exclusion Criteria
- •1) History of allergic hypersensitivity or poor tolerance to any of the components of the preparations to be used in this study.
- •2) Known lack of ocular hypotensive response to topical ophthalmic, prostaglandin analogs (in the opinion of the investigator).
- •3) Intraocular conventional surgery or laser surgery within six months of the study.
- •4) Use of contact lenses during the study;
- •5) Use of systemic corticosteroids within 21 days before any study visit;
- •6) Use of ophthalmic corticosteroids within 2 months or during the study;
- •7) History of inadequate IOP control on bimatoprost monotherapy;
- •8) Any clinical ocular surface ï¬?ndings at baseline such as trace or greater hyperaemia or irritation.
- •9) Refractive surgery in the study eye (e.g., radial keratotomy, PRK, LASIK, etc.) within the past 3 months.
- •10) Angle closure glaucoma or a history of acute angle closure treated with a peripheral iridotomy.
- •11) Ocular trauma within the past 3 months.
- •12) Progressive retinal or optic nerve disease apart from glaucoma or a torn posterior lens or having had a risk for macular edema.
- •13) Concurrent infectious/non-infectious conjunctivitis, keratitis, or uveitis in either eye.
- •14) Other than ocular hypotensive drugs, which must be washed out according to the provided schedule, ocular medication of any kind (with the exception of lubricating drops for dry eye) within 30 days of baseline.
- •15) Any abnormality preventing stable applanation tonometry.
- •16) Clinically significant ocular disease (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca), which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive drugs, is not judged safe.
- •17) Clinically significant systemic disease, which might interfere with the study.
- •18) History of non-compliance to medical regimens or unwilling to comply with the study protocol.
- •19) Patients having uncontrolled hypertension.
- •20) Participation in another clinical study within thirty (30) days.
- •21) Changes in systemic medication within 30 days prior to screening that could have a substantial impact on IOP, or anticipated changes during the study.
- •22) Patients who are pregnant, nursing a child or who are not willing to use acceptable methods of contraception during the study.
Investigators
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