A clinical study to evaluate the efficacy and safety of Combination of Netarsudil and Latanoprost in Comparison with Latanoprost in Patients with Glaucoma or Eye Hypertension
Phase 3
Recruiting
- Conditions
- Open-angle glaucoma,
- Registration Number
- CTRI/2021/02/031337
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Brief Summary
This is a Phase III, double-blind, randomized, multicenter, activecontrolled, parallel-group, two arm comparative study. The study will beconducted at approximately 15-18 number of centers in India, having qualifiedInvestigators. The study will be initiated only after the receipt of regulatoryand ethics committee (EC) approval.
After obtaining the informed consent, patientswill be screened by undergoing various assessments as mentioned in Schedule ofAssessment and patients already using IOP lowering medication will undergominimum washout period as mentioned in the inclusion criteria. After confirmingthe eligibility on Day 1, patients will be randomized by allotting therandomization number. Day 1 IOP assessment will be considered as baselineassessment for the study. Patients will be randomized in 1:1 ratio in eitherFDC of Netarsudil (0.02%) + Latanoprost (0.005%) arm or Latanoprost (0.005%)arm. Patients will be taking the study drugs till week 12 (Treatment period). Duringthe study, assessments will be performed as per Schedule of Assessment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 234
Inclusion Criteria
- Subjects will be included in the study if they meet all of the following criteria: 1) Patients of either sex, aged 18 to 65 years (both inclusive) and ready to give written informed consent to participate in the study.
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- Diagnosis (new/old) of primary open angle glaucoma / ocular hypertension in at least one eye confirmed by Goldmann applanation tonometry.
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- IOP values a.
- Newly diagnosed: IOP > 20 mmHg and < 36 mmHg at 9 AM in at least one eye at screening and day 1 (randomization day) b.
- Old patients: Unmedicated (post-washout (refer note)) IOP > 20 mmHg and < 36 mmHg at 9 AM in at least one eye at day 1 (randomization day) For purposes of determining eligibility of subjects to be randomized, IOP number should not be rounded off.
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- Best corrected visual acuity +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/40 (6/12) or better Snellen visual acuity in each eye) 5) Women of childbearing potential must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till the last dose of the study medication (such contraception may include hormonal birth control e.g., combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or sexual abstinence) [Note: Woman with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal] 6) A female patient of non-childbearing potential such as (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal.
- [Note: Post-menopausal woman will be defined as: Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhea and be greater than 45 years of age] Note: Ocular Hypotensive Medication Washout Period Prostaglandin analogues- 4 weeks β-adrenoceptor antagonists- 4 weeks Adrenergic agonists (including α-agonists such as brimonidine and apraclonidine)- 2 weeks Muscarinic agonists (eg, pilocarpine), carbonic anhydrase inhibitors (topical or oral)- 5 days.
Exclusion Criteria
- Subject will be deemed ineligible to participate in the study if he/she fulfils any of the following criteria: Ophthalmic: 1) Clinically significant ocular disease (eg, corneal edema, uveitis, or severe keratoconjunctivitis sicca) which might interfere with interpretation of the study efficacy endpoints or with safety assessments, including subjects with glaucomatous damage based on field effect so severe that washout of ocular hypotensive medications for 1 month is not judged safe as it would put the subject at risk for further vision loss.
- (The Investigator will be encouraged to conduct interim visits (unscheduled visits) during the washout period for IOP measurements for individuals to whom a washout period may be a risk for further glaucomatous progression) 2) Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles (ie, Shaffer Grade 2 or less; extreme narrow angle with complete or partial closure).
- Note: Previous laser peripheral iridotomy is NOT acceptable 3) Use of more than two ocular hypotensive medications within 28 days of screening.
- Note: fixed dose combination medications, for the purpose of this exclusion criterion, count as one medication 4) Known hypersensitivity to any component of the investigational formulations or to Latanoprost 5) Previous glaucoma intraocular surgery, including SLT or ALT in either eye 6) Refractive surgery in either eye (eg, radial keratotomy, PRK, LASIK, corneal cross-linking) 7) Ocular trauma within six months prior to screening, or ocular surgery or non-refractive laser treatment within three months prior to screening 8) Recent or current evidence of ocular infection or inflammation in either eye.
