CataractPhase 3NCT03499873
Clinical Endpoint Study of Nepafenac 0.3% Opthalmic Suspension
A Phase 3 study testing Nepafenac 0.3% Oph Susp and Nepafenac 0.3% Oph Susp (reference) in people with Cataract, run by Actavis Inc. at 1 site in United States.
Trial summary
A randomized, multicenter, double masked, placebo controlled, parallel group, bioequivalence study to evaluate the clinical equivalence and safety of Nepafenac 0.3% ophthalmic suspension (manufactured by Indoco remedies Ltd. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Nepafenac 0.3% Oph Susp and Nepafenac 0.3% Oph Susp (reference)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 448 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2018to 18 Dec 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or non-pregnant, non-lactating females, 18 years of age or older who have a cataract and are expected to undergo cataract extraction.
- No aqueous cells, no visible aqueous flare and no significant ocular pain in the selected eye noted during the Screening visit by slit-lamp examination.
- Study subjects must have provided IRB approved written informed consent using the latest version of the IRB informed consent form. In addition, study subjects must sign a HIPAA authorization, if applicable.
- Study subjects should be literate and willing to complete the subject diary regularly as directed.
- Study subjects must be in good health and free from any clinically significant disease apart from indication under study.
- Females of child bearing potential (WOCBP*) must not be pregnant or lactating at baseline visit (as documented by a negative urine pregnancy test with a minimum sensitivity of 25 IU/L or equivalent units of beta-human chorionic gonadotropin (Beta-HCG) at screening and urine pregnancy at baseline.
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- Female subjects of childbearing potential must be willing to use an acceptable form of birth control from the day of the first dose administration to 30 days after the last administration of IP. For the purpose of this study the following are considered acceptable methods of birth control: oral or injectable contraceptives, contraceptive patches, Depo-Provera® (Medroxyprogesterone acetate-stabilized for at least 3 months); vaginal contraceptive; contraceptive implant; double barrier methods (e.g. condom and spermicide); Nuvaring vaginal hormonal birth control, IUD, or abstinence with a second method of birth control should the subject become sexually active. A sterile sexual partner is NOT considered an adequate form of birth control.
- All male subjects must agree to use accepted methods of birth control with their partners, from the day of the first dose administration (to 30 days after the last administration of study drug). Please see acceptable forms for "Female" birth control above. Abstinence is an acceptable method of birth control for males.
- Study subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required scheduled study visits.
- Study subjects must be willing to refrain from using any other treatments other than the investigational product.
Who cannot join
- Females who are pregnant, breast feeding, or planning a pregnancy during the course of the study and for 30 days after last study dose.
- Females of childbearing potential who do not agree to utilize an adequate form of contraception.
- Current or past history of severe hepatic or renal impairment, uncontrolled diabetes mellitus, rheumatoid arthritis or bleeding tendencies.
- Current or history within two months prior to baseline of clinically significant ocular disease, e.g., corneal denervation, corneal epithelial defects, severe dry eye syndrome, ocular trauma to the operative eye, corneal edema, proliferative diabetic retinopathy in the operative eye or ocular infection.
- In the operative eye, history of chronic or recurrent inflammatory disease, e.g., iritis, scleritis, uveitis, iridocyclitis or rubeosis iritis, lens pseudoexfoliation syndrome with glaucoma or zonular compromise.
- Congenital ocular anomaly, e.g., aniridia or congenital cataract.
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- Iris atrophy in the operative eye.
- Current corneal abnormalities that would prevent accurate IOP readings with the Goldmann applanation tonometer.
- Nonfunctional nonoperative eye (visual acuity of 20/200 or worse Snellen or ETDRS).
- Known hypersensitivity to any component of nepafenac therapy or to other nonsteroidal anti-inflammatory drug (NSAID).
- Use within one week prior to baseline of: 1) contact lens, or 2) topical, ophthalmic or systemic NSAID.
- Use within two weeks prior to baseline of: 1) topical ophthalmic corticosteroid, 2) topical corticosteroid, or 3) medications which may prolong bleeding time (per investigator discretion and primary care physician approval to discontinue use for surgery).
