Safety and Efficacy of ANJANA in immature uncomplicated cataract

Evaluation of Efficacy and Safety of ANJANA in patients suffering from immature uncomplicated cataract-An open label, single-center, single-arm, prospective, interventional clinical study. - AN

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/09/073945

Enrollment

Registered

2024-09-17

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-14

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

Conditions

Health Condition 1: H578- Other specified disorders of eye and adnexa

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patient willing to provide written informed consent 2.Premenopausal female of age 30 – 70 years 3.Subjects with immature (Asymptomatic or Symptomatic) and uncomplicated cataract not requiring surgery. 4.Subjects having cataract with possible grading on slit lamp bio microscopy according to Lenticular Opacity Classification System II. 5.Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the protocol requirements of the clinical study.

Exclusion criteria

Exclusion criteria: 1.Subjects with congenital cataract, mature and hyper mature cataract. 2.Subjects having any other ophthalmic condition like glaucoma, diabetic retinopathy, macular degeneration, retinitis pigmentosa which requires urgent and separate treatment. 3.Subjects with Uncontrolled Diabetes and Uncontrolled Hypertension. 4.Subjects taking Steroid treatment and or any kind of immunosuppressive therapy. 5.Subjects participating in any other clinical study or having participated in any other Study 3 months prior to screening in the present study. 6.Subjects who are in general sensitive to any eye drops. 7.A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period. 8.Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol.

Design outcomes

Primary

Measure	Time frame
Changes in lens evaluated on LOCS II in Slit lamp Test between subjects using ANJANA at visit 3 and visit 4 as compared to baseline visit. Changes in direct and indirect ophthalmoscopic examinations between subjects using ANJANA at visit 3 and visit 4 as compared to baseline visit.Timepoint: Baseline to EOS.	—

Secondary

Measure	Time frame
Comparative clinical assessment of symptoms related to cataract in visit 4 as compared to baseline visit. Assessment of other changes in eyes-related symptoms like itching, tiredness, irritation, burning, etc. if any. Global assessment for overall change by the subject & investigator at the end of 90 days of study treatment. Adverse events reported during the study. Serious adverse events were reported during the study. Overall tolerability evaluation at the end of the study.Timepoint: 90 days	—

Measure

Time frame

Comparative clinical assessment of symptoms related to cataract in visit 4 as compared to baseline visit. Assessment of other changes in eyes-related symptoms like itching, tiredness, irritation, burning, etc. if any. Global assessment for overall change by the subject & investigator at the end of 90 days of study treatment. Adverse events reported during the study. Serious adverse events were reported during the study. Overall tolerability evaluation at the end of the study.Timepoint: 90 days

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Countries

India

Contacts

Public ContactProf Dr Pradip Kumar Panda

Sri Sri College of Ayurvedic Science and Research Hospital

pandapk9092@gmail.com08280252401

Outcome results