A Study to Evaluate the Efficacy and Safety of Pilocarpine Hydrochloride Ophthalmic Solution for the Treatment of Presbyopia.

Phase 3

Completed

Conditions: Presbyopia,

Registration Number: CTRI/2023/08/057127

Lead Sponsor: Entod Pharmaceuticals Limited

Brief Summary: After informed consent process,completion of all screening assessments and once all the inclusion/exclusioncriteria are met, the eligible subjects shall be enrolled into the study.Demographics, Medical and surgical history shall be recorded during screeningvisit. Details of concomitant medications and adverse events if any shall berecorded during each visit. Physical examination shall be done during screeningand each successive visit. Vital signs shall be measured on each visit. UPTshall be performed during screening visit and end of study visit. Laboratoryassessment shall be performed on screening and end of study visit. UrineExamination shall be performed during screening visit and end of study visit.12 Lead ECG examinations shall be performed during screening.

Ocular Assessments include: Afterinformed consent process, completion of all screening assessments and once allthe inclusion/exclusion criteria are met, the eligible subjects shall beenrolled into the study. Demographics, Medical and surgical history shall berecorded during screening visit. Details of concomitant medications and adverseevents if any shall be recorded during each visit. Physical examination shallbe done during screening and each successive visit. Vital signs shall bemeasured on each visit and Lab parameters will perform. Ocular Assessmentsinclude: Mesopic, high contrast DCNVA and Photopic, high contrast DCNVAfor each eye and binocularly will be assessed at Screening, Days 1, 14, and 30with time in-travels.

At randomization/baseline visit,subjects shall be randomly assigned in 1:1 fashion to one of the two studygroups.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 234

Inclusion Criteria

Adult male and female subjects, 45 to 55 years of age (both inclusive).
Subjects with Objective and subjective evidence of Presbyopia.
Subjects with subjective complaints of poor near vision that impacts the activity of daily living.
Subjects with photopic, high-contrast corrected distance visual acuity (CDVA) of 20/25 or better bilaterally; mesopic, high-contrast distance-corrected near visual acuity (DCNVA, measured at 40 cm) of 20/40 to 20/100; photopic, near visual acuity correctable to 20/40 or better bilaterally 5.
Subjects with willingness to wear monofocal correction to achieve photopic, binocular CDVA of 20/32 or better during the study (if required).
Subjects who are able to understand and give voluntary, written informed consent to participate in this clinical investigation and from whom written consent has been obtained.
Subjects shall be willing and able to understand and comply with the requirements of the study, administer the study medication as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
Female Subjects, of child-bearing potential practicing an acceptable method of birth control such as sexual abstinence, intrauterine device IUD, birth control pills, a double-barrier method, transdermal, injection or implants, non-hormonal or hormonal, condom plus spermicide, diaphragm plus spermicide, or vaginal spermicidal suppository; for the duration of the study as judged by the investigator(s)/study physician and agree to follow the same should be used during treatment OR Postmenopausal for at least 1 year OR Surgically sterile (bilateral tubal ligation/bilateral oophorectomy/ hysterectomy has been performed on the Subject).

Exclusion Criteria

Documented/suspected history of hypersensitivity to the study medications or any of the ingredients of the formulation or cholinergic agonist medications.
Subjects with History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any other intraocular surgery.
However, Subjects with history of Photorefractive keratectomy (PRK) or Laser-assisted in situ keratomileusis (LASIK) with CDVA meeting inclusion criteria will be allowed to enrol.
Subjects with concurrent use of any topical ophthalmic medications including artificial tears, other than the study intervention during the course of the study.
Subjects with concurrent use of temporary or permanent punctual plugs or history of punctual cautery in one or both eyes.
Subjects with current enrolment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
Subjects with participation in a blood or plasma donation program within 30 days prior to the study intervention administration.
Subjects with severe dry eye disease 8.
Subjects with corneal abnormalities (including Keratoconus, corneal scar, Fuchâ€™s endothelial dystrophy, guttata or edema) in either eye that are likely to interfere the visual acuity.
Subjects with history of iris trauma, Adieâ€™s tonic pupil, abnormal pupil shape in either eye, or anisocoria >1mm between pupils under mesopic conditions at the screening visit.
Subjects with all grades of cataract.
Subjects with diagnosis of Glaucoma or ocular Hypertension.
Subjects with Bifocal or multifocal spectacles or contact lenses for habitual correction.
Females who are pregnant, nursing or planning a pregnancy during the study.
Subjects with history of chronic, recurrent, or current severe inflammatory eye disease (i.e., scleritis, uveitis, herpes keratitis) in either eye.
Subjects with documented history of ocular trauma â‰¤ 6 months before the study.
Subjects with documented history of clinically significant or progressive retinal disease (e.g., retinal degeneration, diabetic retinopathy, retinal detachment) in either eye.
Subjects with one eye.
Subjects with severe illness or other condition that would make the patient unsuitable for the study, as per investigator discretion.
Subjects with active or prior severe, unstable, or uncontrolled cardiovascular, cerebrovascular, hepatic, or renal disease.
Subjects with use of topical ophthalmic corticosteroid within two weeks prior to baseline visit.
Subjects with use of intraocular corticosteroid implant at any time prior to baseline visit.
Subjects with clinically significant laboratory abnormalities at the time of screening.
Currently taking prohibited concomitant medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
Subjects who are known seropositive cases of HIV, Hepatitis B or Hepatitis C.
Subjects who have a recent history or who are currently known to abuse alcohol or drugs.
Suspected inability or unwillingness to comply with the protocol or other study procedures.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects Gaining 3 Lines or More in Mesopic (10-11 lux at the target), High contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30	Hour 3 -(Day 1); Hour 3 (Day 3); Hour 3 - (Day 7); Hour 3 (Day 14) and Day 30 (Hour 3)

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects gaining 3 or more lines in mesopic, high-contrast, binocular DCNVA	Baseline (Day 1) to Day 30 (Hour 8)
Change From Baseline in Mesopic, High-contrast, Binocular DCNVA Letters	Baseline (Day 1) to Day 30 (Hours 0.25 & 0.5)
Proportion of Subjects Achieving 20/40 or Better in Photopic (251 lux at the target), High contrast, Binocular, DCNVA	Day 30 (Hour 1 & 3)
Mean change from baseline in photopic, high-contrast, binocular distance-corrected	intermediate visual acuity (DCIVA; measured at 66 cm) letters
Mean Change From Baseline in Mesopic Near Vision Presbyopia Task-based Questionnaire	(NVPTQ) Performance Score

Trial Locations

Locations (13): AIIMS, Bhubanwswar
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Khordha, ORISSA, India
Anand Multispeciality Hospital and Research Centre
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Ahmadabad, GUJARAT, India
Culcutta National Medical College and Hospital
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Kolkata, WEST BENGAL, India
Department of Ophthalmology, GSVM Medical College.
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Nagar, UTTAR PRADESH, India
Government Medical College & Government General Hospital (Old RIMSGGH)
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Srikakulam, ANDHRA PRADESH, India
IPGME & R and SSKM Hospital.
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Kolkata, WEST BENGAL, India
Kanoria Hospital Research Centre
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Gandhinagar, GUJARAT, India
M N eye Hospital, Chennai
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Chennai, TAMIL NADU, India
Maharaja Agrasen Hospital West Punjabi Bagh
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Delhi, DELHI, India
Matis Multi-speciality Hospital
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Ahmadabad, GUJARAT, India
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AIIMS, Bhubanwswar
🇮🇳Khordha, ORISSA, India
Dr Sucheta Parija
Principal investigator
9437044380
suchetaparija@yahoo.com