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A clinical Trial in patients with Glaucoma. Clinical trial is to study efficacy, safety and tolerability of Tafluprost Ophthalmic solution in comparison to Latanoprost eye drop (reference product).

A Comparative, Randomized, Double Blind, Multicentric, Prospective Clinical Study to evaluate the efficacy, safety and tolerability of Tafluprost Ophthalmic solution 15 mcg/ml Vs. Latanoprost eye drops 0.005 % in patients with Glaucoma.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/001459
Enrollment
200
Registered
2010-10-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Glaucoma Health Condition 2: H409- Unspecified glaucoma

Interventions

Intervention1: Tafluprost Ophthalmic solution: One drop for 4 weeks Control Intervention1: Latanoprost Eye Drop: One drop for 4 weeks

Sponsors

Ajanta Pharma Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with diagnosis of glaucoma.

Exclusion criteria

Exclusion criteria: Pregnant or nursing females. Patients with exfoliation glaucoma and neovascular glaucoma. Patients with diabetic retinopathy. Patients with advanced visual field loss (MD <-15dB). Excessive myopia (<-6D). Any corneal abnormality or other condition preventing reliable applanation tonometry. Presence of any external disease and inflammation of the eye. History of refractive surgery. History of laser trabeculoplasty, filtering surgery, trabeculotomy, cataract surgery, and other intraocular surgery.

Design outcomes

Primary

MeasureTime frame
Blurred Vision, Halos around Lights, Pain and Redness of Eye.Timepoint: Day 1, week 1, week 2 and week 4.;Blurred Vision, Halos around Lights, Pain and Redness of Eye.Timepoint: Day 1, week 1, week 2 and week 4.

Secondary

MeasureTime frame
Overall global assessment of efficacy and tolerabilityTimepoint: Week 4

Countries

India

Contacts

Public ContactDr Shailesh Singh

Ajanta Pharma Ltd, Advent

shaileshs@ajantapharma.com022-66062112

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026