Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost
This study is ongoing, but not recruiting participants.
Sponsor:
Aurolab
Information provided by (Responsible Party):
Aurolab
ClinicalTrials.gov Identifier:
NCT01430923
First received: September 7, 2011
Last updated: July 11, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Glaucoma, Open-Angle Ocular Hypertension |
Drug: refrigeration free latanoprost Drug: latanoprost eye drops |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Aurolab:
Primary Outcome Measures:
- Intraocular pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]to evalate the change in intraocular pressure from baseline to end of treatment
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | August 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Refrigeration free Latanoprost
Latanoprost refrigeration free formulation as per randomization schedule.
|
Drug: refrigeration free latanoprost
latanoprost Eye drops 0.005% once daily, 3 months
Other Name: Auroprost RT
|
|
Active Comparator: latanoprost 2-8˚ C
latanoprost stored at 2-8˚ C
|
Drug: latanoprost eye drops
latanoprost eye drops 0.005% w/v, once daily, 3 months
Other Name: Auroprost
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Aurolab |
| ClinicalTrials.gov Identifier: | NCT01430923 History of Changes |
| Other Study ID Numbers: | LATANOPROST/CIP/002/2011 |
| Study First Received: | September 7, 2011 |
| Last Updated: | July 11, 2012 |
| Health Authority: | India: Ministry of Health |
Keywords provided by Aurolab:
|
Refrigeration free latanoprost |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Open-Angle Hypertension Ocular Hypertension Eye Diseases Vascular Diseases Cardiovascular Diseases Tetrahydrozoline Latanoprost Nasal Decongestants |
Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Respiratory System Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antihypertensive Agents |
ClinicalTrials.gov processed this record on May 16, 2013