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A Comparative Study of SPARC's SDP-133 Once Daily and Lumigan in Subjects With Open Angle Glaucoma or Ocular Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03927443
Recruitment Status : Withdrawn ([Sponsors decision])
First Posted : April 25, 2019
Last Update Posted : July 29, 2019
Information provided by (Responsible Party):
Sun Pharma Global FZE

Brief Summary:
To evaluate the efficacy of once daily dosing with SPARC's novel ophthalmic formulation of bimatoprost compared with Lumigan 0.01% in subjects with open-angle glaucoma or ocular hypertension.

Condition or disease Intervention/treatment Phase
Open Angle Glaucoma Ocular Hypertension Drug: SDP-133 Drug: Lumigan Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Evaluator -Masked, Randomized, Parallel Group, Active Controlled, Comparative Study of SPARC's SDP-133 Once Daily Compared With Lumigan ® 0.01% (Bimatoprost Ophthalmic Solution) in Subjects With Open Angle Glaucoma or Ocular Hypertension
Actual Study Start Date : June 10, 2019
Actual Primary Completion Date : July 8, 2019
Actual Study Completion Date : July 8, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Bimatoprost

Arm Intervention/treatment
Experimental: Test Drug: SDP-133
one drop

Active Comparator: Reference Drug: Lumigan
one drop

Primary Outcome Measures :
  1. Mean Intra-ocular pressure (study eye) [ Time Frame: Week 12. ]

Secondary Outcome Measures :
  1. Time-matched change from baseline mean Intra-ocular pressure (study eye) [ Time Frame: Week 12 ]
  2. Time-matched percent change in Intra-ocular pressure (study eye) [ Time Frame: Week 12 ]

Other Outcome Measures:
  1. Adverse events [ Time Frame: Week 13 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Be male or female, of 18 years of age or older
  2. Provide signed and dated informed consent in accordance with good clinical practice (GCP) and local legislation prior to any study procedure.
  3. Have open-angle glaucoma, (with or without pseudo exfoliation, pigment dispersion component) or ocular hypertension in both eyes and likely to be controlled on monotherapy.
  4. Females of childbearing potential must not be pregnant or lactating (as confirmed by a negative urine pregnancy test Women of childbearing potential must agree to the use of a reliable method of contraception (e.g., total abstinence, intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], oral, transdermal, injected or implanted non- or hormonal contraceptive), throughout the study. A sterile sexual partner is not considered an adequate form of birth control. Subjects on hormonal contraceptives must have been on the same hormonal contraceptive for at least one month before the Screening and continue throughout the duration of the study. A female is considered of childbearing potential if she has had her first menses and she is either

    1. not postmenopausal for at least 12 consecutive months prior to enrollment;(Visit 1) or
    2. not surgically sterilized by bilateral tubal ligation, or bilateral oophorectomy, or hysterectomy
  5. Male subjects with partners of childbearing potential who are not using birth control as described above must use a barrier method of contraception (eg. Condom) if not surgically sterile (ie, vasectomy).
  6. Be able and willing to follow study instructions and complete all required visits.

Exclusion Criteria:

  1. In the opinion of the investigator have uncontrolled or unstable systemic disease (eg, diabetes) which might interfere with the study. Subjects with a history of cancer or requiring cancer treatment within the past 5 years. Basal Cell and its treatment are allowed.
  2. Current or history of subjects with depression, cerebral or active coronary insufficiency or orthostatic hypotension.
  3. (If female of childbearing potential) Be pregnant, nursing, or planning a pregnancy from study entry and through the duration of the study.
  4. In the opinion of the investigator the subject has clinically relevant, abnormally low or high blood pressure or pulse rate.
  5. Have any known allergy or sensitivity to the study medications or their components.
  6. Have any contraindications to bimatoprost therapy.
  7. Be enrolled in an investigational drug or device study or have participated in such a study within 30 days prior to Visit 1.
  8. Subject who may be involved in any aspect of the trial conduct, may not be an investigator, sub-investigator, or other site staff , or related to any site staff.
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Responsible Party: Sun Pharma Global FZE Identifier: NCT03927443    
Other Study ID Numbers: CLR_17_21
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Antihypertensive Agents