In this study the effectiveness and safety of topical Forskolin (0.15%) will be compared with standard drug-topical Timolol (0.5%) in patients with ocular hypertension or open angle glaucoma.
- Conditions
- Health Condition 1: H401- Open-angle glaucoma
- Registration Number
- CTRI/2020/01/022887
- Lead Sponsor
- SamiSabinsa Group Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Newly diagnosed with ocular hypertension or open angle glaucoma.
2. Non-medicated IOP is equal to or greater than 22mmHg and less than 30mmHg in one or both eyes.
3. Patients currently on no topical IOP lowering medication.
4. At screening the intraocular pressure must be considered to be safe in such a way that should assure clinical stability of vision and the optic nerve throughout the trial.
5. Snellen visual acuity must be 6/12 or better in both eyes.
6.Willingness to comply with the investigators and protocol instruction.
7. > 18 years of age (male and female adult subjects).
8.Patient signature on the informed consent document [each patient should be given ample time to read (or have read to them) the consent form, ask any questions they may have regarding the trial and have a clear understanding of the trial and the procedures involved prior to the signing of the consent form.
1.Any abnormality preventing reliable Applanation Tonometry.
2.Diagnosed with advanced stage of glaucoma
3.Any opacity or patient uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber.
4.A person having only one eye (anopthalmia) & sight in a single eye.
5.Progressive retinal or optic nerve disease apart from glaucoma.
6.Previous glaucoma filtering surgery
7.Subjects who have undergone Argon Laser Trabeculoplasty (ALT) or Selective Laser Trabeculoplasty (SLT) or laser iridotomy
8.Any concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
9.Any clinically significant, serious, or severe medical or psychiatric condition that in the investigatorââ?¬•s opinion may result in poor compliance with the study protocol and / or may increase the likelihood of any adverse event related to any of the study medications.
10.Any anticipated change during active treatment phase of this study in systemic hypertensive therapy during the trial which might include adjustments to oral �Ÿ - adrenergic blockers, ï?¡-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers.
11.History of ocular herpes simplex, cystoids macular edema or uveitis.
12.Use of chronic corticosteroids by any route.
13.According to the investigatorââ?¬•s best judgment, risk of visual field or visual acuity worsening as a consequence of participation in the trial.
14.Females of childbearing potential not using reliable means of birth control.
15.Pregnant or lactating females.
16.Inability to understand the trial procedures, and thus inability to give informed consent.
17.Any history of allergic hypersensitivity or poor tolerance to any components of the preparations used in this trial.
18.Participation (or current participation) in any investigational drug or device trial within the previous 30 days prior to screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Applanation Tonometry (Goldmann / Perkins) reading at 08:00 (0:00), 10:00 (02:00), 12:00(04:00), 16:00 (08:00) hours. <br/ ><br>2.Snellen Visual acuity <br/ ><br>3.Slit lamp biomicroscopy <br/ ><br>4.Humphrey Visual field examination(24-2) <br/ ><br>5.Dilated fundus examinationTimepoint: 1.Applanation Tonometry (Goldmann / Perkins) reading at 08:00 (0:00), 10:00 (02:00), 12:00(04:00), 16:00 (08:00) hours (Day0,Day15, <br/ ><br>Day30,Day45,Day60, Day75 & Day90). <br/ ><br>2.Snellen Visual acuity (Screening,Day0,Day30,Day60 & Day90) <br/ ><br>3.Slit lamp biomicroscopy (Screening,Day0,Day30,Day60 & Day90) <br/ ><br>4.Humphrey Visual fieldexamination(24-2)(Screening & Day90) <br/ ><br>5.Dilated fundus examination)(Screening & Day90).
- Secondary Outcome Measures
Name Time Method 1.Gonioscopy <br/ ><br>2.Pachymetry <br/ ><br>3.Adverse eventsTimepoint: 1.Gonioscopy (Day0 & Day90) <br/ ><br>2.Pachymetry (Day0 & Day90) <br/ ><br>3.Adverse events (Day0,Day15, <br/ ><br>Day30,Day45,Day60, Day75, Day90 & telephonic follow up at least 15 days from the last <br/ ><br>visit).