- Current evidence of clinically significant blepharitis, conjunctivitis, keratitis, or a history of herpes simplex or zoster keratitis in either eye at screening 9) Use of ocular medication in either eye of any kind within 30 days of screening and throughout the study, with the exception of a) ocular hypotensive medications (which must be washed out according to the provided schedule), b) lid scrubs (which may be used prior to, but not after, screening), c) lubricating drops for dry eye (which may be used throughout the study), or d) non-steroid allergy drops (note: must not contain a vasoconstrictor) as prescribed by the Investigator.
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- Mean central corneal thickness greater than 580 μm at screening 11) Any abnormality preventing reliable applanation tonometry of either eye (eg, keratoconus) 12) Subjects who are blind or subjects who have a single eye 13) History of clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy or retinal detachment.
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- Subjects using contact lenses.
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- Subjects having local administration of corticosteroids injections in the eye Systemic: 16) Participation in any investigational study within 30 days prior to screening 17) Systemic medication that could have a substantial effect on IOP within 30 days prior to screening, or anticipated during the study, including any corticosteroid-containing drug regardless of route of administration 18) Subjects with history of CVS, Hepatic, Psychiatric, Cancer or Renal diseases which could be considered significant for the subject to be enrolled in the study 19) Subjects with Type 1 and uncontrolled Type 2 Diabetes Mellitus (i.e. HbA1c Level > 7%).
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- Patients with any clinically significant lab abnormalities/ condition which in the opinion of investigator would compromise the well-being of the patient or the conduct of the study, or prevent the patient from meeting or performing study requirements 21) Pregnant or lactating women 22) Patient with known alcohol or other substance abuse within last one year as per DSM -5 criteria.
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- Employee of the sponsor, investigator, or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees of sponsor or the investigator.
- In case both the eyes of a single subject are affected then the eye fulfilling the criteria will be considered for the evaluations.
- If both eyes are fulfilling the criteria, then the right eye will be considered for the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean Reduction in IOP at the end of week 12 as compared to baseline at 9.00 AM, 11.00 AM and 5.00 PM week 12
- Secondary Outcome Measures
Name Time Method Mean Reduction in IOP at the end of week 4 as compared to baseline at 9.00 AM, 11.00 AM and 5.00 PM week 4 Mean Reduction in IOP at the end of week 8 as compared to baseline at 9.00 AM, 11.00 AM and 5.00 PM week 8 Safety assessment includes Treatment Emergent Adverse Events (TEAEs) assessment during the study week 12
Trial Locations
- Locations (11)
AIIMS
🇮🇳Khordha, ORISSA, India
Aster Aadhar Hospital (Prerana Hospital Ltd)
🇮🇳Kolhapur, MAHARASHTRA, India
B. J. Govt. Medical College And Sassoon General Hospital
🇮🇳Pune, MAHARASHTRA, India
GSVM Medical College
🇮🇳Nagar, UTTAR PRADESH, India
M& J Institute of Ophthalmology
🇮🇳Ahmadabad, GUJARAT, India
Pallavi Hospital
🇮🇳Nagpur, MAHARASHTRA, India
PBMA’s H V Desai Eye Hospital
🇮🇳Pune, MAHARASHTRA, India
R.S.P.R Govt. Regional Eye Hospital
🇮🇳Visakhapatnam, ANDHRA PRADESH, India
Regional Institute of Ophthalmology
🇮🇳Kolkata, WEST BENGAL, India
Sankat Mochan Nethralaya & Dental Care
🇮🇳Varanasi, UTTAR PRADESH, India
Scroll for more (1 remaining)AIIMS🇮🇳Khordha, ORISSA, IndiaDr Sucheta ParijaPrincipal investigator9437044380suchetaparija@yahoo.com