Safety and efficacy of Brinzolamide and Timolol eye drops to decrease intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension for whom single drug therapy provides insufficient for intraocular pressure reduction

Phase 4

Not yet recruiting

• Conditions: Diseases of the eye and adnexa,

• Registration Number: CTRI/2023/05/052720
• Lead Sponsor: Sun Pharma Laboratories Limited (SPLL)

Brief Summary

This is a Phase 4, singlearm, multicenter, open label study. The study will be conducted atapproximately 10-15 number of centers in India, having qualified Investigators.The study will be initiated only after the receipt of regulatory and ethicscommittee (EC) approval. After obtaining the informed consent, patientswill be screened by undergoing various assessments as mentioned in Schedule ofAssessment. After confirming the eligibility, test product Brinzolamide andTimolol Ophthalmic Suspension (1% w/v + 0.5% w/v) will be instilled into theaffected eye twice daily. After 12 weeks of treatment period, the end of study visitwill be conducted. During the study, assessments will be performed as mentionedin Schedule of Assessment.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-25
• Last Update Posted: 2023-06-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

1.Patients of either gender aged ≥ 18 years who are willing to provide written informed consent 2.Patients diagnosed with Primary Open–angle glaucoma or Ocular hypertension 3.Patients who are on mono-therapy of either carbonic anhydrase inhibitors (CAIs) or Beta-blockers or any other IOP-lowering therapy and not adequately controlled 4.Women of childbearing potential must have a negative urine pregnancy test before study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till at least two weeks after the last dose of the study medication 5.Male patients must have had a successful vasectomy or they and their female partners must meet the criteria above.

Exclusion Criteria

1.Patients with a history of allergic hypersensitivity to oral or topical Carbonic Anhydrase Inhibitors, Beta -blockers, sulfonamide drugs, or any components of these medications 2.Patients with acute or chronic conjunctivitis 3.Patients with reactive airway disease including bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease 4.Patients with known/history of sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block not controlled with pace-maker, overt cardiac failure, and cardiogenic shock 5.Patients with uncontrolled hypertension, dry eye syndrome, diabetic retinopathy, hyperchloraemic acidosis and uncontrolled diabetes 6.Patients with severe allergic rhinitis 7.Patients using intraocular corticosteroid implant 8.Patients using contact lenses within 1 week prior to enrolment 9.Patients using the following medications within two weeks prior to baseline of: 1) topical ophthalmic corticosteroid; 2) topical corticosteroid; 3) systemic corticosteroid, or 4) high dose salicylate therapy 10.Patients using intravitreal or subtenon injection of ophthalmic corticosteroid within 6 months prior to enrolment 11.Patients who are anticipated the need to initiate or modify medication that is known to affect IOP during the study period 12.Patients with severe renal impairment 13.Patients undergone intraocular surgery or laser surgery within the past 3 months 14.Patients currently using any systemic corticosteroid, or is having had therapy with any investigational agent within past 30 days 15.Patients with history of hematologic disorders other than mild anemia 16.Patients with history of non-compliance to medical regimens or those patients unwilling to comply with the study protocol 17.Patients with history of or currently having any of the severe/serious ocular condition or clinically significant medical conditions, such as cardiovascular, respiratory, renal, hepatic, endocrine, or gastrointestinal disease 18.Patients with history of or known case of HIV-AIDS, hepatitis B (Hep B), and hepatitis C (Hep C) 19.Participation in other studies involving investigational drugs or surgeries within the last 30 days or investigational biologics within the last 6 months prior to screening 20.Pregnant or lactating women and women of childbearing potential who are not using contraceptives 21.Investigator, study personnel, Sponsor representatives and their first degree relatives.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with treatment-emergent adverse events (TEAEs)	Throughout the study period

Secondary Outcome Measures

Name	Time	Method
Change from baseline in 2-hour post-dose IOP	Day 28, 56, and 84
Change from baseline in 0-hour pre-dose IOP	Day 28, 56, and 84

Trial Locations

Locations (22)

Aster Aadhar Hospital (Prerana Hospital Ltd.); 🇮🇳 Kolhapur, MAHARASHTRA, India

B.J. Medical college and Sassoon Hospital; 🇮🇳 Pune, MAHARASHTRA, India

D.Y. Patil Hospital; 🇮🇳 (Suburban), MAHARASHTRA, India

D.Y. Patil Medical College, Hospital & Research Centre; 🇮🇳 Pune, MAHARASHTRA, India

Dr. R.S.P.R Govt. Regional Eye Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Government Medical College & Government General Hospital (Old RIMSGGH); 🇮🇳 Srikakulam, ANDHRA PRADESH, India

GSVM Medical College; 🇮🇳 Nagar, UTTAR PRADESH, India

KAR Vision Eye Hospital; 🇮🇳 Khordha, ORISSA, India

Lifepoint Multispecialty Hospital; 🇮🇳 Pune, MAHARASHTRA, India

M&J Institute of Ophthalmology; 🇮🇳 Ahmadabad, GUJARAT, India

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Aster Aadhar Hospital (Prerana Hospital Ltd.)

🇮🇳Kolhapur, MAHARASHTRA, India

Dr Sujata Shailendra Navare

Principal investigator

9225068511

sujatanavare.aacr@gmail.com