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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Ocular Hypertension; Open Angle Glaucoma
• Intervention / Treatment: Drug: SDP-133; Drug: Lumigan

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Reference	Drug: Lumigan; one drop
Experimental: Test	Drug: SDP-133; one drop

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean Intra-ocular pressure (study eye)	Week 12.

Secondary Outcome Measures

Outcome Measure	Time Frame
Time-matched change from baseline mean Intra-ocular pressure (study eye)	Week 12
Time-matched percent change in Intra-ocular pressure (study eye)	Week 12

Other Outcome Measures

Outcome Measure	Time Frame
Adverse events	Week 13

Collaborators and Investigators

• Sponsor: Sun Pharmaceutical Industries Limited

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2019
• Primary Completion (Actual): July 8, 2019
• Study Completion (Actual): July 8, 2019

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: April 24, 2019
• First Posted (Actual): April 25, 2019

Study Record Updates

• Last Update Posted (Actual): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Antihypertensive Agents; Bimatoprost
• Other Study ID Numbers: CLR_17_21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No