A study of Netarsudil Ophthalmic Solution 0.02% w/v Vs Timolol Maleate Eye Drops 0.5% w/v in treatment of elevated intraocular pressure in patient with open angle glaucoma or ocular hypertension.
- Conditions
- Health Condition 1: H401- Open-angle glaucoma
- Registration Number
- CTRI/2020/01/022619
- Lead Sponsor
- Ajanta Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 197
Subjects meeting all of the following criteria will be recruited for the trial
1.Male and Female subjects between 18 â?? 65 years of age (both inclusive).
2.Newly diagnosed patients of primary open angle glaucoma / ocular hypertension in at least one eye confirmed by Goldmann applanation tonometry.
3.Subjects with IOP between 22 mmHg â?? 27 mmHg at the time of screening in any one eye. 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.
4.Visual acuity 6/60 or better.
5.Voluntary willingness of patient to give written informed consent prior to participation in trial.
Subjects will be excluded if ANY of the following conditions apply:
Ophthalmic:
1.Subjects with any severe or advanced cases of Glaucoma
2.Shaffer angle grade <= 2 in either eye, as measured by Gonioscopy
3.Subjects with pseudoexfoliation or pigment dispersion component glaucoma
4.Subjects who are blind or subjects who have a single eye.
5.Severe central visual field loss in either eye measured by Perimetry
6.Cup/disc ratio greater than 0.80
7.Current or history within three months prior to baseline of significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye.
8.Current corneal abnormalities that would prevent accurate IOP readings with the Goldmann applanation tonometer.
9.Subject who have history of any ocular surgery in either eye in past (e.g. peripheral iridotomy, glaucoma incisional or laser surgery, refractive surgery) or are planning to undergo any ocular surgery during study period
10.Subjects having central corneal thickness greater than 600 mm in either eye
11.History of clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy or retinal detachment.
12.Subjects using contact lenses.
13.Contraindication or hypersensitivity to any component of study medication
14.Subject having history of chronic use of any ocular medication
15.Subjects having local administration of corticosteroids injections in the eye
Others:
16.Use within one month prior to baseline of: 1) systemic corticosteroid or 2) high-dose salicylate therapy or 3) Oral carbonic anhydrase inhibitor
17.Females who are pregnant, breast feeding, or planning a pregnancy.
18.Females of childbearing potential who do not agree to utilize an adequate form of contraception
19.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.
20.Subjects with/history of Bronchial Asthma, bronchial hyper reactivity or severe COPD that would preclude the safe administration of a topical beta blocker.
21.Subjects on these listed medications will be excluded from the study: a) High-dose ( >1 gm daily) salicylate b) Topical as well as Oral β-Blockers c) alpha agonists and blockers d) ACE inhibitors and calcium channel blockers e) Systemic administration of corticosteroids or immunosuppressive agents.
22.Participation in any clinical study within 30 days prior to entry into the study.
23.Subject not willing to comply with the study protocol and does not provide written informed consent to participation
24.Subjects with Type 1 and uncontrolled Type 2 Diabetes Mellitus (i.e. defined as Glycosylated HbA1C Level >7%).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean Reduction in IOP at the end of 12 weeks of treatment as compared to baseline at 9.00 AM, 11.00 AM and 5.00 PMTimepoint: Day 0 and Day 84
- Secondary Outcome Measures
Name Time Method Mean Reduction in IOP at the end of 4 weeks of treatment as compared to baseline <br/ ><br>Mean Reduction in IOP at the end of 8 weeks of treatment as compared to baseline. <br/ ><br>The assessment of safety of Subjects (comparison of incidence of treatment emergent adverse event (TEAE)) and change in ophthalmogical parameters. <br/ ><br>The assessment of tolerability of Investigational Product will be based on incidence of AEs and SAEs and Changes in laboratory values.Timepoint: Day 0, Day 28 and Day 56