Dry EyeNCT04465071
Lubricating Eye Drops After Routine Cataract Surgery
A study testing AEONTM Repair and AEONTM Protect Plus lubricating eye drops in people with Dry Eye and Cataract, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Patient satisfaction and dry symptoms in patients undergoing routine uncomplicated cataract surgery in NHS patients treated with prophylactic phosphate-free, preservative-free lubricant eye drops (0.3% cross linked sodium hyaluronate, AEONTM Protect Plus and0.15% Sodium Hyalu-ronate with vitamins A and E, AEONTM… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- What is being tested?
- AEONTM Repair and AEONTM Protect Plus lubricating eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Feb 2020to 31 Aug 2022
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Bilateral or unilateral cataracts requiring surgical intervention
- Age over 18 years
- Able to understand informed consent and the objectives of the trial
- Not pregnant, not breast feeding
- No previous eye surgery
Who cannot join
- age-related macula degeneration
- glaucoma
- previous retinal vascular disorders
- previous retinal detachment or tear
- any neuro-ophthalmological condition
- any inherited retinal disorder or pathology
Show all 10Show fewer
- previous strabismus surgery or record of amblyopia
- previous TIA, CVA or other vaso-occlusive disease
- already enrolled in another study
- already on prescribed lubricating drops
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Satisfaction,Dry Symptoms in Patients Cataract Surgery in NHS Patients Treated With Prophylactic Preservative-free Lubricant Eye Drops (AEONTM Repair, and AEONTM Protect Plus): A Randomized, Prospective, Controlled Study.
Patient satisfaction and dry symptoms in patients undergoing routine uncomplicated cataract surgery in NHS patients treated with prophylactic phosphate-free, preservative-free lubricant eye drops (0.3% cross linked sodium hyaluronate, AEONTM Protect Plus and0.15% Sodium Hyalu-ronate with vitamins A and E, AEONTM Repair): A randomized, prospective, controlled study.
Read the detailed description
The aim of this study is to investigate the routine use of such lubricating drops in a randomized, prospective methodology in patients undergoing uncomplicated cataract surgery in the NHS setting. As these drops are provided with the intraocular lens, if found to be of benefit in reducing dry eye problems such a study might provide evidence for the universal implementa-tion of post-operative ocular lubricant drops
- Being tested
- AEONTM Repair and AEONTM Protect Plus lubricating eye drops
- Medical subject headings
- Dry Eye Syndromes, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AEONTM Repair and AEONTM Protect Plus lubricating eye dropsDrug
AEONTM Repair and AEONTM Protect Plus lubricating eye drops
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment | No intervention | Post-Cataract surgery standard treatment of Maxidex 0.1% QDS for 4 weeks, and Chloramphenicol drops QDS for 2 weeks |
| Standard Treatment plus lubricating drops | Other | Lubricant eye-drops (0.3% cross linked sodium hyaluronate, AEONTM Protect Plus and phosphate-free, preservative-free lubricant eye drops containing 0.15% Sodium Hyaluronate with vita-mins A and E (AEONTM Repair) for 6 weeks post-Cataract surgery, in addition to the standard treatment of Maxidex 0.1% QDS for 4 weeks, and Chloramphenicol drops QDS for 2 weeks Receives: Drug: AEONTM Repair and AEONTM Protect Plus lubricating eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
CATPROM 5 patient satisfaction score
Quality of life patient satisfaction questionnaire
Measured: Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change
EQ5D3L patient satisfaction score
Quality of life patient satisfaction questionnaire
Measured: Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change
Dry Eye Symptoms
Patient questionnaire SPEED II score (Maximum 28, Minimum 0)
Measured: Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change
Secondary outcomes (6)
Visual Acuity
Logmar Visual Acuity
Measured: 2 week follow up and 2 month follow up
Cornea and Conjunctival Staining
Oxford Scale (Maximum 5, minimum 0)
Measured: 2 week follow up and 2 month follow up
Schirmer 1 Test
Schirmer 1 Test (Normal >10 mm)
Measured: 2 week follow up and 2 month follow up
Tear Break up time
Non-invasive tear breakup time (normal >10 seconds)
Measured: 2 week follow up and 2 month follow up
Inferior tear meniscus
Inferior tear meniscus
Measured: 2 week follow up and 2 month follow up
Corneal Incision site and size
Corneal Incision site and size
Measured: 2 week follow up and 2 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start24 Feb 2020
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To assess the use of additional lubricant eye-drops for 6 weeks following uncomplicated, routine cataract sur-gery to improve patient satisfaction and symptoms of dry eye in an NHS (public health care) setting, compared to no additional lubricating eye drops
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- City, University of London, King's College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465071
- Sponsor's protocol ID
- 276400
- Status last verified
- Sep 2023
- First submitted
- 21 Feb 2020
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction,Dry Symptoms in Patients Cataract Surgery in NHS Patients Treated With Prophylactic Preservative-free Lubricant Eye Drops (AEONTM Repair, and AEONTM Protect Plus): A Randomized, Prospective, Controlled Study.
