Health Condition 1: null- Adults with ocular hypertension or mild open angle glaucoma Health Condition 2: H401- Open-angle glaucoma
Conditions
Interventions
Intervention1: Forskolin 0.15% aqueous solution: One drop of Forskolin 0.15% twice a day for 2 weeks
Control Intervention1: NIL: NIL
Sponsors
Sami labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male and female subjects greater than 18 years of age 2 Willingness to comply with the investigators and protocols instructions 3 Patients signature on the informed consent document 4 Have a clinical diagnosis of bilateral or unilateral mild primary open-angle and pigmentary or pseudo exfoliation glaucoma and ocular hypertension 5 Patients currently on no topical IOP lowering medication or patients with IOP controlled on one IOP lowering medication 6 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 7 Snellen visual acuity must be 0.4 or better in both eyes
Exclusion criteria
Exclusion criteria: 1 Any abnormality preventing reliable applanation tonometry 2 Any opacity or patient uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber 3 Any concurrent infectious or noninfectious conjunctivitis and keratitis or uveitis in either eye 4 Any history of allergic hypersensitivity or poor tolerance to any components of the preparations used in this trial 5 Females of childbearing potential not using reliable means of birth control 6 Pregnant or lactating females 7 Participation or current participation in any investigational drug or device trial within the previous 30 days prior to Screening 8 According to the investigators best judgment risk of visual field or visual acuity worsening as a consequence of participation in the trial 9 Inability to understand the trial procedures and thus inability to give informed consent 10 Any clinically significant serious or severe medical or psychiatric condition that in the investigators 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 11 Any anticipated change during active treatment phase of this study in systemic hypertensive therapy during the trial which might include adjustments to oral Ã? adrenergic blockers and alpha agonists and blockers and angiotensin converting enzyme inhibitors and calcium channel blockers 12 Progressive retinal or optic nerve disease apart from glaucoma 13 History of ocular herpes simplex, cystoids macular edema or uveitis 14 Use of chronic corticosteroids by any route 15 Previous glaucoma filtering surgery within the last 6 months 16 Subjects who have undergone Argon Laser Trabeculoplasty or Selective Laser Trabeculoplasty or laser iridotomy in the past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Snellen Visual acuity 2 Slit lamp biomicroscopy 3 Humphrey Visual field examination 24-2 4 Dilated fundus exam Timepoint: 1 Snellen Visual acuity(Screening,Baseline,Visit 2,Visit 3,Final Visit) 2 Slit lamp biomicroscopy(Screening,Baseline,Visit2,Visit3,Final Visit) 3 Humphrey Visual field examination 24-2(Screening,Final Visit) 4 Dilated fundus exam(Screening,Final Visit) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse EventsTimepoint: Visit 2, Visit 3 and Final Visit | — |
Countries
India
Contacts
Public ContactMr Suresh Karri
Sankara Nethralaya
Outcome results
None listed