Evaluation of safety and effectiveness of Atropine ophthalmic solution in children with progressive Myopia

Phase 4

• Conditions: Health Condition 1: H521- Myopia

• Registration Number: CTRI/2023/01/049169
• Lead Sponsor: Sun Pharma Laboratory Limited ( SPLL)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Patients of either gender, aged 5 to 14 years (both inclusive) and ready to give written informed assent to participate in the study and written informed consent from parents of participating child

2) Patients with documented active myopia progression of at least spherical equivalent -0.50 D over the last 12 months as determined or suggested by refractive records or change in lens power

3) Patients with refractive error of spherical equivalent -2.00 D or worse in each eye as measured by cycloplegic autorefraction

4) Patients with a difference between non-cycloplegic subjective spherical refraction and cycloplegic subjective spherical refraction of not greater than -1.00 D

5) Patients with astigmatism of <= -1.50 D as measured by cycloplegic or non-cycloplegic autorefraction

6) Patients with distance vision correctable to logarithm of the minimum angle of resolution (logMAR) 0.2 or better in both eyes using Early Treatment Diabetic Retinopathy study chart (ETDRS) method

7) Patients with normal intraocular pressure of <= 21 mmHg

8) Patients with normal ocular health other than myopia in less than 06 months of screening

9) Patients willing and able to tolerate cycloplegia and mydriasis

10) Patients willing to come for regular follow-up for 12 months and follow study procedure

11) Female patients of age >= 12 years must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till the last dose of the study medication (such contraception may include hormonal birth control e.g., combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or total sexual abstinence)

Exclusion Criteria

1) Patients with ocular or systemic diseases which may affect vision or refractive error

2) Patients with any ocular condition wherein topical atropine is contraindicated (e.g. glaucoma or narrow angle glaucoma)

3) Patients with previous or current use of atropine

4) Patients with abnormal binocular function and stereopsis

5) Patients with amblyopia or manifest strabismus, including intermittent tropia

6) Patients with history or planning to undergo any ocular surgery

7) Patients who are on treatment of monoamine oxidase inhibitors (MAOI) or planning to take during study period

8) Patients who are hypersensitive to atropine, cyclopentolate, or any other cycloplegic agents including its components

9) Patients with any other conditions precluding adherence to the protocol including unwillingness to refrain from contact lens wear for the duration of the study

10) Participation in any investigational study within 30 days prior to screening

11) Pregnant or lactating female patients

12) Patients with any clinically significant lab abnormalities/ condition (e.g. cardiac or respiratory distress) which in the opinion of investigator would compromise the well-being of the patient or the conduct of the study, or prevent the patient from meeting or performing study requirements

13) Employee of the sponsor, investigator, or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees of sponsor or the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety: <br/ ><br>Proportion of participants with treatment emergent adverse events (TEAEs) (Photophobia and poor near visual acuity) in the study <br/ ><br>Timepoint: 12 Month

Secondary Outcome Measures

Name	Time	Method
A. Efficacy <br/ ><br>1. Spherical equivalent refraction (SER) determined by cycloplegic autorefraction from baseline <br/ ><br> <br/ ><br>[Time frame: Month 4, Month 8, Month 12] <br/ ><br>2. Axial length determined by A-scan ultrasonography from baseline [Time frame: Month 4, Month 8, Month 12] <br/ ><br> <br/ ><br> <br/ ><br>B. Safety <br/ ><br>1. Distance and near best corrected visual acuity (BCVA) from baseline [Time frame: Month 4, Month 8, Month 12] <br/ ><br>2. Pupil reactivity and diameter assessment (mesopic & photopic) from baseline <br/ ><br> <br/ ><br>[Time frame: Month 4, Month 8, Month 12] <br/ ><br>3. Any other TEAEs [Time frame: 12 months] <br/ ><br>Timepoint: 4 Month, 8 Month, 12 Month