- Use within one month prior to baseline of: 1) systemic corticosteroid, 2) high-dose salicylate therapy, or 3) topical ophthalmic prostaglandin analogs, e.g., bimatoprost, latanoprost or travoprost.
- Use within six months prior to baseline of intravitreal or subtenon injection of ophthalmic corticosteroid.
- Underwent within six months prior to baseline any complicated intraocular surgery or repeat ocular surgeries (e.g., cataract surgery).
- Underwent within twelve months prior to baseline: refractive surgery, filtering surgery or laser surgery for IOP reduction.
- History or presence of significant alcoholism or drug abuse in the past one year.
- History or presence of significant smoking (more than 20 cigarettes or any other equivalent tobacco product/day).
- History of hematologic disorders other than mild anemia.
- Severe, unstable, or uncontrolled cardiovascular or pulmonary disease.
- Therapy with an investigational agent within the past 30 days prior to screening.
- Clinically significant hematologic and / or biochemical abnormalities based on laboratory testing.
- Subjects who are in the investigator's best judgment at risk of visual field or visual acuity worsening as a consequence of participation in trial.
- Use of any prescribed medication during last two weeks or OTC medicinal products during the last one week preceding the first dosing that results in drug-drug interaction with the study drug.
- Major illness, as per investigator discretion, during 3 months before screening.
- Subjects who are employees of site or CRO or sponsor or immediate family of employees.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Multicenter, Double Masked, Placebo Controlled, Parallel Group, Bioequivalence Study to Evaluate the Clinical Equivalence and Safety of Nepafenac 0.3% Ophthalmic Suspension (Manufactured by Indoco Remedies Ltd. for Actavis LLC) With IlevroTM (Nepafenac Ophthalmic Suspension), 0.3% of Alcon Laboratories, Inc. for the Treatment of Pain and Inflammation Associated With Cataract Surgery.
A randomized, multicenter, double masked, placebo controlled, parallel group, bioequivalence study to evaluate the clinical equivalence and safety of Nepafenac 0.3% ophthalmic suspension (manufactured by Indoco remedies Ltd. for Actavis LLC) with IlevroTM (Nepafenac ophthalmic suspension), 0.3% of Alcon Laboratories, Inc. for the treatment of pain and inflammation associated with cataract surgery.
- Conditions
- Cataract
- Being tested
- Nepafenac 0.3% Oph Susp, Placebos, Nepafenac 0.3% Oph Susp (reference)
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nepafenac 0.3% Oph SuspDrug
Nepafenac 0.3% Ophthalmic suspension (experimental product)
PlacebosDrug
Placebo
Nepafenac 0.3% Oph Susp (reference)Drug
Nepafenac 0.3% Ophthalmic suspension (Innovator)
| Study group | Role | What they receive |
|---|---|---|
| Nepafenac 0.3% Opthalmic Suspension | Experimental | Test product manufactured by Indoco Remedies, Ltd for Actavis LLC. Receives: Drug: Nepafenac 0.3% Oph Susp |
| Ilevro 0.3% Opthalmic Suspension | Active comparator | Reference product manufactured by Alcon Laboratories Inc. Receives: Drug: Nepafenac 0.3% Oph Susp (reference) |
| Placebo (vehicle) Opthalmic Suspension | Placebo comparator | Placebo (vehicle) manufactured by Indoco Remedies, Ltd for Actavis LLC. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure at Day 14
Number of participants that achieved cure at Day 14 defined as a score of 0 for aqueous cells (Grade 0-4 using a narrow-slit beam (0.5 mm width at least 8 mm length) at maximum luminance), a score of 0 for aqueous flare (Grade 0-3 using a narrow-slit beam (0.5 mm width at least 8 mm length) at maximum luminance) and a score of no more than 3 for pain (Grade 0-5 a positive sensation of the eye, including foreign body sensation, stabbing, throbbing or aching). The scoring indicates from less severe at 0 to very severe as the grading increases.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start28 Mar 2018
- Primary completion31 Oct 2018
- Study completion18 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499873
- Sponsor's protocol ID
- TCTM/NEPA/2017
- Status last verified
- Jan 2021
- First submitted
- 23 Mar 2018
- Last updated
- 16 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double Masked, Placebo Controlled, Parallel Group, Bioequivalence Study to Evaluate the Clinical Equivalence and Safety of Nepafenac 0.3% Ophthalmic Suspension (Manufactured by Indoco Remedies Ltd. for Actavis LLC) With IlevroTM (Nepafenac Ophthalmic Suspension), 0.3% of Alcon Laboratories, Inc. for the Treatment of Pain and Inflammation Associated With Cataract Surgery.
