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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

NCT ID: NCT03927443

Last Updated: 2021-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-10

Study Completion Date

2019-07-08

Brief Summary

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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

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Conditions

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Open Angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Test

Group Type EXPERIMENTAL

SDP-133

Intervention Type DRUG

one drop

Reference

Group Type ACTIVE_COMPARATOR

Lumigan

Intervention Type DRUG

one drop

Interventions

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SDP-133

one drop

Intervention Type DRUG

Lumigan

one drop

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Pharmaceutical Industries Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Countries

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United States

Other Identifiers

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CLR_17_21

Identifier Type: -

Identifier Source: org_study_id