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出境医 / 临床实验 / A Comparative Study of SPARC's SDP-133 Once Daily and Lumigan in Subjects With Open Angle Glaucoma or Ocular Hypertension

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

Study Description
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

Study Design
Layout table for study information
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
Arms and Interventions
Arm Intervention/treatment
Experimental: Test Drug: SDP-133
one drop
Active Comparator: Reference Drug: Lumigan
one drop
Outcome Measures
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 ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE April 22, 2019
First Posted Date  ICMJE April 25, 2019
Last Update Posted Date July 29, 2019
Actual Study Start Date  ICMJE June 10, 2019
Actual Primary Completion Date July 8, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2019) 		Mean Intra-ocular pressure (study eye) [ Time Frame: Week 12. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
  • Time-matched change from baseline mean Intra-ocular pressure (study eye) [ Time Frame: Week 12 ]
  • Time-matched percent change in Intra-ocular pressure (study eye) [ Time Frame: Week 12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 24, 2019) 		Adverse events [ Time Frame: Week 13 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Comparative Study of SPARC's SDP-133 Once Daily and Lumigan in Subjects With Open Angle Glaucoma or Ocular Hypertension
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Open Angle Glaucoma
  • Ocular Hypertension
Intervention  ICMJE
  • Drug: SDP-133
    one drop
  • Drug: Lumigan
    one drop
Study Arms  ICMJE
  • Experimental: Test
    Intervention: Drug: SDP-133
  • Active Comparator: Reference
    Intervention: Drug: Lumigan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 26, 2019) 		0
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2019) 		538
Actual Study Completion Date  ICMJE July 8, 2019
Actual Primary Completion Date July 8, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT03927443
Other Study ID Numbers  ICMJE CLR_17_21
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sun Pharma Global FZE
Study Sponsor  ICMJE Sun Pharma Global FZE
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sun Pharma Global FZE
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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