- ClinicalTrials.gov ID
- NCT03499873
- Acronym / sponsor ID
- TCTM/NEPA/2017
- Conditions
- Cataract
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 18 Dec 2018 (actual)
- First posted
- 17 Apr 2018 (actual)
- Results
- Posted 16 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, multicenter, double masked, placebo controlled, parallel group, bioequivalence study to evaluate the clinical equivalence and safety of Nepafenac 0.3% ophthalmic suspension (manufactured by Indoco remedies Ltd. for Actavis LLC) with IlevroTM (Nepafenac ophthalmic suspension), 0.3% of Alcon Laboratories, Inc. for the treatment of pain and inflammation associated with cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nepafenac 0.3% Opthalmic Suspension | Experimental | Drug: Nepafenac 0.3% Oph SuspTest product manufactured by Indoco Remedies, Ltd for Actavis LLC. |
| Ilevro 0.3% Opthalmic Suspension | Active comparator | Drug: Nepafenac 0.3% Oph Susp (reference)Reference product manufactured by Alcon Laboratories Inc. |
| Placebo (vehicle) Opthalmic Suspension | Placebo comparator | Drug: PlacebosPlacebo (vehicle) manufactured by Indoco Remedies, Ltd for Actavis LLC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males or non-pregnant, non-lactating females, 18 years of age or older who have a cataract and are expected to undergo cataract extraction.
- No aqueous cells, no visible aqueous flare and no significant ocular pain in the selected eye noted during the Screening visit by slit-lamp examination.
- Study subjects must have provided IRB approved written informed consent using the latest version of the IRB informed consent form. In addition, study subjects must sign a HIPAA authorization, if applicable.
- Study subjects should be literate and willing to complete the subject diary regularly as directed.
- Study subjects must be in good health and free from any clinically significant disease apart from indication under study.
Key exclusion criteria (26 listed)
- Females who are pregnant, breast feeding, or planning a pregnancy during the course of the study and for 30 days after last study dose.
- Females of childbearing potential who do not agree to utilize an adequate form of contraception.
- Current or past history of severe hepatic or renal impairment, uncontrolled diabetes mellitus, rheumatoid arthritis or bleeding tendencies.
- Current or history within two months prior to baseline of clinically significant ocular disease, e.g., corneal denervation, corneal epithelial defects, severe dry eye syndrome, ocular trauma to the operative eye, corneal edema, proliferative diabetic retinopathy in the operative eye or ocular infection.
- In the operative eye, history of chronic or recurrent inflammatory disease, e.g., iritis, scleritis, uveitis, iridocyclitis or rubeosis iritis, lens pseudoexfoliation syndrome with glaucoma or zonular compromise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nepafenac 0.3% Oph SuspNepafenac 0.3% Ophthalmic suspension (experimental product) | Drug | Nepafenac 0.3% Opthalmic Suspension |
| PlacebosPlacebo | Drug | Placebo (vehicle) Opthalmic Suspension |
| Nepafenac 0.3% Oph Susp (reference)Nepafenac 0.3% Ophthalmic suspension (Innovator) | Drug | Ilevro 0.3% Opthalmic Suspension |
Primary outcome
Cure at Day 14
Time frame: 14 days
Number of participants that achieved cure at Day 14 defined as a score of 0 for aqueous cells (Grade 0-4 using a narrow-slit beam (0.5 mm width at least 8 mm length) at maximum luminance), a score of 0 for aqueous flare (Grade 0-3 using a narrow-slit beam (0.5 mm width at least 8 mm length) at maximum luminance) and a score of no more than 3 for pain (Grade 0-5 a positive sensation of the eye, including foreign body sensation, stabbing, throbbing or aching). The scoring indicates from less severe at 0 to very severe as the grading increases.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nepafenac 0.3% Oph Susp and Nepafenac 0.3% Oph Susp (reference) in people with Cataract, run by Actavis Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure at Day 14 (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.