Efficacy and Safety of SPARC0912 and Reference0912 in Open Angle Glaucoma or Ocular Hypertension
Condition: Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: SPARC0912; Reference0912
Intervention description: Eye drops, once daily, 12 weeks; Eye drops, once daily, 12 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 578.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: glaucoma latanoprost

Summary:

      A single-blind , 12-week, parallel group clinical study is planned to evaluate the efficacy
      and safety of SPARC0912 and Reference0912. SPARC0912 is an experimental drug having similar
      active ingredient but containing a different preservative as that in Reference0912. Patients
      with open angle glaucoma or ocular hypertension will be enrolled and randomly assigned to
      receive either product. One drop will be instilled to the study eye nightly at 8:00 PM.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women aged ≥ 18 years.

          -  Diagnosis of ocular hypertension (OHT) or primary open angle glaucoma (POAG).

          -  Unmedicated IOP ≥ 22 mmHg in one or both eyes.

          -  Given informed consent.

          -  Women of child bearing potential practicing an acceptable method of birth control with
             a negative urine pregnancy test.

        Exclusion Criteria:

          -  Known lack of ocular hypotensive response to topical ophthalmic, prostaglandin analogs
             (in the opinion of the investigator).

          -  Intraocular conventional surgery or laser surgery within the past six months.

          -  Refractive surgery in study eye (e.g., radial keratotomy, PRK, LASIK, etc.) within the
             past 3 months.

          -  Angle closure glaucoma or a history of acute angle closure treated with a peripheral
             iridotomy.

          -  Ocular trauma within the past 3 months.

          -  Progressive retinal or optic nerve disease apart from glaucoma.

          -  Concurrent infectious/non infectious conjunctivitis, keratitis, or uveitis in either
             eye.

          -  Any abnormality preventing stable applanation tonometry.

          -  Use of contact lens for the duration of the study.

          -  Any opacity or subject uncooperativeness that restricts adequate examination of the
             ocular fundus or anterior chamber.

          -  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 medications is not
             judged safe.

          -  Clinically significant systemic disease which might interfere with the study.

          -  History of non-compliance to medical regimens or unwilling to comply with the study
             protocol.

          -  Participation in another clinical study within the last thirty (30) days.