Glaucoma, Open-AngleNCT01430923
Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost
A study testing refrigeration free latanoprost and latanoprost eye drops in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Aurolab at 1 site in India.
Trial summary
The purpose of this study is to: To evaluate the efficacy of Refrigeration-Free Latanoprost compared to Latanoprost stored at refrigeration temperature with respect to the diurnal intraocular pressure (IOP) change from baseline after 3 months of therapy in patients with open-angle glaucoma (OAG) or ocular… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glaucoma, Open-Angle, Ocular Hypertension
- What is being tested?
- refrigeration free latanoprost and latanoprost eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient between 18 and 80 years of age
- Newly diagnosed Primary Open-Angle Glaucoma, Pigmentary Glaucoma, Pseudoexfoliation, or Ocular hypertension.
- Patient has a mean (or median) IOP of 24 and 36 mmHg in at least one eye
- Patient has a best corrected ETDRS visual acuity score of +0.6 logMAR (Snellen equivalent of 20/80) or better in each eye.
- Patient should have the access / ability to refrigerate study drug.
- Residence with 60 kms of Madurai
Who cannot join
- Patient has a mean (or median) IOP >36 mmHg in either eye at the Screening Visit.
- Patient has a history of or current abnormal corneal sensation or any abnormality in either eye preventing reliable Goldmann applanation tonometry
- Pupil in either eye that will not dilate sufficiently for adequate evaluation of the retina
- Patient has a history of retinal detachment, proliferative diabetic retinopathy, or any retinal disease in either eye that may be progressive during the study
- Patient who has significant ocular symptoms or signs such as photophobia, flashes or streaks of light, metamorphopsia, diplopia, or transient loss of vision in either eye.
- Patient has had intraocular surgery (e.g., cataract extraction) in either eye within 4months prior to Screening visit.
- Patient is aphakic or has, in the judgement of the investigator, risk for ocular inflammation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized,Active Comparator-Controlled,Three Months,Open Label Clinical Trial to Compare Efficacy and Safety of Refrigeration-Free Latanoprost (0.005%) and Latanoprost (0.005%) Stored at Refrigeration Temperature in Patients With OAG or OHT
The purpose of this study is to:
- To evaluate the efficacy of Refrigeration-Free Latanoprost compared to Latanoprost stored at refrigeration temperature with respect to the diurnal intraocular pressure (IOP) change from baseline after 3 months of therapy in patients with open-angle glaucoma (OAG) or ocular hypertension.
- To evaluate the safety and tolerability of Refrigeration-Free Latanoprost in patients with open-angle glaucoma (OAG) or ocular hypertension.
Read the detailed description
Latanoprost refrigeration free formulation is developed to overcome difficulties on storing drugs at 2-8˚ C in consumer end and also to avoid risk during transition. This formulation has the best solubilizing agent cyclodextrin to increase the solubility and stability of latanoprost API. To find out the efficacy and safety due to this additional excipient in this formulation rather than the cold storage product the investigators have to perform clinical trial.
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Being tested
- refrigeration free latanoprost, latanoprost eye drops
- Keywords
- Refrigeration free latanoprost
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
refrigeration free latanoprostDrug
Also called Auroprost RT
latanoprost Eye drops 0.005% once daily, 3 months
latanoprost eye dropsDrug
Also called Auroprost
latanoprost eye drops 0.005% w/v, once daily, 3 months
| Study group | Role | What they receive |
|---|---|---|
| Refrigeration free Latanoprost | Experimental | Latanoprost refrigeration free formulation as per randomization schedule. Receives: Drug: refrigeration free latanoprost |
| latanoprost 2-8˚ C | Active comparator | latanoprost stored at 2-8˚ C Receives: Drug: latanoprost eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
to evalate the change in intraocular pressure from baseline to end of treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionMay 2012
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aurolab
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Manju R Pillai, MBBS.,, Principal investigator, Araving Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430923
- Sponsor's protocol ID
- LATANOPROST/CIP/002/2011
- Status last verified
- Jul 2012
- First submitted
- 7 Sep 2011
- Last updated
- 12 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized,Active Comparator-Controlled,Three Months,Open Label Clinical Trial to Compare Efficacy and Safety of Refrigeration-Free Latanoprost (0.005%) and Latanoprost (0.005%) Stored at Refrigeration Temperature in Patients With OAG or OHT
- ClinicalTrials.gov ID
- NCT01430923
- Acronym / sponsor ID
- LATANOPROST/CIP/002/2011
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Keywords
- Refrigeration free latanoprost
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- AurolabUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Aug 2012 (estimated)
- First posted
- 9 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to:
- To evaluate the efficacy of Refrigeration-Free Latanoprost compared to Latanoprost stored at refrigeration temperature with respect to the diurnal intraocular pressure (IOP) change from baseline after 3 months of therapy in patients with open-angle glaucoma (OAG) or ocular hypertension.
- To evaluate the safety and tolerability of Refrigeration-Free Latanoprost in patients with open-angle glaucoma (OAG) or ocular hypertension.
Detailed description
Latanoprost refrigeration free formulation is developed to overcome difficulties on storing drugs at 2-8˚ C in consumer end and also to avoid risk during transition. This formulation has the best solubilizing agent cyclodextrin to increase the solubility and stability of latanoprost API. To find out the efficacy and safety due to this additional excipient in this formulation rather than the cold storage product the investigators have to perform clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Refrigeration free Latanoprost | Experimental | Drug: refrigeration free latanoprostLatanoprost refrigeration free formulation as per randomization schedule. |
| latanoprost 2-8˚ C | Active comparator | Drug: latanoprost eye dropslatanoprost stored at 2-8˚ C |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient between 18 and 80 years of age
- Newly diagnosed Primary Open-Angle Glaucoma, Pigmentary Glaucoma, Pseudoexfoliation, or Ocular hypertension.
- Patient has a mean (or median) IOP of 24 and 36 mmHg in at least one eye
- Patient has a best corrected ETDRS visual acuity score of +0.6 logMAR (Snellen equivalent of 20/80) or better in each eye.
- Patient should have the access / ability to refrigerate study drug.
Key exclusion criteria (7 listed)
- Patient has a mean (or median) IOP >36 mmHg in either eye at the Screening Visit.
- Patient has a history of or current abnormal corneal sensation or any abnormality in either eye preventing reliable Goldmann applanation tonometry
- Pupil in either eye that will not dilate sufficiently for adequate evaluation of the retina
- Patient has a history of retinal detachment, proliferative diabetic retinopathy, or any retinal disease in either eye that may be progressive during the study
- Patient who has significant ocular symptoms or signs such as photophobia, flashes or streaks of light, metamorphopsia, diplopia, or transient loss of vision in either eye.
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 |
|---|---|---|
| refrigeration free latanoprostAlso: Auroprost RTlatanoprost Eye drops 0.005% once daily, 3 months | Drug | Refrigeration free Latanoprost |
| latanoprost eye dropsAlso: Auroprostlatanoprost eye drops 0.005% w/v, once daily, 3 months | Drug | latanoprost 2-8˚ C |
Primary outcome
Intraocular pressure
Time frame: 3 months
to evalate the change in intraocular pressure from baseline to end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2012.
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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.
Dr. Manju R Pillai, MBBS., principal investigator
Araving Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing refrigeration free latanoprost and latanoprost eye drops in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Aurolab at 1 site in India.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 Jul 2012. 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 India. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
Intraocular pressure (time frame: 3 months). 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 12 Jul 2012.