A Multicentric Randomized Double Blind Double Dummy Parallel Group Two Arm Comparative Phase III Clinical Study to Evaluate Efficacy Safety and Tolerability of Loteprednol Etabonate Ophthalmic Suspension 1% w/v of Ajanta Pharma Ltd
- Conditions
- Health Condition 1: H590- Disorders of the eye following cataract surgery
- Registration Number
- CTRI/2022/07/044211
- Lead Sponsor
- Ajanta Pharma Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Male or female subjects with 18 to 75 years of age (both inclusive).
2.Planned cataract surgery in at least one eye and underwent uncomplicated phacoemulsification under topical anesthesia.
3.Body Mass Index between 18.0 and 35.0 kg/m2.
4.Patient able to communicate effectively with the study personnel.
5.Should have undergone medical screening & fit for surgery.
6.Subject should be willing and able to comply with all treatment and follow- up/study procedures.
1.Suspected or history of hypersensitivity to either of the study medications or any of the ingredients of the formulation.
2.Have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the investigator feels might increase the risk to the subject or confound the results of the study.
3.Have an ocular hypertension �21 mm Hg, glaucoma or any glaucoma related incisional or laser surgery in the study eye.
4.Have had ocular surgery (inclusion laser surgery) in the study eye within 3 months or in the fellow eye within 2 weeks prior to Visit 1 (Screening).
5.Have a current diagnosis of cystoid macular edema in the study eye
6.Have any abnormality that prevents reliable Goldmann applanation tonometry in either eye.
7.Have iris atrophy in the operative eye.
8.Have lens pseudoexfoliation syndrome with glaucoma or zonular compromise in the study eye.
9.Be unable, for any reason to discontinue contact lens use in the study eye during the course of the study.
10.Have a history of chronic or recurrent inflammatory eye disease in the study eye (e.g. iritis, scleritis. Uveitis, iridocyclitis, herpes simplex infection).
11.Have proliferative diabetic retinopathy or moderate to severe non-proliferative diabetic retinopathy in the study eye.
12.Have any intraocular inflammation in either eye (cells or flare score greater than Grade 0atslit lamp examination) or ocular pain greater than Grade 1 in the study eye at Visit 1 (Screening).
13.Have a congenital ocular anomaly in either eye.
14.Have a presence of active external ocular disease: infection (bacterial, viral or fungal) or inflammation (including allergic) of the study eye.
15.Have used ocular therapy (either eye) with non-steroidal anti-inflammatory drugs (NSAIDs), mast cell stabilizers, antihistamines, or decongestants within 2 days prior to surgery or be expected to require any of these treatments during the 18 days following cataract surgery.
16.Be expected to require treatment with systemic NSAIDs, antihistamines or decongestants during the 18 days following cataract surgery with the exception of � 81 mg/day of acetylsaisylic acid.
17.Be expected to require treatment with any systemic, inhalation, nasal, or ocular (either eye) corticosteroids or glucocorticosteroids during the 18 days following cataract surgery or have used ocular immunosuppressant within 30 days prior to surgery.
18.Have participated in any drug or device clinical investigation within 30 days prior to participate into the study.
19.Any blood donation or significant loss of blood within 56 days of Visit 1
20.Any history of immunodeficiency disorder, positive HIV, hepatitis B, C, or evidence of acute active hepatitis A (anti-HAV IgM), or organ or bone marrow transplant.
21.Any significant illness that could interfere with study parameters
22.Known history of alcohol and/or drug abuse.
23.Unwilling to stop wearing contact lenses during the study.
24.Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
25.Females who are not ready to use acceptable contraceptive methods during the course of study.
26.Currently taking prohibited concomitant medications(s) listed and inability/unwillingness to discontinue t
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Proportion of Subjects With Complete Resolution of Anterior Chamber (AC) Cells at visit 5 [ Time Frame: postoperative Day 8] <br/ ><br>2.Proportion of Subjects With Grade 0 Pain in the Study Eye. [ Time Frame: 8 days ] <br/ ><br> <br/ ><br>Timepoint: Visit 5 (postoperative Day 8)
- Secondary Outcome Measures
Name Time Method 1.Proportion of study eyes with complete resolution of Anterior Chamber (AC) Flare at each visit and for each subjects final on treatment visit. <br/ ><br>2.Proportion of study eyes with Grade 0 pain at each visit and for each subject final on treatment visit. <br/ ><br>3.Proportion of subjects with Complete Resolution of Anterior Chamber (AC) cells at Visit 4, 5 and 6 [Time Frame: postoperative Day 3, 8 and 15] <br/ ><br>Timepoint: 1. Resolution of AC flare at each visit <br/ ><br>2. Grade 0 pan at each visit <br/ ><br>3. Resolution of AC cells at Visit 4, 5 and 6 (postoperative Day 3, 8 and 15)