- ClinicalTrials.gov ID
- NCT04465071
- Acronym / sponsor ID
- 276400
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- City, University of London, King's College London
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 9 Jul 2020 (actual)
- 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.
Patient satisfaction and dry symptoms in patients undergoing routine uncomplicated cataract surgery in NHS patients treated with prophylactic phosphate-free, preservative-free lubricant eye drops (0.3% cross linked sodium hyaluronate, AEONTM Protect Plus and0.15% Sodium Hyalu-ronate with vitamins A and E, AEONTM Repair): A randomized, prospective, controlled study.
Detailed description
The aim of this study is to investigate the routine use of such lubricating drops in a randomized, prospective methodology in patients undergoing uncomplicated cataract surgery in the NHS setting. As these drops are provided with the intraocular lens, if found to be of benefit in reducing dry eye problems such a study might provide evidence for the universal implementa-tion of post-operative ocular lubricant drops
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To assess the use of additional lubricant eye-drops for 6 weeks following uncomplicated, routine cataract sur-gery to improve patient satisfaction and symptoms of dry eye in an NHS (public health care) setting, compared to no additional lubricating eye drops
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment | No intervention | –Post-Cataract surgery standard treatment of Maxidex 0.1% QDS for 4 weeks, and Chloramphenicol drops QDS for 2 weeks |
| Standard Treatment plus lubricating drops | Other | Drug: AEONTM Repair and AEONTM Protect Plus lubricating eye dropsLubricant eye-drops (0.3% cross linked sodium hyaluronate, AEONTM Protect Plus and phosphate-free, preservative-free lubricant eye drops containing 0.15% Sodium Hyaluronate with vita-mins A and E (AEONTM Repair) for 6 weeks post-Cataract surgery, in addition to the standard treatment of Maxidex 0.1% QDS for 4 weeks, and Chloramphenicol drops QDS for 2 weeks |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Bilateral or unilateral cataracts requiring surgical intervention
- Age over 18 years
- Able to understand informed consent and the objectives of the trial
- Not pregnant, not breast feeding
- No previous eye surgery
Key exclusion criteria (10 listed)
- age-related macula degeneration
- glaucoma
- previous retinal vascular disorders
- previous retinal detachment or tear
- any neuro-ophthalmological condition
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 |
|---|---|---|
| AEONTM Repair and AEONTM Protect Plus lubricating eye dropsAEONTM Repair and AEONTM Protect Plus lubricating eye drops | Drug | Standard Treatment plus lubricating drops |
Primary outcome
CATPROM 5 patient satisfaction score
Time frame: Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change
Quality of life patient satisfaction questionnaire
EQ5D3L patient satisfaction score
Time frame: Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change
Quality of life patient satisfaction questionnaire
Dry Eye Symptoms
Time frame: Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change
Patient questionnaire SPEED II score (Maximum 28, Minimum 0)
6 secondary outcomes
Visual Acuity
Time frame: 2 week follow up and 2 month follow up
Cornea and Conjunctival Staining
Time frame: 2 week follow up and 2 month follow up
Schirmer 1 Test
Time frame: 2 week follow up and 2 month follow up
Tear Break up time
Time frame: 2 week follow up and 2 month follow up
Inferior tear meniscus
Time frame: 2 week follow up and 2 month follow up
Corneal Incision site and size
Time frame: 2 week follow up and 2 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No
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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 study testing AEONTM Repair and AEONTM Protect Plus lubricating eye drops in people with Dry Eye and Cataract, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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 5 inclusion and 10 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 13 Sep 2023. 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 Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CATPROM 5 patient satisfaction score (time frame: Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change). The study lists 3 primary outcomes in all. 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 13 Sep 2023.