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Comparison of Moxifloxacin plus Dexamethasone eye drops treatment for 6-weeks vs 2-weeks in patients with eye operation.

An open-label, comparative (6-weeks vs 2-weeks treatment) study on safety and efficacy of Moxifloxacin (0.5%) plus Dexamethasone (0.1%) Ophthalmic solution in post-cataract cases.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/02/017692
Enrollment
300
Registered
2019-02-15
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: H28- Cataract in diseases classified elsewhere

Interventions

Intervention1: Moxifloxacin (0.5%) plus Dexamethasone (0.1%): Dosage: Moxifloxacin (0.5%) plus Dexamethasone (0.1%). Frequency: 4 times per day. Duration: for 2 weeks post cataract surgery. Control In

Sponsors

Santhiram Medical College and General Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Male & Female patients aged above 18 years. 2) Diagnosed with cataract and undergo surgery for the same. 3) Initiated treatment with any one of the 3 patterns - Moxifloxacin (0.5%) + Dexamethasone (0.1%) for 6 weeks (OR) Moxifloxacin (0.5%) + Dexamethasone (0.1%) for 2 weeks (OR) Moxifloxacin (0.5%) + Prednisolone (1%) for 6 weeks. 4) Willing to give voluntary written informed consent.

Exclusion criteria

Exclusion criteria: 1) Aged below 18 years. 2) Not willing to participate. 3) Uncontrolled Glaucoma. 4) Intraocular hypertension. 5) Chronic or recurrent ocular inflammatory disease (i.e., iritis, scleritis, uveitis). 6) Intraocular inflammation or Ocular pain in the study eye prior to the surgery. 7) Traumatic cataract. 8) Complicated cataract. 9) Intraocular complications. 10) Patients with only one eye.

Design outcomes

Primary

MeasureTime frame
To evaluate the safety and efficacy of Moxifloxacin-Dexamethasone ophthalmic solution combination therapy for 2-weeks in post-cataract cases and its comparison with 6-weeks treatment group. Assessment includes examination of- i) Pain Scale, ii) Burning/stinging sensation, iii) Ocular itching, iv) Visual acuity, v) Intraocular pressure, vi) Infection, vii) Inflammation of Eyelid and conjunctiva; Cornea, viii) Ocular pain, ix) Anterior chamber inflammation.Timepoint: at 2 weeks and at 6 weeks.—

Secondary

MeasureTime frame
To evaluate the safety and efficacy of Moxifloxacin-Dexamethasone ophthalmic solution combination therapy for 2-weeks in post-cataract cases.Timepoint: at 2 weeks and at 6 weeks.—

Countries

India

Contacts

Public ContactDr K Latheef

Santhiram Medical College & General Hospital

klf.svims@gmail.com

Outcome results

None listed

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